All Positions

Jobs - Julie Bukar - Founder - JGB BioPharma Consulting Inc

Our job site is updated frequently. New jobs appear on the top of the Complete Job Openings Listing. However, please feel free to send your resume or an email inquiry to Jobs@JGBBioPharma.com. Then we can contact you if a good job fit arises.

< Back to Jobs home

1) Technician – Contract (New Jersey) 8224

2) Associate Scientist I - R&D – Contract (San Francisco Bay Area) 73P7780

3) Senior Director Clinical Development, Respiratory – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) H111BV

4) Administrative / Professional - Administrative – Contract (Massachusetts) 2999

5) General Warehouse Worker – Contract (Pennsylvania) 7358

6) Administrative Assistant II – Contract (New Jersey) 3638

7) Admininistrative / Professional – HR – Contract (New Jersey) 7541

8) Senior Java Server Developer - Bioinformatics – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) P103LA

9) Senior Scientist – Analytical Chemistry – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A106JY

10) Senior Front End Developer for Bioinformatics – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) FB103T

11) Director / Executive Director, Regulatory Affairs – Full Time (Boston Area) GR110B

12) Non Promotional Program Specialist – Contract (New Jersey) 2537

13) Sr. Director, Clinical Regulatory Affairs – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) EH113K

14) Administrative / Professional - Professional – Contract (New Jersey) 2662

15) Scientist (BS or MS) – Contract (Pennsylvania) 8672

16) Recruiter – Contract (Pennsylvania) 4494

17) Data Entry Specialist – Contract (Massachusetts) 9190

18) Records Manager – Contract (Pennsylvania) 4610

19) EHS Coordinator – Contract (Southern California) 1461D73

20) Manager, Clinical Operations, Oncology – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) HL113W

21) Senior Clinical Research Associate – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GT113P

22) Scientist II / Senior Scientist Pharmacokinetics/Pharmacodynamics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) F113KV

23) Research Associate 1 – 6 Month Contract (San Jose Area) A132FV

24) Associate Director, Project Management – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BL140Y

25) Operations Project & Budget Coordinator – Contract (New Jersey) 0002

26) Biostatistician – Contract (New Jersey) 9129

27) Administrative / Professional - Professional – Contract (New Jersey) 7253

28) Director / Sr Director, International Operations – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) G127KM

29) Associate CMC Director, Regulatory Affairs – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A113HN

30) Scientist II, III - Protein Chemistry – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GR139H

31) CRA III / Sr CRA – Clinical Operations – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) MB139W

32) Clinical Trial Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A129DK

33) Marketing Development Manager – Contract (San Francisco Bay Area) 73Y1848

34) Accounts Receivables Clerk – Contract (New York) 73P1775

35) SCRA / CTM (Clinical Operations) – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) DH125N

36) Data Entry Operator – Contract (San Francisco Bay Area) 73M2018

37) Senior Project Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) G132XT

38) Marketing Development Manager – Contract (San Francisco Bay Area) 1149K73

39) Packaging Technician – Contract (Pennsylvania) 9389

40) Principle Investigator / Technical Writer – Contract (Pennsylvania) 8199

41) Engineering Technician – Contract (San Francisco Bay Area) 73G4864

42) Health, Safety, and Environment (HSE) Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) B131DM

43) Senior Biostatistician / Manager, Biostatistics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) B111DK

44) Statistician – Contract (New Jersey) 6150

45) Web Content Specialist – Contract (Southern California) 2894Q73

46) Sr Project Manager Process Improvements & Analytics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GP113F

47) Laboratory Technical Supervisor – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) Z138AG

48) Laboratory General Supervisor – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BX138R

49) Clinical Microbiology Supervisor – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) JP138C

50) Senior Clinical Trial Manager – Contract (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BT108K

51) Regulatory Affairs Associate / Specialist – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) XR111F

52) Scientist – Contract (Southern California) 73Z6685

53) Clinical Project Leader – Full Time (San Francisco/South Bay/Marin/Sonoma/Napa/Santa Rosa/Petaluma) W109FJ

54) Lab Tech – Contract (Texas) 5219X73

55) Clinical Project Leader – Full Time (San Francisco/South Bay/Marin/Sonoma/Napa/Santa Rosa/Petaluma) W109FJ

56) Scientist – Contract (Southern California) 6075N73

57) Financial Analyst – Contract (Southern California) 73L4185

58) Administrative Representative – Contract (New Jersey) 6222

59) Clinical Research Associate II – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) VF132D

60) Associate Scientist I - R&D – Contract (San Francisco Bay Area) 73A9814

61) Light Industrial – Contract (Pennsylvania) 0787

62) Manager / Sr Manager CMC Project Management – Full Time (New York) XL130F

63) Medical Writer – Contract (New Jersey) 6943

64) Analytical Chemist – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) Z122EJ

65) Sr QC Stabilty Associate / Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BL122T

66) Patient Access Program Lead Pharmacist / Nurse – Contract (Massachusetts) 6123

67) Sr. Project Manager / Associate Director, Oncology – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) P113FX

68) Associate Director / Director Regulatory Affairs – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) RF133J

69) Sr. Product Data Steward – Contract (Southern California) 73J1917

70) Regulatory Operations Associate – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A111JP

71) Senior Manager Development Sciences Operations Process Improvements and Analytics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) RG113T

72) Senior Manager Project and Clinical Process Analytics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) RG113T

73) Admininistrative / Professional – HR – Contract (New Jersey) 1265

74) Senior Project Manager / Associate Director – Contract to Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) G137AP

75) Scientist (BS or MS) – Contract (Pennsylvania) 7455

76) Regulatory Affairs, CMC Manager / Sr. Manager – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) X113PD

77) Medical Director, Clinical Development – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) GF129B

78) Clinical Assistant – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) M111YV

79) Senior Director / Director, Program Management – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) CY127F

80) Quality Compliance Team Lead (Asso Dir/ Director) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JY131K

81) Senior Manager/Associate Director, Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) K111DN

82) Senior Manager / Associate Director, Clinical Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) AL111H

83) Associate Director / Director, Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) W111EC

84) Senior Scientist (Process Chemical Development) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) PH111X

85) Chemical Engineer – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) H111BC

86) Scientist / Senior Scientist, Analytical Development (Small Molecules) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) AL111W

87) Scientist / Senior Scientist, Analytical Development (Biologics) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) G111RY

88) Clinical Pharmacologist – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A133GB

89) CRA I /II – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) S117JT

90) (Senior) Associate Manager CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) MA132W

91) Sr Manager , Scientific & Technical Publishing – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R132GL

92) Lab Tech – Contract (Texas) 5531M73

93) Senior Medical Director, Drug Safety – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) P111BL

94) Medical Director, Drug Safety – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) TM111Z

95) Director CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) XF132H

96) Manager / Sr. Manager CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) B132WN

97) Director / Sr. Director, Regulatory Affairs – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) G129FS

98) Associate Director / Sr. Manager Clinical Supply Chain – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JQ111V

99) Sr Clinical Supply Chain Coordinator – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R132BN

100) Associate Scientist II - R&D – Contract (San Francisco Bay Area) 1144F73

101) Technical Writer – Contract (Pennsylvania) 4062

102) Associate Director QC Team Lead – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A131AF

103) Patent Attorney, Director – Full Time (New York) XA130J

104) Clinical Program Manager – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) B94RP

105) Data Entry Operator – Contract (New Jersey) 6760

106) Senior Java Software Engineer – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) RF103P

107) Supply Chain Manager – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) T82BL

108) Senior Clinical Research Associate – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) F128KZ

109) Specialist, Quality Assurance – 6-12 Month Contract (San Francisco Bay Area) G94LT

110) Clinical Project Manager – Full Time Position (San Francisco Bay Area) Z82GN

111) Manager/Sr. Manager, Clinical Contracts and Outsourcing – Full Time Position (San Francisco Bay Area) RY111J

112) Manager/Senior Manager, Clinical Contracts – Full Time Position (San Francisco Bay Area) C111KP

113) Research Associate – Contract (~ 25 hr/wk for 6 mths or longer; San Francisco Bay Area) B999RT

114) Director / Sr Director Medical Director, Respiratory – Full Time Position (San Francisco Bay Area) Y111AE

115) Senior Medical Director, Drug Safety – Full Time Position (San Francisco Bay Area) MT114A

116) Drug Safety Scientist – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) E114AX

117) Associate Director/Director, Epidemiology – Full Time Position (San Francisco Bay Area) AR114F

118) Systems Engineering Manager – Full Time Position (New York) B126XG

119) Sr. Product Manager – Full Time Position (San Francisco Bay Area) P73AG

120) Technical Publications QC Editor – Contract (Southern California) 73K4441

121) Associate Medical Director, Respiratory – Full Time Position (San Francisco Bay Area) RT111D

122) Manager, Drug Safety Science – Full Time Position (San Francisco Bay Area) F114JX

123) Manager / Senior Manager, Drug Safety – Full Time Position (San Francisco Bay Area) H114FZ

124) Director, Drug Safety & Pharmacovigilance – Full Time Position (San Francisco Bay Area) GB114A

125) Medical Director – Full Time Position (San Francisco Bay Area) B114TN

126) Professional Discovery Research – Contract (Massachusetts) 2464

127) SCRA to (Sr) Clinical Trial Manager – Contract or Full Time (San Francisco Bay Area) R82BW

128) Sr. QA Associate/QA Manager – Full Time Position (San Francisco Bay Area) G104XB

129) Senior SCRA to Clinical Program Manager Level – Full Time Position (San Francisco Bay Area) W111HL

130) Sr. Manager Training – Full Time Position (San Francisco Bay Area) T114GR

131) Manager, Quality Assurance – Full Time Position (San Francisco Bay Area) D114QF

132) Software Quality Engineer – Full Time (Midwest) RG73B

133) Senior Clinical Research Associate – Full Time Position (San Francisco Bay Area) F114NB

134) Statistical Programmer III – Full Time Position (San Francisco Bay Area) B114NG

135) Principal Statistical Analyst/ Senior Manager, Statistical Programming – Full Time Position (San Francisco Bay Area) G114RF

136) Senior Biostatistician – Full Time Position (San Francisco Bay Area) B114MT

137) Corporate Paralegal – Full Time Position (San Francisco Bay Area) T111KX

138) Clinical Contracts Administrator / Paralegal – Full Time Position (San Francisco Bay Area) GY111P

139) Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) MT114R

140) Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) MT114R

141) Director, Statistical Programming – Full Time Position (San Francisco Bay Area) X111JP

142) IVD Systems & Verification Engineer – Full Time Position (San Francisco Bay Area) B118HZ

143) Senior QA Specialist, Manager – Contract to Full Time (San Francisco Bay Area) BK106P

144) Sr. Database Developer (Software Engineering III) – Two Full Time Positions (Midwest) G73RP

145) SCRA / Clinical Trial Manager – Contract or Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JX111Q

146) Senior Director, Healthcare Compliance – Full Time Position (San Francisco Bay Area) BR114F

147) Clinical Trial Manager / Sr Clinical Trial Manager – Full Time Position (San Francisco Bay Area) RF117Q

148) Scientist (QC) – Contract (Southern California) 2815V73

149) Clinical Project Manager – Full Time Position - 1-2 days/wk in-house (San Francisco Bay Area) ZG104M

150) Scientist II (Purification) – Contract (Southern California) 73T2809

151) Senior Statistical Programmer – Full Time Position (San Francisco Bay Area) ZA111H

152) (Sr) Manager Regulatory – Full Time Position (San Francisco Bay Area) KS132P

153) Sr. Director, Clinical Quality Assurance – Full Time Position (San Francisco Bay Area) XR96B

154) Sr. Director, Clinical Quality Assurance – Full Time Position (San Francisco Bay Area) XR96B

155) Consulting Ontologist – Contract (San Francisco Bay Area) FR103P

156) Lead CRA (in-house) – Full Time Position (San Francisco Bay Area) ZW104M

157) Senior Manager, Bioinformatics – Full Time Position (Midwest) B73FN

158) Clinical Trial Manager – Full Time Position (San Francisco Bay Area) T96NH

159) Senior Clinical Research Associate / Clinical Trial Manager – Full Time Position (San Francisco Bay Area) MJ96F

160) Regulatory Consultant – Contract (San Francisco Bay Area) P108DR

161) Sr. Staff Scientist, Translational Medicine – Full Time (Midwest) M73QL

162) Staff Scientist, Bioinformatics – Full Time (Midwest) W73BH

163) Scientist III, Bioinformatics – Full Time Position (Midwest) P73NA

164) Associate Director, Clinical Data Management – Full Time Position (San Francisco Bay Area) XT96G

165) Senior Data Manager – Full Time Position (San Francisco Bay Area) GL85B

166) IT Technical Writer – 6 month contract (San Jose Area) N96GB

167) ERP Finance / IT Analyst – Contract or Full Time Position (San Francisco Bay Area) GN96Q

168) Sr. Product Manager, Software Solutions – Full Time Position (San Francisco Bay Area) B73XS

169) Sr. Product Manager, Software – Full Time Position (San Francisco Bay Area) B73XS

170) General Warehouse Worker – Contract (Pennsylvania) 5225

171) Clinical Recruiter – Contract or Full Time Position (San Francisco Bay Area) NG104B

172) Diagnostics Product Line Business Owner – Full Time Position (San Francisco Bay Area) RC103X

173) Regional Clinical Research Associate – Full Time Position (Texas) N104BX

174) Senior Software/Scientific Quality Engineer – Full Time Position (San Francisco Bay Area) MZ103R

175) Senior Software/Scientific Quality Engineer – Full Time Position (San Francisco Bay Area) MZ103R

176) Clinical Database Programmer – Full Time Position (New York / New Jersey) M100PT

177) (Senior) Clinical Trial Manager – Full Time (San Francisco Bay Area) R96TW

178) Human Resources Assistant – Full Time (San Francisco Bay area)

179) Internal Auditor III (Finance) – Full Time Position (San Francisco Bay Area) H95TJ

180) CRAII / Senior Clinical Research Associate II (SCRA) – Contract or Full Time Position (San Francisco Bay Area) B80CR

181) Clinical Program Manager – Full Time Position (San Francisco Bay Area) R80BS

182) Biotechl Recruiter / Sourcing Specialist – (Full Time or Part-time, San Francisco Bay area preferred)

183) Clinical Laboratory Scientists (CLS)/Research Associate (RA) – Full Time Position (San Francisco Bay Area) BD64G

184) Associate Director – Full time Position (San Francisco Bay Area) Y132Q

185) R&D Software Developer Medical Technology – Full Time or Contract Position (San Francisco Bay Area) L74HT

186) Clinical Laboratory Scientists (CLS)/Research Associate (RA) – Full Time Position (San Francisco Bay Area) BD64G

187) Senior/Associate Director Program Manager – Full Time or Contract (San Francisco Bay Area) P73BY

188) R&D Software Developer Medical Technology – Full Time or Contract Position (San Francisco Bay Area) L74HT

189) Paralegal/Contracts Associate – Part Time Position 20 Hrs/week (San Francisco Bay Area) YR90W

190) Manager, Sr. Manager, Regulatory Affairs CMC – Contract or Full Time Position (San Francisco Bay Area) Q77AB

191) (Senior) Reliability Engineer Manufacturing & Production/ Industrial Manufacturing – Full Time Position (San Francisco Bay Area) S62BA

192) Senior Statistical Analyst/ Manager, Statistical Programming – Full Time Position (San Francisco Bay Area) JM96B

193) Associate Director/ Principal, Biostatistics – Full Time Position (San Francisco Bay Area) F96MP



1) Technician – Contract (New Jersey) 8224

DESCRIPTION:

  • Analytical and Technical Review
  • Data review / summary
  • Technical Database Set-up/updating
  • Reference Standards/material inventory and maintenance

EXPERIENCE AND QUALIFICATIONS:

  • MS Excel and Word
  • Ability to write and summarize simple data and reports but training will be provided on the job
  • Recent BS graduate or associates degree with classes in Science, Math and Chemistry.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

2) Associate Scientist I - R&D – Contract (San Francisco Bay Area) 73P7780

DESCRIPTION:

  • Responsible for manufacturing product(s) in a lab setting following standard operating procedures. Will utilize basic laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture products.
  • Responsible for Batch Data Records, notebooks, customer reports and work order documents.
  • Utilize specialized technical knowledge and skills to make detailed observations and analyze data to ensure within operating parameters. Advise manager of factors that may affect quality of product. Suggest options/ideas for corrective actions.
  • Maintain equipment, product inventories and related records as assigned. Note variances on manufacturing documents; audit and evaluate process documents and propose revisions. Complete, distribute and file records as required in accordance with Document Control Practices.
  • Identify potential issues in the production process; report findings to team management and members for resolution or participate in troubleshooting.
  • Complete, distribute and file records; prepare ad hoc reports as requested.
  • May perform other related duties as required and/or assigned. Successful candidate must be technically competent, capable of independent judgment as well as handling projects with some direct guidance and supervision
  • Experience working with ERP systems such as Agile, SAP a plus

EXPERIENCE AND QUALIFICATIONS:

  • Requires a minimum of 1 to 2 years of experience in the application of microbiology laboratory techniques in a manufacturing environment or research laboratory
  • Demonstrated proficiency in the use of scientific laboratory techniques, equipment and materials required.
  • Experience in the use of basic laboratory techniques, including buffer preparation desired.
  • Consistent, dependable, and accurate in carrying out responsibilities
  • Displays positive attitude toward job and others
  • Follows and provides direction accurately and efficiently
  • Excellent documentation and communication skills
  • Demonstrated ability to carry out scientific procedures and make recommendations for improvement required.
  • Good problem solving skills necessary.
  • Strong communication and excellent organizational skills a must
  • Ability to effectively cope with priority changes including timelines and project requirements
  • Capable of independent work with minimal direction or direct supervision
  • Intermediate Excel skills
  • Strong working knowledge of CAD and CAD analysis programs SolidWorks and experience with MS office suite.
  • Experience with global environments including R&D and manufacturing centers
  • Basic knowledge of artwork creation and documentation of labels
  • Experience with engineering design and analysis
  • Proficient in good engineering practices and standards
  • Bachelor's degree in Biology, Chemistry, Biochemistry or other related discipline or the equivalent knowledge and experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

3) Senior Director Clinical Development, Respiratory – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) H111BV

DESCRIPTION:

  • Plan and manage the implementation of clinical development plans required for evaluating the efficacy and safety of investigational drugs and biologics.  
  • Medical monitoring activities associated with the management and oversight of Phase II trials, leading to Phase III trials. 
  • The therapeutic areas of interest include respiratory and oncology.  
  • This position reports to the CMO
  • This position will have an Associate Medical Director as a direct report
  • Strategic clinical trial input to the clinical operations team
  • Investigator selection and evaluations
  • Evaluation of safety data from clinical trials and reports safety findings to regulatory authorities and licensing partners
  • Supports writing efforts on clinical study reports
  • Identifies and maintains liaison with leading investigators in the areas of medicine where products are being developed
  • Reports clinical study findings at professional meetings
  • Involves project teams to identify clinical indications appropriate for investigational drugs

EXPERIENCE AND QUALIFICATIONS:

  • At least 10 years of experience in drug development in the biotechnology or pharmaceutical industry; respiratory experience strongly desired
  • Experience being the Medical strategic lead on Phase 2 or later stage clinical trials.
  • Direct report management experience
  • In depth knowledge of clinical trial design, data interpretation and analysis and the ability to analyze, interpret, and report clinical trial findings
  • Effective oral and written communication skills
  • Strong interpersonal skills and ability to work effectively with project teams
  • Medical Doctor degree, board certified

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

4) Administrative / Professional - Administrative – Contract (Massachusetts) 2999

DESCRIPTION:

  • Provides administrative support
  • Handles confidential and proprietary information on a routine basis.  May provide support to other members of administrative support team.
  • Coordination and pro-active management of calendar for home office and field based employees, scheduling and coordinating meetings, appointments and travel.  
  • Manages challenging and occasionally conflicting priorities to independently complete a variety of complex administrative activities that involve confidential information and require a detailed understanding of the department and its functions.
  • Assemble data, complete routine analysis and provide preliminary recommendations for a variety of reports for senior management.  Reports may be in preparation for meetings or conferences
  • Draft correspondence and analyses, reports, tables and presentations from rough drafts.
  • Manage correspondence, inquiries from internal and external sources, meetings with internal and external vendors according to guidance and procedures.
  • Manage supplies and coordinate on-boarding and separation process with HR partners for employees
  • Manage billing and invoicing for a variety of department work orders.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent organizational and interpersonal skills.
  • Good writing and communications skills
  • Must be flexible,  proactive and detail-oriented
  • Positive attitude, team player
  • Prioritizes and executes tasks efficiently; seeking supervision when needed
  • Ability to work independently and manage specialized projects as appropriate.
  • Extensive knowledge of office software packages such as Microsoft Word, Excel, PowerPoint and Outlook

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

5) General Warehouse Worker – Contract (Pennsylvania) 7358

DESCRIPTION:

  • Support the computer and paperwork activities required for warehouse and distribution.  
  • Representing each stage of the shipment and its tracking information in the appropriate inventory management systems, from the time its leaves the facility through to delivery to the end-user
  • Filing of all paperwork as well as maintaining the Controlled GMP Filing Area
  • Other computer and paperwork activities as assigned 

EXPERIENCE AND QUALIFICATIONS:

  • Basic Computer Skills as well as good organizational skills. 
  • Must also have the proven ability to work independently, pick up tasks quickly and multi-task/prioritize workload in a dynamic, timeline driven, high volume, culturally diverse organization
  • HS diploma

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

6) Administrative Assistant II – Contract (New Jersey) 3638

DESCRIPTION:

  • Assist with scheduling meetings/teleconferences/VTC’s and finding available conference rooms
  • Managing routine calendar changes and recurring meetings and follow-up of action items
  • Assist with catering orders as needed
  • Assist with travel logistics/preparation/expense reports
  • Vacation back-up to departmental Executive Associate
  • Mailing, copying, filing, scanning, etc.
  • Miscellaneous projects as necessary
  • Occasional event planning
  • Receiving and directing visitors

EXPERIENCE AND QUALIFICATIONS:

  • Excellent organizational and interpersonal skills.
  • Good writing and communications skills
  • Must be flexible,  proactive and detail-oriented
  • Positive attitude, team player
  • Prioritizes and executes tasks efficiently; seeking supervision when needed
  • Ability to work independently and manage specialized projects as appropriate.
  • Extensive knowledge of office software packages such as Microsoft Word, Excel, PowerPoint and Outlook
  • High School Diploma and some college courses, preferred Degree
  • 7-10 yrs working experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

7) Admininistrative / Professional – HR – Contract (New Jersey) 7541

DESCRIPTION:

  • Enter talent data into e-talent tool to include but not limited to updating of key positions, succession plan charts, development groups as well as PPM matrix entry.  
  • Exporting data from the tool to quality check with community.  
  • Looking for someone with good administrative skills

EXPERIENCE AND QUALIFICATIONS:

  • Attention to detail
  • Strong data entry skills
  • Technically saavy
  • Bachelor degree preferred but not necessary.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

8) Senior Java Server Developer - Bioinformatics – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) P103LA

DESCRIPTION:


  • Looking for an experienced server-side developer who has a good eye for software architecture and API design, and a proven track record of building scalable bioinformatics / scientific software systems for big data analysis workflows in genomics and life sciences. 
  • This position will help build out the industry-leading Ingenuity genomic data analysis cloud platform for large scale scientific and clinical data analysis and management. 
  • Experience with genomics, bioinformatics and life sciences is required.
  • As a senior back end developer, you will develop software and infrastructure used to deliver the  cloud-based product line to a global community of researchers, scientists, clinicians and medical geneticists. 
  • Work closely with our scientific product leads, bioinformaticians, and front end developers on developing big data management frameworks, tooling, applications and reporting / visualizations that support large-scale, sophisticated data analysis and interpretation of genomic and genetic data. The solutions you develop will be used by molecular biologists, clinical geneticists and researchers, and biomedical informaticians, and will fundamentally enable the application of technologies for the improvement of human health.
  • A good fit would be a rock star Java developer with an aptitude for tackling complex data processing, analysis and workflow challenges in the life sciences. You will need a strong analytical mindset and a talent for executing quickly while still following best practices and who thrives on new technology and has an avid interest in bioinformatics and genomics. Use a hybrid web stack, with mostly Java on the back end but some Python and Perl as well. You will be expected to help make decisions on server-side library and framework usage, including both generic software frameworks as well as ones focused on life sciences and bioinformatics, as well as scaling our distributed computing cloud configuration supporting large scale data management and processing for our customers around the world.

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s or Master’s Degree in Bioinformatics, Computational Science, Biological Life Science
  • 5+ years of recent Java development experience – this is a primary requirement.
  • 5+ years’ working experience involving Bioinformatics software bioinformatics tools and biological databases
  • 3+ years’ experience building NGS pipelines for processing human sequencing data from at least Illumina and Ion Torrent platforms
  • 3+ years working in a team-based agile development environment
  • Familiarity with Linux required, experience with Python and Bash scripting preferred
  • Understanding of Next Generation Sequencing technique and expertise with NGS bioinformatics tools such as GATK, Bowtie, etc
  • PhD in Bioinformatics or Computational Science preferred
  • 8+ years bioinformatics development experience in a research or translational setting
  • Experience working with both DNA-Seq and RNA-Seq data
  • Experience with commercial and open source NGS pipeline infrastructure tooling and cloud infrastructure like Amazon Web Services, Heroku, etc
  • Strong experience with Python language and libraries; 3+ years applying Python scripting to bioinformatics preferred
  • Strong communication skills and willingness to ask a question. We do not typically assign 100% specced-out tasks that always must be implemented an exact way; you'll be given a business problem to solve for the user, and expected to understand and explore the space of design alternatives to come up with a good solution, using rapid prototyping to test your design hypotheses. Questions will occur and it is important that you be comfortable asking them and chasing down answers.
  • Know how to optimizing complex distributed software systems in a cloud deployed environment.
  • Strong believer in version control tooling and know your way around git and Github.
  • Resourceful and can pull down a Java or Python project and get running on development the same day.
  • Like working with teams on large apps where modularity, performance, flexibility, maintainability, and API integration are fundamental concepts that inform your code and architecture decisions.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

9) Senior Scientist – Analytical Chemistry – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A106JY

DESCRIPTION:

  • Develops, plans and executes analytical chemistry activities for the company in compliance with cGMP, safety and regulatory requirements.
  • Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems.
  • Conducts drug release rate and assay/impurities testing of long term/sustained release drug formulation.
  • Develops, trouble shoots and improves analytical methods and validation reports in support of regulatory submissions.
  • Takes the analytical lead on large portions of assigned projects, identifying and performing the required analytical tasks with minimum supervision in support of product development, lot release, and regulatory submission activities.
  • Participates in method transfer activities.
  • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.  
  • Defines complex problems, develops approach and develops experiments with sound judgment.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with Agilent HPLC and data acquisition software is required.
  • Knowledge of current FDA/ICH guidelines and US Pharmacopeia is required.
  • Understanding and familiarity with analytical regulatory requirements for ANDA/NDA submission is preferred.
  • Must possess ability to work on multiple tasks in a fast paced environment.
  • Excellent hands-on laboratory skills.
  • Highly motivated & flexible team player.
  • Excellent written and verbal communications skills. 
  • Must be able to compose sound written work with no assistance.  
  • Experience in writing regulatory documents.
  • Skilled at presenting technical information to non-technical audiences.
  • Possesses sound judgment skills.
  • Expert knowledge of scientific principles and concepts.   
  • Requires an MS in a scientific discipline or equivalent with a minimum of 5 years of experience in a pharmaceutical product research, development and and manufacturing environment

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

10) Senior Front End Developer for Bioinformatics – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) FB103T

DESCRIPTION:

  • Will lead front end development on the DataStream tools used to deliver the entire company product line to the customers, and to integrate products and platform technology into a wide range of scientific workflows across academia, pharma, biotech and clinical settings. 
  • Will work closely with the scientific product leads, bioinformaticians, and back end developers on developing tools and visualizations that support large-scale, sophisticated data analysis and interpretation. 
  • The solutions you develop will be used by molecular biologists, clinical geneticists and researchers, and biomedical informaticians, and will fundamentally enable the application of company technologies for the improvement of human health.
  • A good fit would be a developer who can execute quickly while still following best practices and who thrives on new technology and has an avid interest in bioinformatics and genomics. Using a hybrid web stack, with mostly Java on the back end but some Python and Perl as well. 
  • Expected to help make decisions on front-end library usage, front-end and javascript architecture, and lead implementation of CSS, HTML and JS. Help evaluate and select modern tooling (such as SASS, Coffeescript, Grunt) and selectively apply techniques in the space (such as Raphael, D3, Backbone). 
  • Talented front-end developer who writes clean, well-organized CSS and HTML and composes Javascript beyond the walled garden of JQuery.

EXPERIENCE AND QUALIFICATIONS:

  • A bioinformatics degree is not required for this position, but experience building web-based user interfaces or information visualizations for biomedical researchers, scientists and clinicians is a must.
  • Exceptional HTML5, CSS and JavaScript skills, JKQuery
  • Experience working with Java backends a must; Java software development experience strongly preferred.
  • MVC, SVN, Linux command line
  • Demonstrated ability to quickly and independently implement MVC sites using Bootstrap or similar frameworks.
  • Strong attention to detail and visual design -- please expect to show your portfolio
  • Bonus: experience with CoffeeScript, SASS, Django and similar
  • Bonus: experience with JS app and visualization frameworks: EmberJS, Angular, Backbone, D3
  • Strong experience with MVC client-side libraries, having done one or more substantial projects with a framework such as Backbone or Ember.
  • Experience : built web applications that involve multiple user roles working together in a multi-step workflow
  • Have demonstrated design skills for rich data-driven web apps
  • Projects to identify what’s missing or unworkable in a wireframe or high-level set of design requirements, and have the basic design and UX chops to improvise when necessary.
  • Strong communication skills and willingness to ask a question. 
  • Expected to understand and explore the space of design alternatives to come up with a good solution, using rapid prototyping to test your design hypotheses. 
  • Know how to optimizing website resources and front-end performance for data-heavy Javascript apps
  • Should be comfortable and effective using SASS (or LESS, Stylus, etc.) and know your way around Grunt, Bower, etc. Coffeescript tolerance is a plus.
  • Well-versed in the classic front end skills as well - you know your meta tags, SEO basics, and analytics / user tracking, and can deal with IE8 etc. should the unfortunate necessity arise.
  • Version control tooling and know your way around git and Github.
  • Resourceful and can pull down a PHP or Ruby project and get running on development the same day.
  • Like working with teams on large apps where performance, responsive design and API integration are fundamental concepts that inform your code and architecture decisions.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

11) Director / Executive Director, Regulatory Affairs – Full Time (Boston Area) GR110B

DESCRIPTION:


  • Responsible for developing innovative global regulatory  strategies  for  program  and  leading  the  preparation,  submission  and approval  of marketing applications. 
  • Responsible for managing interactions with health authorities and for ensuring that regulatory documents are in compliance with health authority regulations.
  • Develop and implement creative regulatory strategies aimed at achieving marketing authorization and appropriate product labeling. Ensure cross functional alignment on regulatory plans and strategies
  • Responsible for the timely production and submission of regulatory documentation, including investigational and marketing applications (IND, CTA, NDA, MAA etc.) in compliance with global regulatory agency requirements
  • Serve as primary liaison with regulatory authorities, including overseeing the writing of pre-meeting briefing materials, leading the preparation for meetings with regulatory agencies, and ensuring appropriate follow-up
  • Review Clinical study protocols, Clinical study reports, Investigator brochures, safety reports, Annual reports, CMC reports and regulatory submissions
  • Maintain regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree in a scientific discipline, Advanced degree (PhD, MS) preferred)
  • 7+ years of pharmaceutical industry experience required. At least 4 years of regulatory affairs with experience associated with global submissions.
  • Must have comprehensive understanding of global regulatory requirements for registration, development and approval of investigational products
  • Excellent knowledge of global regulatory requirements and processes and filing experience (IND, CTA/NDA/MAA)
  • Strong interpersonal, communication, and leadership skills
  • Ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
  • Demonstrated leadership and people management skills in team and departmental settings
  • Excellent organizational, prioritization and planning skills. Ability to work independently on projects and initiatives internally and with external vendors

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

12) Non Promotional Program Specialist – Contract (New Jersey) 2537

DESCRIPTION:

  • Work with the manager of Non Promotional Programs to oversee processing of all non-promotional events: this includes interaction with non US affiliates where US HCPs and HCOs are contracted with.  
  • In conjunction with the manager of non-promotional programs, the specialist will executing training and communications of best working practice to user groups across the enterprise.
  • Make recommendations on necessary process improvements and/or changes
  • Execution of training and communications plans to businesses for rationale and process in new and emerging areas
  • Collaborate with business owners to resolve individual and complex cases
  • Monitor compliance and clarify policies for user groups 

EXPERIENCE AND QUALIFICATIONS:

  • Understand business processes
  • Analytical skills
  • Detail / accuracy orientation
  • Collaboration
  • Strong written and verbal communication skills
  • Excellent organization skills
  • Demonstrated experience working in a matrix environment
  • Demonstrated experience working with client groups 
  • Demonstrated results in prior roles
  • Bachelor’s Degree required
  • Minimum of 3 years of relatable experience in a pharmaceutical environment 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

13) Sr. Director, Clinical Regulatory Affairs – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) EH113K

DESCRIPTION:

Summary:

Directs the clinical and nonclinical aspects of the global development of early and late-stage drug candidates, both biologics and small molecules, providing strategic direction and senior-level regulatory expertise.  Oversees and mentors multiple direct reports to achieve regulatory objectives in line with corporate goals.  Ensures positive interactions with corporate partners.  Leads due diligence, regulatory intelligence, and regulatory affairs initiatives.  Supports development and implementation of department policies.

Responsibilities:

  • Defines the clinical and nonclinical regulatory strategy supporting efficient drug development for early and late-stage products
  • Oversees planning, preparation, and submission of clinical trial applications and marketing applications in the US and internationally
  • Oversees maintenance of approved products and supports global commercialization of these products
  • Oversees all clinical and nonclinical interactions with global regulatory authorities
  • Manages and mentors multiple direct reports
  • Supports executive team on due diligence, regulatory intelligence, and regulatory affairs initiatives
  • Serves on senior staff committee responsible for developing and implementing department policies

EXPERIENCE AND QUALIFICATIONS:

  • Prior oncology experience is preferred. 
  • Rare disease experience is a plus.
  • Prior experience in filing marketing applications, obtaining approvals, and maintaining the licenses for drugs and/or biologics
  • Skilled at gathering regulatory intelligence and developing product approval strategies
  • Excellent skills in managing multiple regulatory affairs professionals
  • Proven ability to successfully interact with regulatory authorities
  • Prior experience in filing global marketing applications and with advertising and promotion regulations is desirable
  • Prior experience with both biologics and small molecules is desirable
  • At least 12 years of experience in Regulatory Affairs in the biotechnology or at least 8 years of experience in managing regulatory staff
  • Minimum of B.S. degree in life sciences or equivalent; advanced degree preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

14) Administrative / Professional - Professional – Contract (New Jersey) 2662

DESCRIPTION:

  • Fully manage transactional activities for low value, low risk and non repetitive purchases under a given threshold
  • Ensure compliance with local contract approval policies and spend management strategies;  function as process path gatekeeper
  • Review all purchase requisitions for data entry for accuracy and compliance
  • Responsible for the correction of any transmission errors of the purchase order
  • Responsible for compliance with each step of the local procurement process and policies
  • Perform SOX controls
  • Assist end users with data entry, completion of the purchase requisitions, and purchase order revisions
  • Interact with suppliers in case of issues related to the receiving of goods and services (quantity, quality and late delivery management) and communicate with sourcing (feedback)
  • Interact with accounts payable regarding any purchase order issues with payment of the invoice
  • Perform monthly Purchase Card Order reconciliation / Ensure Amex payment terms are met
  • Issue and dispute resolution
  • SOX Documentation filing requirements
  • AP / Controller requests
  • Procurement policies and best practices
  • Interface as needed with internal customers, suppliers, buyers, department in charge of technical support for SAP/NEXTS (if applicable), finance department, accounting department
  • Create and manage Contract Workspace contents and tasks in NEXTS including entering of pricing terms from sourcing events, selecting appropriate templates, following policies and procedures in determining the routing of contracts, facilitate the contract approval process and work with business owner to facilitate contract execution
  • Monitors the progress of contracts through the contract process and all phases through contract completion
  • Manage all contract publishing process including scanning retrieval and uploading of executed contracts into NEXTS and communicates PO reference number to internal and external customersEnsure compliance with several different local contract approval policies and spend management strategies; function as process path gatekeeper and reviews all contract requests against local Contract Approval Policies
  • Maintain the accuracy and consistency of contract information
  • Performs SOX controls (review Contract Approval Policy, Delegation of Authority of contract signatories and compliance with records retention policies), and support compliance with CIA as needed
  • Assist/support buyers upon request for sourcing activities to perform RFP transactional tasks when appropriate including data entry , documentation support, and project close out activities

EXPERIENCE AND QUALIFICATIONS:

  • Excellent understanding of Procure to Pay process including financial, accounts payables and procurement process and systems (SAP, Ariba)
  • Solves and works independently and with team to solve complex problems
  • Ability to be work efficiently under pressure with little supervision, deliver high level of customer service and proven track record of following through with assignments meeting strict deadlines
  • Ability to adapt and drive change, begins new tasks, assumes responsibility and makes decisions in line with process assessment
  • Proper set up ofPO’s to facilitate accounting, tax, & other requirements
  • Understanding of contracts and business, legal & financial terms and conditions including business specific requirements (i.e. tax, language, government, etc.)
  • Qualified candidate should possess excellent organizational skills and a systematic approach to work with care taken over detail and due regard to confidentiality
  • Must possess efficient analytical skills;  attention to detail, diligently follow up on many items that are simultaneously in various stages of completion
  • Plans, prioritizes, organizes and completes work to meet established objectives
  • Ability to prioritize and manage multiple projects simultaneously
  • Must a be a self-starter - have a high degree of personal initiative
  • Strong interpersonal skills
  • 3 years plus of work experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

15) Scientist (BS or MS) – Contract (Pennsylvania) 8672

DESCRIPTION:

  • Candidate will be a member of the Manufacturing Technology – Manufacturing 
  • Assist team providing inline technical support of viral vaccine manufacturing.  The basic functions of this position will be to work independently or as part of a project team to provide process technical support for the production processes.  This support will include planning, designing, and implementation of short term technical projects as well as providing independent troubleshooting of non-conforming process events.  
  • Project work may involve technical leadership and ownership of assigned area of responsibility, development and implementation of process improvements.
  • Project work must be conducted with minimal oversight from the area technical lead, and requires successful application of scientific problem solving skills.  
  • The candidate will also be required to obtain a basic working knowledge of company-specific systems, standards, and procedures. 
  • Periodic checks and reports are required to review soundness of technical judgment and the status/schedule of the effort.

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated interpersonal skill, including flexibility and ability to work in a team environment.  
  • Proven analytical abilities.  
  • Demonstrated written and verbal communication skills.
  • Experience in Vaccine, Biologic, or Pharmaceutical manufacturing or providing technical support of such processes. 
  • Ability to work both independently and as part of a project team collaborating with members from Manufacturing/Operations, Manufacturing Technology, Validation, Automation and Quality.
  • Demonstrated technical problem-solving, communication and collaboration skills.
  • Demonstrated organization skills, ability to multitask, and work in a dynamic environment
  • BS/MS Biology, Chemistry, Engineering or Life Sciences

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

16) Recruiter – Contract (Pennsylvania) 4494

DESCRIPTION:

  • The Recruiter will focus on manufacturing related positions. 
  • Responsible for partnering with the organizations they support 
  • Ownership/accountability for all openings in client family.  
  • Educate client groups on recruiting/staffing processes. 
  • Document/track recruiting activities in system. 
  • Coach managers on the selection process. 
  • Source, screen and interview candidates.

EXPERIENCE AND QUALIFICATIONS:

  • Must be self-motivated, present well and be able to develop relationships with both managers and candidates. 
  • Ability to navigate through change and demonstrate flexibility as organizational needs shift. 
  • 5+ years of solid recruiting experience. 
  • Must develop and implement creative sourcing strategies to identify talent.
  • Bachelor degree preferred with minimum of 5 years relevant experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

17) Data Entry Specialist – Contract (Massachusetts) 9190

DESCRIPTION:

  • Responsible for accurate entry of patient information into department database for individual and multiple patient assistance applications and insurance verifications
  • Triage all incoming faxes and workload via Microsoft Outlook  to ensure all patient assistance and verification requests are entered into the database and distributed appropriately
  • Process patient assistance applications and communicate results to healthcare providers
  • Troubleshoot and resolve reimbursement related issues with the team members and insurance companies
  • Maintain a proficient understanding of the Medicare Part D Benefit, Medicaid, and Commercial prescription drug plan benefits

EXPERIENCE AND QUALIFICATIONS:

  • Spreadsheet and database skills.
  • Accuracy and Speed are important.
  • Proficient typing skills.
  • Preferred basic understanding of health insurance benefits and reimbursement.  
  • Must be able to multitask and learn reimbursement related concepts quickly preferred.  
  • Must have excellent communication skills and ability to thrive in a team environment. 
  • Bachelor or Associate’s Degree preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

18) Records Manager – Contract (Pennsylvania) 4610

DESCRIPTION:

  • Manages Trial Master File documents for the trials in accordance with internal processes and all applicable regulations.
  • Reviews the quality and the indexing of each document submitted to the TMF by the contributors.
  • Accepts or rejects documents submitted to the TMF following the TMF Review Criteria.
  • Conducts the Document QC of the TMF at key study milestones.
  • Provides TMF Status Reports to the Records Manager and alerts him/her of recurrent or specific issues which occur during a trial.
  • Supports TMF Contributors on Document Management Processes and the use of the Electronic Document Management System.

EXPERIENCE AND QUALIFICATIONS:

  • Organization skills
  • Computer skills (Electronic Document Management System, Microsoft Office)
  • Customer Orientation
  • Ability to work in a team
  • Associate’s degree or High School diploma with 5 years of experience in Clinical Research
  • Knowledge of the Clinical Development process
  • Knowledge of the TMF regulations, ICH, GCP, etc..
  • Ideally, previous experience as a Clinical Trial Assistant.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

19) EHS Coordinator – Contract (Southern California) 1461D73

DESCRIPTION:

  • Assist in development of training programs
  • Assist in the implementation of EHS programs for chemical handling, biosafety, hazardous waste, electrical safety, industrial hygiene, radiation, lasers and facilities maintenance programs.
  • Assist in the management of safety committees.
  • Assist with the site emergency response team.
  • Track site environmental, health and safety metrics
  • Assist in the maintenance of the incident management database
  • Assist in the updates to the EHS inspection program and tracking corrective actions 

EXPERIENCE AND QUALIFICATIONS:

  • Requires minimum of a Bachelor’s degree and 3 years of experience in an environmental, health and safety related discipline and technical/practical knowledge of EHS regulations, codes and guidelines.  
  • Experience in OSHA’s VPP is strongly preferred.  
  • Requires a bachelor’s degree in safety engineering, environmental or industrial hygiene or comparable field; or the equivalent knowledge and experience.  
  • Must have working knowledge of federal and local EHS regulations, including OSHA and EPA. 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

20) Manager, Clinical Operations, Oncology – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) HL113W

DESCRIPTION:

Summary:

Responsible for managing operational activities of assigned clinical programs. Provides a level of expertise, aligned with the principles and standard practices for operational activities of clinical trials. Act as the lead for assigned projects and provide regional insight to global projects where applicable. Responsible for CRO training, management and agreements related to CRO clinical activities. Partner with key stakeholders internal and external to ensure continuous harmonized operations of global activities and to maintain high standards for functioning in a matrix environment.

Responsibilities:
  • Responsible for representing Operations on cross-functional study teams and vendor, CRO operational meetings and ensuring compliance with global operational standards and procedures
  • Manages cross-functional study teams and vendor operational meetings to ensure compliance with  operational responsibilities
  • Provide leadership for Operations related issues and advise management team of potential issues and solutions
  • Manage, coach and develop junior staff in order to maximize their capability and contribution to provide high quality deliverables
  • Responsible for the review and oversight of  responsibilities in study data management plans for  operations and operational responsibilities associated with all clinical trials
  • Responsible for ensuring that all  components of the trial master file are up to date and accurate for assigned investigational trials
  • Monitor global regulatory intelligence for global industry practices for operational efficiency and compliance
  • Responsible for operational guidance for investigators and provide CRO training related to  the study conduct
  • Responsible for managing  queries for clinical studies from CROs
  • Participate in the conduct of audits and Inspections related to Operations
  • Address consistency in collection, processing and evaluation of clinical data, contribute to the development of global SOPs and policies to ensure compliance with regional regulatory requirements and to drive improvements in global processes
  • Represent Clinical Operations on global teams as an operation owner and/or function as a vendor relationship manager for vendors
  • Support sponsored clinical trials and development program

EXPERIENCE AND QUALIFICATIONS:

  • Previous experience working in global environment
  • History of successfully developing effective relationships with outside vendors and CROs
  • Outstanding verbal communication skills which resulted in professionally communicating and guiding individual and team efforts related to Clinical Operations
  • Demonstrated skills in negotiation, multi-tasking, organization and decision making
  • Proficiency in databases, coding and data mining methodologies we well as Microsoft applications
  • Ability to travel to global sites required.
  • Prior experience working on cross-functional teams in a lead capacity
  • Minimum of 4 years oncology clinical trial experience
  • Minimum 5years experience in Clinical Operations: working with CROs and other vendors
  • At least 5 years of management experience in a clinical research environment
  • A Bachelor of Science / Masters prefer

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

21) Senior Clinical Research Associate – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GT113P

DESCRIPTION:

  • Participates in the planning, management and execution of clinical studies, with a strong focus on data quality, risk mitigation, enrollment, investigator/site relationships, and general project oversight in compliance with Regulatory Authorities’ regulations/guidelines andStandard Operating Procedures and Work Instructions.
  • May lead cross-functional study team(s) and/or sub-team(s)
  • Prepares content for training materials and coordinates training on study procedures
  • Prepares operational plans and defines study-specific working practices
  • Contributes to the development study execution plans and risk management plans
  • Develops, manages, and maintains relationships with external partners
  • Serves as study manager for the functional area in managing protocol execution
  • With input from therapeutic area Development Sciences Team, contributes to the development of study documents including protocols, informed consent forms, and study manuals
  • Oversees setup and management of the CTMS and TMF
  • Participates in country and site selection
  • May manage feasibility studies
  • Reviews feasibility data
  • Liaises with vendors to ensure quality site selection
  • Participates in preparation of RFP assumptions and SOW
  • Contributes and reviews specs for affiliated vendors (IVRS, labs)
  • Oversees all aspects of clinical vendor management (performance, quality, timelines, deliverables, etc.)
  • Provides input, reviews, and approves vendor study specifications
  • Ensures appropriate escalation of issues in timely and efficient manner
  • Participates in design and approval of various project and communication plans
  • Reviews essential regulatory documents
  • Prepares, reviews, approves and assures adherence to Monitoring Plan
  • Reviews eCRF specs (EDC), CRF completion guidelines and Data Management documents, as needed
  • Contributes to the development and review of Clinical Data Review Plan
  • Designs, reviews and approves study tools (for investigative site use)
  • Plans/organizes/leads investigator meetings
  • Contributes to the preparation and review of materials for Investigator Meetings and CRA training
  • May provide oversight of country regulatory approvals (e.g. CTA, MoH) and country/site IRB/EC approval
  • Reviews regulatory packages (essential documents - blank forms and templates for 1572s, financial disclosure, etc.),
  • Authorizes investigational product shipment to investigational sites
  • Reviews and approves informed consent forms (e.g. site or country specific ICFs)​
  • Ensures enrollment is tracked and recorded appropriately
  • Contributes to the development and maintenance of recruitment strategy
  • Addresses enrollment and retention issues
  • Provides oversight of clinical monitoring to ensure quality data (in-sourced or out-sourced),
  • Reviews monitoring trip reports to demonstrate oversight
  • Reviews study data as defined by Study Team
  • Follows up on trending outstanding eCRFs and data queries
  • Performs oversight and co-monitoring visits to ensure data integrity
  • Oversees resolution of study conduct issues
  • Ensures ongoing reconciliation of TMF
  • Monitors GCP/ICH site level compliance
  • Manages/oversees study and vendor close out activities
  • Oversees the completion of all archiving and final TMF reconciliation and transfers as required

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree in biological science preferred.
  • Combination of educational and work experience providing competencies to perform the required accountabilities specific to position
  • 4-6 years industry experience, including a minimum 4 years clinical research experience with 3 years experience working with solid tumors:
  • Possesses record of strong therapeutic experience
  • Ability to relate to and discuss disease and treatment process
  • Can demonstrate core knowledge of RECIST and stand of care within disease area.
  • Line management and/or mentoring experience of Jr. CRAs and Clinical Assistants:
  • Mature monitoring/mentoring skills expressed by calm and thorough review of situations. Proactively identifies and/or addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolution.
  • Exhibits significant positive participation:
  • Takes direction well
  • Possesses the ability to define and meet requirements
  • Displays flexibility for improvement and creating solutions.
  • Demonstrates high proficiency and extensive experience managing large scale vendors (CRO, Central Laboratories, IXRS, etc.)  in a global environment
  • Ability to function independently, take initiative and collaborate in process improvement activities and teams
  • Ability to constructively influence the decision making process
  • Timely escalation of issues with solution based approach
  • Adequate identification of key stakeholders and decision makers throughout
  • Demonstrates, by example, proactive problem solving abilities and follow through
  • Exhibits proficiency in all aspects of monitoring, co-monitoring, teaching, and training
  • Strong experience with EDC and upfront data quality implementation procedures specific to the protocol under study
  • Understanding of the clinical development plan and how the individual projects are impacted
  • Ability to travel is required
  • Displays strong written and verbal communication skills
  • Proficient with Microsoft Office Suite Software

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

22) Scientist II / Senior Scientist Pharmacokinetics/Pharmacodynamics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) F113KV

DESCRIPTION:

Summary:

Responsible for the design, execution, interpretation and reporting of clinical pharmacology and clinical/nonclinical pharmacokinetic/pharmacodynamic (PK/PD) studies. This includes the assessment of PK/PD relationships of recombinant protein and small molecule drug candidates that are situated throughout all stages of development  (Phase 0-IV).  The individual will assess and recommend dose levels and regimens for molecules in Phase 0-IV clinical development (including new indications for existing therapeutics) by working in close partnership with medical directors, clinical scientists, biostatisticians, bioanalytical research scientists, pharmacologists and toxicologists, , formulation and process scientists, and project teams. This assessment will require modeling, simulations and predictions of PK and PD, and make recommendations on dose regimen for drug candidates in clinical development.  Population PK/PD and exposure-response analysis of drug candidates will be conducted as the programs progresses in clinical development..   The individual will be responsible for the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to internal cross-functional teams, external collaborators, US and ex-US regulatory authorities and the scientific community.    

Responsibilities:
  • Design and interpret PK/PD studies in support of molecules in clinical and nonclinical development.
  • Model, simulate and predict nonclinical and clinical data to drive decisions on dose and frequency of dosing
  • Perform population PK analyses on drug candidates as they progress through clinical development
  • Provide expert PK/PD advice to cross-function project teams
  • Interact with pharmacologists, toxicologists, medical directors and regulatory affairs personnel for the timely completion of clinical and nonclinical studies and regulatory filings.
  • Represent the Pharmacological Sciences Department on multi-disciplinary drug development teams and lead departmental sub-teams.
  • Interact with external collaborators, multi-company project teams regarding and outside contractors
  • Write reports, sections to INDs, NDAs, etc. and publish findings at the appropriate time

EXPERIENCE AND QUALIFICATIONS:

  • Desire to work in a position focused specifically on modelling and pharmacokinetics
  • Strong background in quantitative clinical pharmacology analysis, pharmacokinetics and/or statistics with extensive knowledge of drug development process
  • Hands-on experience with population PK/PD and exposure-response analysis using NONMEM/R/SPLUS software in clinical drug development
  • Hands-on experience with non-compartmental and compartmental PK/PD analysis using WinNonlin
  • Excellent writing and verbal communication skills both cross-functionally as well as outside to various regulatory agencies.
  • Hands-on experience with preparing clinical pharmacology/PK/PD related sections in regulatory submissions (i.e., IB, IND, NDA, MAA, BLA) preferred.
  • Clinical pharmacology and clinical/nonclinical PK/PD study design, implementation and interpretation; experience in modeling and simulation
  • Experience with GLP procedures and documentation or equivalent familiarity with FDA guidance’s.
  • In vitro/in vivo ADME experience preferred
  • Pharmacokinetic experience with biologics and the associated immunogenicity issues is a plus.
  • At least 2 years experience for Scientist II or 5 years for Sr. Scientist of industry experience.
  • Ph.D. in a pharmaceutical science, bioengineering or related field.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

23) Research Associate 1 – 6 Month Contract (San Jose Area) A132FV

DESCRIPTION:


  • Responsible for execution of in vitro and in vivo experiments, including tissue culture, apoptosis assays, biological assays, western blotting, molecular biology and animal tumor models and generally supporting preclinical project teams in screening new compounds in cellular assays.
  • Tissue culture biological assays, molecular biology, western blotting, spectrophotometry and microscopy. Small animal tumor models. 
  • Development/execution of in vitro and ex vivo cell based assays with hematopoietic cells
  • Clinical immune-monitoring with multi-color flow cytometry methods
  • Development/execution of ex vivo PD assays
  • Monitor and order lab supplies and maintain equipment. 
  • Provide support for scientific staff.
  • Monitor and order lab supplies and maintain laboratory in functional order.
  • Responsible for presenting data in group meeting
  • Maintain records of experiments and assist with laboratory operations

EXPERIENCE AND QUALIFICATIONS:

  • Excellent written and verbal communication skills.  
  • Ability to solve problems and work in a group environment. 
  • Advanced organization skills and attention to detail skills.
  • Must have hands-on expertise in: flow cytometry (FACS), in vitro cell-based assays, molecular biology techniques, including Western blotting, ELISA, QPCR and mammalian cell culture.
  • Must be knowledgeable of use of analytical software and equipment for these methodologies.
  • Expertise in isolation of human cells and establishment of primary cell cultures is an advantage.
  • Must have excellent oral and written communication skills, must be self-motivated, highly organized, and able to work independently in a fast-paced research environment.
  • Prior industry experience is a plus.
  • 2-5 years experience with the execution of in vitro and in vivo experiments, including tissue culture, apoptosis assays, biological assays, western blotting, molecular biology and animal tumor models. 
  • BS/MS in related scientific in Biochemistry, Immunology, Cancer Biology or a related discipline.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

24) Associate Director, Project Management – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BL140Y

DESCRIPTION:

Summary:

A team leader who will be an influential individual within our organization, responsible for providing project management planning and guidance to support in market (commercialized)  and late clinical development stage programs. This individual will be a key member of project teams, working closely with Project Leaders, team members from multiple functions including Marketing, Sales, Medical Affairs, Business Development, Manufacturing, Regulatory and Financial Planning and Analysis as well as senior management. For partnered programs, this individual may be required to assume alliance management responsibility in addition to providing Project Management support.

Responsibilities:        
  • Planning – Ensure team objectives are clearly established and communicated. Create and maintain project plans and timelines, organize and conduct project team meetings as required. In combination with project leaders, ensure that project objectives are clearly established and agreed with the project team and management. Monitor the progress of project teams and update/adapt project plans as necessary.
  • Financial planning – partner with Finance to define project activities/timelines to drive quarterly forecasting and annual budget planning rounds.
  • Risk Analysis and Problem Solving – identify risks, opportunities, issues and constraints. Plan risk mitigating activities and facilitate resolution of issues and corrective actions as necessary.
  • Resource Utilization – Ensure that adequate resources are available and effectively allocated for maximum efficiency and productivity, highlight resource constraints/shortages to management.
  • Communication – Ensure that management is kept apprised of team achievements and progress against plans. Regularly communicate project status including expectations, opportunities and risks. Reporting will occur via regular written communication as well as organized presentations, discussions and informal interactions with management and stakeholders.
  • Organizational Development - Identify and lead opportunities for business process design and improvements.

EXPERIENCE AND QUALIFICATIONS:

  • In-depth operational and strategic understanding of pharmaceutical research and early development projects gained through active project experience.
  • A track record of successful leadership roles in pharmaceutical projects either through formal leadership positions or across a matrix.
  • Demonstrated ability to work in teams, build strong relationships and influence across functions.
  • Very strong written and oral communication skills. (Candidates may be asked to deliver a presentation as a part of the interview process.)
  • Very strong planning skills. 
  • Familiarity with planning and visualization tools such as MS Project is desired.
  • Advanced degree in life sciences or business (or equivalent industrial experience).
  • High energy level, personal productivity, creativity and commitment. 
  • Able to provide mentorship to junior staff as necessary; no direct reports

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

25) Operations Project & Budget Coordinator – Contract (New Jersey) 0002

DESCRIPTION:

  • Monitor resource use and spending on an ongoing basis. Develop a strong relationship with administrative staff to ensure proper access of records, tools and able to troubleshot and address issues. Interface with project leads monthly to monitor progress of financial activity vs plan (includes start and end dates, accruals and variance to plan)
  • Help develop and implement new operational processes and tools. Example: Quality Management and Performance Management System (processes, metrics, goals\standards and tools)
  • Assist with the development of work flows, training, follow-up and troubleshoot and develop solutions to operations issues  
  • Help coordinate activities (meetings, including coordinating calendars, preparation materials and agenda, developing and circulating meeting minutes as needed and follow-up on open task and issues) 
  • Provide technical support and liaison to users for financial and administrative matters and tools, working closely with the administrative staff as well as operation team
  • Interface with procurement, legal and finance locally (as appropriate) and NEXT system administrators to help facilitate AED and agreement submissions through outsourcing, contracting and approval system. Track submissions and approvals, ensuring and validating proper budget allocations and helping to troubleshoot and facility resolution of issues 
  • Will work closely with operation staff to align / simplify processes and tools dedicated to administrative management of projects / activities and train administrative staff
  • Help to organize and administer departmental dedicated e-Room and SharePoint space   

EXPERIENCE AND QUALIFICATIONS:

  • Candidate will have a BS or BA, an MBA is preferred
  • At least 3 to 5 years of experience in the pharmaceutical or healthcare industry directly managing departmental processes, training and financial budgets 
  • Strong planning, tracking and interpersonal skills. 
  • Well-organized, results oriented and capable of managing multiple projects with respect to priorities, self-driven and self-management
  • Exceptional skills and experience with Microsoft Office (primarily Visio and Excel)  
  • A strong working knowledge of business processes, including strategic planning, budget management and work flow development is a must
  • Must possess exceptional communication skills, both oral and written, excellent organizational time management skills, and the ability to collaborate and align with diverse teams across geographical locations

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

26) Biostatistician – Contract (New Jersey) 9129

DESCRIPTION:

  • Develop and implement in silico methods for analysis of human immunological and biological sequence data derived from large scale sequencing of antibody heavy and light chains from vaccinated individuals.  
  • Coupled with immunological readouts and associated metadata, looking to address questions involving the induction and dynamics of B-cell repertoires, antibody induction and maturation, lineage, and functionality in response to vaccination. 
  • Integration and mining of immunological readouts, associated metadata and biological sequence data to facilitate phylogenetic, sequence and structural analyses and identify significant correlations and patterns in the data,
  • Review relevant literature and seek out advances in computational techniques for in-house  implementation,
  • Prepare research reports and other documentation as needed, sharing information with project teams within agreed timeframes

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge requirements include a foundational understanding b B-cells, antibodies, bioinformatics and statistical sequence analysis, including phylogenetics.
  • Ability to develop statistical algorithms based in any of R, Perl, Python or other common programming language.
  • Experience in the use of parallel processing and multi-node computing would be an asset
  • Experience in the development of web-based user interfaces to facilitate the execution and visualization of simple queries would be an asset
  • MSc (with minimum of 2 years experience) or PhD in Biostatistics, Bioinformatics, Computational Biology or related field with a background in clinical science, infectious disease or immunology being an asset)

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

27) Administrative / Professional - Professional – Contract (New Jersey) 7253

DESCRIPTION:

  • Provide administrative and project support for the VP, and corporate teams
  • Assist with projects/situations arise
  • Ability to work independently and manage specialized projects as appropriate
  • Assist with travel arrangements and meeting planning, including numerous teleconferences
  • Assist in the structure of calendar agenda and follow-up of action items

EXPERIENCE AND QUALIFICATIONS:

  • Extremely detail orientated with a collaborative team spirit and a strong service orientation
  • Good writing and communications skills are important including PowerPoint skills.  
  • A demonstrated commitment to social responsibility and volunteerism is desirable.
  • High school diploma or equivalent required. College a plus

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

28) Director / Sr Director, International Operations – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) G127KM

DESCRIPTION:

The Senior Director, International Operations will develop and execute early access programs.  The role reports in to the Vice President, Commercial Development.  This opportunity includes all activities related to facilitating drug access prior to commercialization efforts, registration, and/or broad product availability.

Responsibilities:
  • Establishing early operations and in-country support for NPP (Named Patient Programs)
  • Lead the efforts of a matrix team toward providing access to patients
  • Ensure expeditious product release in each market
  • Design, document and implement required NPP processes
  • Coordinate due-diligence efforts across all functions including other Commercial managers,  PV, Manufacturing, Compliance, Quality, Legal, Finance, Medical and Regulatory
  • Identify, select and contract with local partners and local consultants
  • Coordinate training for all external parties, including but not limited to product, disease, market access and adherence programs
  • Manage partners
  • Manage all ongoing early access programs
  • Establish performance metrics for each partner/consultant
  • Partner with local resources, if available
  • Oversee contract execution and management for all partners
  • Adapt global patient adherence programs to local markets
  • International Operations Strategy & General Responsibilities

EXPERIENCE AND QUALIFICATIONS:

  • The successful candidate will have 10+ years’ experience in biotech or pharmaceuticals, including work with highly specialized, small market pharmaceutical products
  • 5+ experience or at least two product launches in international markets
  • Experience with commercial and NPP pathways to product access
  • Minimum of bachelor’s degree in a science or technology, advanced degree preferred
  • Experience with local regulatory and pricing/reimbursement authorities
  • Able to drive performance in a multi-disciplinary environment
  • Comfortable working concurrently in multiple countries and regions
  • Domestic and global travel required 50-75%
  • Relocation assistance not provided.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

29) Associate CMC Director, Regulatory Affairs – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A113HN

DESCRIPTION:

  • Will report to the Director, Regulatory Affairs, CMC
  • Proactively managing CMC aspects of one or more global commercial programs including overseeing preparation and submission of global CMC submissions, including marketing and clinical trial applications. 
  • Ensuring that CMC content is complete, well-written, and meets all relevant requirements. 
  • Evaluating proposed manufacturing changes for global impact to ongoing and existing filings, and provides strategic regulatory guidance for optimal implementation of changes. 
  • Researching and interpreting global CMC regulations and, providing regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups.
  • Representing the Regulatory Affairs CMC function on assigned cross-functional project teams.
  • Managing interactions with FDA and other global regulatory authorities for assigned project to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information. 
  • Developing excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.

EXPERIENCE AND QUALIFICATIONS:

  • Thorough understanding of relevant drug development regulations and guidelines is essential.
  • Prior success filing marketing applications, supplements, and variations for biologic products within timelines is required; global submission experience desired.
  • Experience in assessing post-approval changes is required.
  • Demonstrated ability to coach, train and mentor teams.
  • Outstanding interpersonal and communication (written and verbal) skills is required
  • Strong writing and editing skills for technical documentation.
  • Proficient with computer and standard software programs.
  • Able to travel 10%.
  • At least 2 years of previous supervisory experience managing associates is required.
  • 6-8 years of experience in Regulatory Affairs in a global pharmaceutical and/or biotechnology company with expertise in biologics and deep experience in commercial product lifecycle as well as Phase 1-3.  
  • Experience with commercial small molecules may also be considered.
  • BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable.  Advanced degree is a plus.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

30) Scientist II, III - Protein Chemistry – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GR139H

DESCRIPTION:

  • The successful candidate will have a track record of success in the discovery, design, and optimization of antibodies and ECD-fc fusions with therapeutic potential.  
  • Experience developing and optimizing bi-specific antibodies is a plus. 
  • Strong leadership skills are required and the ability to work closely with a cross functional team of discovery biologists is required. 
  • The selected candidate will be a hands-on manager of direct reports and is expected to work at the bench as needed.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with multiple classes of therapeutic proteins, including antibodies, bi-specifics, receptor-Fc fusions, and secreted proteins is desirable
  • Experience with antibody selection, humanization and optimization is desired
  • Experience in protein modeling, structure-function mutational analysis, and protein engineering is a plus
  • Experience with high throughput instrumentation and automation technologies is preferred.
  • Excellent written and verbal communication skills, organizational skills, collaboration skills, and computer skills are required
  • The ideal candidate will have a proven track record of scientific and technological innovation, a significant reputation as an outstanding scientist in his/her field, and an eagerness to work as part of a team discovering new therapeutics 
  • Passion for protein discovery, design and optimization to generate first-in-class therapeutics
  • Broad understanding of protein science, including expression, purification, and characterization
  • Familiarity with high throughput technologies for production and functional testing
  • Excellent leadership skills
  • Collaborative spirit with creative intuition for generating next generation technologies 
  • Ph.D in a biochemistry or related discipline required with 5-8 years laboratory research experience
  •  

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

31) CRA III / Sr CRA – Clinical Operations – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) MB139W

DESCRIPTION:

Individual will play a key role in assisting the Clinical Development team in conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. Looking for candidates that are able to recognize and synthesize information about the organizational climate and partner with key individuals to accomplish organizational goals. Overall responsibilities may include the management of clinical operations activities and coordinating cross functional efforts in the administration and progress of a clinical trial(s) in order to achieve trial objectives and corporate goals.

Primary Responsibilities
  • The candidate, working closely with the cross functional team, under direction of the Associate Director, Clinical Operations, will have overall responsibilities for managing the full scope of clinical trials and coordinating efforts in order to achieve study objectives and corporate goals, including:
  • Implementation of clinical trial activities. May act as a global clinical trial lead to solicit RFPs and assist in identification of optimal CRO and manage CROs, clinical site personnel, and other study vendors. 
  • Assisting with managing defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines. 
  • Track key study metrics using tracking tools (creating and maintaining documents, tables, databases, spreadsheets and files), providing timely and quality updates to the study team.
  • Travel for site monitoring and/or co-monitoring activities, attend investigator meetings or vendor visits/audits, as required (up to 50%).
  • Create and/or review monitoring reports and monitoring visit letters. 
  • Assist clinical study sites with IRB/EC submissions and ensure collection and review of required essential study documents and reports. 
  • Work proactively with data management team in the design and development of eCRFs. 
  • Review completed eCRFs for accuracy.  Oversee data discrepancy management and retraining as needed. 
  • Develop strong working relationships and maintain effective communication within the development department as well as other functional departments within the company.
  • Provide or assist with training internal and external CRAs, CRO team members, and investigative site staff. 
  • Ensure that supportive study supplies and documents are available (e.g., contracts, IXRS, lab kits, non-clinical supply materials). 
  • Perform on-going review of the TMF to ensure files are properly maintained and up to date, archived and stored. 
  • Attend meetings, take and distribute meeting minutes.  

EXPERIENCE AND QUALIFICATIONS:

  • Global trial and CRO management experience is preferred.  
  • Proficiency with word processing, spreadsheet, database, and presentation software (MSOffice skills such as Outlook, Word, Excel, PowerPoint) and with filing systems.  
  • Oncology experience preferred but not required. 
  • BS/BA in Life Science or related discipline 
  • 5+ years industry experience in drug development, including prior on-site monitoring experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

32) Clinical Trial Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A129DK

DESCRIPTION:

Responsible for the operational management and oversight of clinical trials within a clinical development program; the level of independence and scope of responsibilities assigned may vary depending on the experience of the successful candidate.  The CTM will work closely with the Medical Monitor and other cross-functional representatives, including Clinical Data Management, Biostatistics, Regulatory/QA, Pharmacology, Biology to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget. Will also provide oversight of the CRO and other third party vendors on assigned study. This individual will report into the Director of Clinical Operations. This is an in-house position.  
 
  • Oversee performance of CROs, third party vendors, and field CRAs  including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Director or CRO as appropriate 
  • Perform clinical data review of data listings and summary tables, including query generation   
  • Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits 
  • Develop and maintain good working relationships with investigators and study staff 
  • Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study specific manuals and procedures 
  • Track and report on progress of study including site activation, patient enrollment, monitoring visits 
  • Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience)  
  • Investigate queries, monitor discrepancies 
  • Manage investigational product (IP) accountability and reconciliation process 
  • Responsible for review or approval of IP release packages 
  • Negotiate and manage the budget and payments for investigative sites, if applicable 
  • Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents 
  • Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work 
  • Assist with CRA and third party vendor training on protocols and practices  
  • Assist in identification and hiring of appropriate CROs and third party study vendors  

EXPERIENCE AND QUALIFICATIONS:

  • Experience in managing industry sponsored clinical (pharmaceutical) trials.  
  • Cross-functional team leadership experience preferred (at least 2 years)  
  • Management of international clinical studies preferred 
  • Cardiovascular and/or oncology study experience preferred  
  • Experience managing vendors, including performance assessments and total financial management (invoice review, change order management, budget reforecasting, etc.) 
  • Previous experience working with an electronic data capture system and CTMS system required  
  • Proficient with MS Word, Excel and PowerPoint.  Experience with MS Access and MS Project a plus 
  • Strong interpersonal, communication (written and verbal), and organizational skills  
  • Demonstrated ability to work independently as well as part of a multi-functional study team  
  • Able to motivate a team to work effectively under a changing environment  
  • Able to solve problems under pressure  
  • Self-motivated and able to work effectively in a matrix/team environment  
  • Availability for potential travel domestically and internationally 
  • Clinical operations work experience in the pharmaceutical industry and working knowledge of GCP/ICH guidelines and the clinical development process. 
  • Global Phase III experience in cardiovascular or oncology drug development desirable. 
  • Bachelor’s degree or equivalent 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

33) Marketing Development Manager – Contract (San Francisco Bay Area) 73Y1848

DESCRIPTION:

  • Responsible for the go-to-market strategy and demand generation for products within the NGS business unit. 
  • Will help drive the development and execution of marketing programs to support a growing business unit in a dynamic market environment. 
  • The successful candidate will coordinate closely with Product Management and Regional Marketing, as well as liaison with Corporate Marketing's Studio/Design and eMarketing teams, to deliver key assets designed to help achieve global sales, marketing, and revenue goals. 
  • Will laise with internal and outside vendors, maintaining excellent professional relationships, in order to facilitate the conversion of marketing ideas and messages into effective marketing communications deliverables.
  • Help develop strategic action plans that drive growth in key segments.
  • Develop messaging & tools that communicate the value/brand to specific segments/regions.
  • Develop content for web, print, PR, etc from product specifications and technical documentation.
  • Develop innovative and impactful collateral materials.
  • Create and deliver sales tools & sales training.
  • Manage project budgets and aggressive timelines.

EXPERIENCE AND QUALIFICATIONS:

  • Exceptional communication skills as well as analytical, project management and planning skills necessary.
  • Strong business acumen, marketing experience, and customer focus are essential.
  • Knowledge of the following key competencies: 4Ps and marketing mix, marketing communication, communication channels, channels-to-market, segmentation, value proposition and marketing program development and execution.
  • Effectiveness in this role requires the ability to clearly communicate verbally and in writing product area marketing plans, and a general knowledge of operating plans as well as industry practices for promoting and selling similar products.
  • Has thorough functional understanding of the market development role and in depth knowledge of next-generation sequencing markets a plus.
  • Ability to work on problems of routine to diverse scope.
  • Identifies problems, answers questions, gains cooperation of others and implements efficient solutions.
  • Bachelor’s degree in molecular biology or related discipline with at least 3 years experience in a marketing role
  • MBA strongly preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

34) Accounts Receivables Clerk – Contract (New York) 73P1775

DESCRIPTION:

  • Cash application of daily lockbox, wire and ACH payments
  • Process intercompany settlement log
  • Generate Intercompany invoices
  • Post cash to intercompany invoices
  • Generate refund requests, stipend and rebate requests, and commissions
  • Process Tax credits and credit memos.
  • Reduce unapplied cash balance
  • Process internal adjustments
  • Process credit card payments to invoices

EXPERIENCE AND QUALIFICATIONS:

  • Basic accounting.  
  • Communication both verbal and written.  
  • Computer literacy.  
  • Ability to prioritize and strong organizational skills.  
  • Must be able to multi-task. 
  • Must have an understanding of debits/credits.   
  • Accounts Receivable background is helpful.  
  • Minimal High School diploma

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

35) SCRA / CTM (Clinical Operations) – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) DH125N

DESCRIPTION:

  • Manage the execution of multiple clinical programs
  • Manage sites and vendors to assure successful execution of multiple clinical studies (Phase I through IV) from an operational standpoint: timeline, scientific quality and budget perspective with adherence to intra-company and ICH/FDA regulations and guidelines.
  • Act as point person for sites and external vendors; proactively supervise internal CRA(s), other functional teams, and external vendors, including central labs, and IRB
  • Assist CRA on site identification, selection, and qualification
  • Prepare for clinical trial materials, TMF, site regulatory bind,
  • Manage central IRB submission and approval and drug shipment
  • Prepare for SIV
  • Manage advertising program
  • Track trial activities including study timelines, budgets, and quality of the trial/program conduct
  • Maintain the day-to-day communication among sites and vendors
  • Prepare for all reports/documents, e.g., monthly reports, meeting minutes, enrollment reports, monitoring reports, investigator payments and invoices
  • Act as the primary person for resolving emerging issues and problems during the study
  • Oversee SAE report and coordinator activities with Medical Monitor
  • Communicate the study status and issues to the internal project team and sponsor
  • Implement Phase I-IV trials and perform co-monitoring as appropriate.
  • Ensure the integrity and validity of all data by thoroughly reviewing all documentation and by identifying areas of concern throughout the study process.

EXPERIENCE AND QUALIFICATIONS:

  • Preferred experience as both in-field and in-house monitoring, with either previous experience working for or supervising CRO activities, with preferably two years or more trial management experience .
  • Excellent written and verbal communication skills.
  • Ability to use a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions.
  • Life science degree (BS, RN, or higher).
  • Minimum 7 years pharmaceutical clinical trials experience (may include combination of investigative site, CRO, pharmaceutical CRA experiences).

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

36) Data Entry Operator – Contract (San Francisco Bay Area) 73M2018

DESCRIPTION:

  • Responsible for organizing and preparing data related to chemical compliance and international product registrations.   
  • The candidate will provide necessary data and analytics to support product compliance.  
  • This role will include manipulation of large data sets comprise of chemical product composition and other attributes, preparation of reports from MS Excel, Access and other database and ERP systems.   
  • Will regularly communicate/interact with global chemical compliance teams.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent organizational skills and attention to detail are required to complete tasks with high accuracy. 
  • The incumbent exercises judgment within defined procedures and practices while receiving adequate guidance to the task.
  • Demonstrated competency in use and manipulation of Excel spreadsheets and Access databases
  • 2-3 years working experience with database or similar software platforms
  • Ability to understand and apply complex data standards as they relate to chemical products
  • Comfortable in working in office environment with direct supervisory support and participate in tele and web conferences
  • Motivated/results-orientated
  • Detail minded
  • Comfortable working across multiple IT platforms and software systems
  • Anticipates needs and problems while creating solutions
  • Associates degree or Bachelors Degree (preferred)

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

37) Senior Project Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) G132XT

DESCRIPTION:

  • Will manage projects in clinical development. 
  • Will be accountable for guiding drug development teams through corporate processes.
  • Partner with Team Leader to manage the development and execution of project team strategy and to optimize team effectiveness in achieving project objectives in alignment with budget and timeline.
  • Establish and maintain functionally integrated project schedules to enable accurate project, financial and portfolio analyses and ensure accurate inputs are provided into business planning processes; Ensures alignment with project sub-teams and functional partners.
  • Oversees and prepares project team budget including resources and costs collaborating with Finance and other cross-functional departments
  • Ensure project team activities and decisions are clearly communicated, documented and archived, act as a primary contact for project team related information.
  • Facilitate project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders.
  • Identifies, recommends, and manages the implementation of process and other improvements; whether pertinent to departmental and/or corporate.
  • Supports CMC and publication sub-teams as needed.

EXPERIENCE AND QUALIFICATIONS:

  • Advanced degree in science is desired (e.g. MS, PhD, MBA) or commensurate experience
  • 8 or more years multi-disciplinary experience in the biotech/pharmaceutical industry with 4 - 8 years direct project management in drug development
  • Strong proficiency with project management practices, tools, and methodology.
  • Outstanding knowledge of overall drug development process relevant to pharmaceutical/biotech organizations.
  • Financial acumen; capable of planning and oversight of project budgets and product valuations and an understanding of portfolio management concepts.
  • Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills.
  • Excellent analytical skills, with an ability to communicate complex issues in a simple way.
  • Demonstrate ability to translate strategy into action; Strong influence, negotiation, and presentation skills.
  • Proven track record of good decision making and exercising sound judgment.
  • Results and detail-oriented; self-motivated.
  • Proven experience using Project Management software to manage complex project timelines and resources.
  • Working knowledge/understanding of best-practice alliance/collaboration management principles and concepts, techniques and tools.
  • Successful experience in managing direct reports a plus.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

38) Marketing Development Manager – Contract (San Francisco Bay Area) 1149K73

DESCRIPTION:

  • Responsible for the go-to-market strategy and demand generation for digital PCR and real-time PCR solutions.  
  • Will lead the development and execution of strategic marketing plans to support a growing business unit in a dynamic market environment. 
  • Coordinate with Product Management and Regional Marketing to develop plans and positioning as well as liaison with Corporate Marketing’s Studio/Design and e-Business teams to execute integrated marketing communications programs designed to help achieve global sales, marketing, and revenue goals. 
  • As project lead and liaison to internal and outside vendors, maintaining excellent professional relationships, in order to facilitate the conversion of marketing ideas and messages into effective marketing communications deliverables.
  • Lead cross functional teams to develop strategic action plans that drive growth in key segments.
  • Develop messaging & tools that communicate the value/brand to specific segments/regions.
  • Develop content for web, print, PR from product specifications and technical documentation.
  • Develop innovative and impactful collateral materials.
  • Create and deliver sales tools & sales training.
  • Manage project budgets including tracking actual versus plan.

EXPERIENCE AND QUALIFICATIONS:

  • Must have thorough functional understanding of the market development role and in depth knowledge of major genetic analysis markets.
  • Must have the ability to effectively communicate in both oral and written formats
  • Proficiency in Microsoft Office (Word, Excel, and PowerPoint) is a must
  • Previous experience in selling or marketing real-time PCR Systems or digital PCR system desired
  • Previous experience in working in fast-pace or large matrix environment desired
  • Must have Bachelor’s degree in molecular biology or related discipline with 5 years experience in a marketing role
  • Desired MBA, or PhD in molecular biology

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

39) Packaging Technician – Contract (Pennsylvania) 9389

DESCRIPTION:

  • Responsible for activities supporting the primary and secondary packaging, labeling, and assembly, warehousing, and shipping preparation of investigational drugs used in various clinical studies.
  • Sign and date batch records for activities performed on all supplies prepared for clinical investigation and verify the work of other production staff members.
  • Work is assigned and reviewed by Packaging Supervisor, Production Supervisors, Warehouse Supervisor, and/or Team Leaders.
  • Instructions will be in the form of written batch records as well as verbal instructions.

EXPERIENCE AND QUALIFICATIONS:

  • Must be detailed oriented and dependable.
  • Able to work independently and in a team environment.
  • Must have the ability to read, especially small and repetitive text patterns and the ability to follow numeric sequences and perform accurate counting.
  • Must be capable of performing repetitive motions and lifting small to medium sized loads of 30 to 50 pounds.
  • High school diploma or equivalent is required.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

40) Principle Investigator / Technical Writer – Contract (Pennsylvania) 8199

DESCRIPTION:

  • Authoring and resolution of deviations, change controls, CAPAs,or documents in order to meet production and product release requirements.
  • Identification and facilitation of interdepartmental process improvements. 
  • Utilize root cause analysis techniques during deviation investigational process
  • Work cross functionally, to develop and  implement continuous process improvements
  • Support production needs and continuous improvement including change control, deviation writing / review, CAPA implementation, and operational optimization. 
  • Collaboration with Technical Writers to  write, review, revise and prepare manufacturing documents (BPR, SOP, SWI, , etc) in accordance with cGMP and regulatory guidelines. 
  • Communicate across multiple groups and levels to obtain consensus in order to facilitate deviation closure
  • Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization
  • Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor Level degree or 3-5 years equivalent experience  
  • Previous experience working within a production department of a pharmaceutical company preferred.  
  • Working knowledge of cGMP's.
  • Must have knowledge of continuous improvement techniques and problem solving skills. 


To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

41) Engineering Technician – Contract (San Francisco Bay Area) 73G4864

DESCRIPTION:

  • Performs maintenance, testing, troubleshooting, calibration and repair on a variety of manufacturing and testing Instrumentation.
  • Carries out routine repairs on a daily basis.
  • Provides technical support to internal customers on operational or maintenance aspects of system equipment.
  • Works independently and prioritizes work schedule of service calls a majority of the time, may require direction from Lead or Supervisor sporadically.
  • Maintains own tool inventory to ensure adequate supply to perform duties.
  • Works with team and administrator to assure there is adequate supply of spare parts in stockroom (specifies and requests purchase of components).
  • Performs all administrative duties including documenting maintenance and repair calls in SAP as well as completing required documentation and reports.
  • Proficient and compliant with ISO standards and practices.

EXPERIENCE AND QUALIFICATIONS:

  • Experience highly desirable : Robotic instrumentation (especially HPLC, Hamilton, Bravo, and Biomek FX), liquid handling instruments, and pneumatic instruments
  • Knowledge of GMP, ISO 9001, and 13485 processes
  • Experience with general handheld tools plus multimeters and other electronic test equipment.
  • Working knowledge of molecular biology, chemistry, and/or biology preferred.
  • Must be able to work effectively alone under minimal supervision and complete assigned work targets in a timely manner. 
  • Excellent organizational skills, including the ability to handle multiple  work tasks and priorities.
  • Excellent verbal and written communication skills and the ability to interpret and summarize scientific/technical results in a clear, concise, accurate manner.
  • Demonstrated ability to formulate and solve problems.
  • Must be flexible to work weekends and overtime during the week or swing shift. 
  • Minimum High School Diploma
  • Experience: 1-2 years repair experience (Field Service or In-House Service)

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

42) Health, Safety, and Environment (HSE) Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) B131DM

DESCRIPTION:

  • Responsible for the administration of Health, Safety, and Environment (HSE) programs for design, construction and operational support of site pharmaceutical manufacturing facility. 
  • Plans, implements and coordinates HSE programs to reduce or eliminate occupational injuries and illnesses, and to prevent environmental impacts. 
  • Delivers training, identifies, evaluates and eliminates occupational hazards and ensures site compliance with governmental regulations and HSE Policies and Guidelines. 
  • Manages HSE details of large capital projects, and provides HSE support to ongoing site operations. 
  • Independently resolves a wide variety of issues of complex scope. 
  • Analyzes and evaluates process and operational hazards and mitigates risks. 
  • Contributes to the design of mechanical systems, and wastewater and air pollution abatement systems, and verifies system operation. 
  • Addresses questions and/or issues related to HSE regulatory and corporate requirements in support of project design and construction, process hazard analysis, containment and risk mitigation. 
  • Provides point of contact for regulatory agency visits and compliance investigations. 
  • Plans, develops and manages site procedures for adhering to local, state and federal HSE regulations.

EXPERIENCE AND QUALIFICATIONS:


  • Minimum of 7 years' experience in HSE administration. CIH or CSP certification desirable. 
  • Knowledge of OSHA, EPA and NFPA regulations and codes. 
  • Preferred safety training includes: 24-hour HAZWOPER, OSHA 10-hour General Industry, OSHA 10-hour Construction Industry, and Asbestos Hazard Emergency Response Act (AHERA), and Title 22 California Hazardous Waste Management, and First aid, CPR/AED. 
  • Familiarity with Facilities Engineering and construction Project Management is highly desirable. Examples: HVAC, RODI, Electrical systems, BMS/BAS. 
  • Ability to work with all levels of management. Lead and direct the work of others. 
  • Extensive experience and judgment to plan and accomplish goals. 
  • Strong written and oral communications skills. 
  • Ability to work in high stress environment, to perform multiple tasks, to make decisions and handle emergency situations
  • Professional Engineer or Master of Science degree in HSE-related field of study; or Bachelor Degree with equivalent work experience in pharmaceutical industry

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

43) Senior Biostatistician / Manager, Biostatistics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) B111DK

DESCRIPTION:

  • Work with clinical development teams in the design and conduct of clinical studies and in the evaluation, interpretation and preparation of study results.
  • Provide sound experimental design and data analysis expertise.
  • Author the protocol statistical sections and generate statistical analysis plans and study randomization as needed.
  • Review and sign off on relevant study documents and data management deliverables.
  • Prepare and review mockup tables, figures and listings. Determine analysis and data presentation specifications for CRO programmers and statisticians.
  • Provide verification and QA reviews on final tables, figures and listings.
  • Perform analysis, interpret study results, and collaborate with medical and biostatistics staff to produce interim reports, final reports, and publications.
  • Represent the biostatistics and programming functions on project teams.
  • Work with biostatistics and clinical staff to define datasets and analyses for the integrated summary of safety and efficacy. Interpret results of integrated summary analyses and collaborate with medical and biostatistics staff to produce reports for the application to regulatory agencies.

EXPERIENCE AND QUALIFICATIONS:

  • Must possess a comprehensive and detailed understanding of statistical experimental designs and analyses, clinical trial requirements and statistical software packages such as SAS.
  • Understanding of regulatory guidelines that affect statistical deliverables.
  • Experience with the management and statistical analysis of data obtained from Phase I-III clinical trials or studies in support of U.S. PLAs/NDAs.
  • Experience with PLA/NDA submission a plus.
  • Strong interpersonal and effective communication (oral and written) skills
  • Minimum: Ph.D. in Biostatistics, Statistics or closely related discipline with >2 years’ experience, or a Master's Degree in Biostatistics, Statistics or closely related discipline with >4 years’ experience in the support of clinical studies in a pharmaceutical industry or clinical studies setting.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

44) Statistician – Contract (New Jersey) 6150

DESCRIPTION:

  • Work on the planning and implementation of statistical analyses for ISE and ISS in preparation of a NDA submission, based on existing clinical studies. This entails identifying and understanding existing clinical studies including databases, developing SAPs for ISE and ISS, directing programmers in the integration of clinical databases and generation of statistical analysis outputs, reviewing ISE and ISS documents. 
  • Occasional SAS programming to generate ad hoc analyses is expected.
  • Will serve as study statistician under the guidance of the statistical project lead, providing statistical support to all study related activities, including participating in Clinical Trial Team meetings, SAP development, IVRS specifications, CRF review, working with assigned programmer(s) to set up study database, take leadership role in data review related activities. 
  • Provide support to the planned activities, e.g., generation of open report, as appropriate, transmit blinded data to a 3rd party, 
  • May also coordinate certain randomization related activities with an IVRS vendor.

EXPERIENCE AND QUALIFICATIONS:

  • At least 5 years experiences with Pharmaceutical or Biotech companies.
  • Ph.D or Master in Statistics/Biostatistics or very closely related areas. 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

45) Web Content Specialist – Contract (Southern California) 2894Q73

DESCRIPTION:

  • Enter, review, and manage life science product and technical information in a database that serves as the primary source for an online product catalog and eCommerce system. 
  • Work closely with groups such as product management, marketing management, and web content managers to obtain the necessary product information, ensure its accuracy/quality, optimize it for the web, and launch it on the web site at the appropriate time. 
  • Use hands-on experience with life science research techniques and familiarity with the scientific literature to guide product allocation and attribute selection. 
  • Develop and maintain a working knowledge of the company's life science products, how they are used and how they relate to other products. 
  • Helps to edit and reviews web pages that describe or feature a wide range of life sciences products across the web site, aligning them to editorial, digital, and brand style guidelines.

EXPERIENCE AND QUALIFICATIONS:

  • Strong knowledge of molecular, cellular, and/or protein biology research techniques including PCR, cloning, protein expression, qPCR, and antibody production and labeling. 
  • Excellent organizational skills, including the ability to efficiently evaluate, sort, and categorize disparate types of data with a keen attention to detail. 
  • Must also have excellent writing skills, particularly the ability to interpret complex scientific information and present it in a clear, concise, e manner. 
  • Basic knowledge of HTML is a plus, as is familiarity with traditional and online marketing concepts. 
  • Excellent computer skills and the ability to problem-solve, multi-task, and prioritize while working independently to meet deadlines in a fast-paced environment is critical for success in this position.
  • A Masters or Doctoral degree in a Life Science Research Area (Protein Biology, Cell Biology, Molecular Biology, Biochemistry, or a related field) OR a Bachelors degree in a Life Science plus at least 3 years hands-on laboratory experience in Life Science. 
  • Familiarity with Excel, HTML, and/or content management systems.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

46) Sr Project Manager Process Improvements & Analytics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GP113F

DESCRIPTION:

  • Will partner with clinical development functions and project teams to develop scalable, robust, and streamlined business processes that meet business needs and support achievement of goals and objectives.  
  • Supports development sciences functions by acting as a liaison between project teams, management, and technology management groups for process improvement initiatives and analytics.
  • Leads the development of optimized business processes, process improvements, and change initiatives that meet business needs and support achievement of development sciences goals and objectives
  • Partners projects teams and functions to identify process gaps and involved in defining actionable response strategies 
  • Partners with clinical project teams and business technology management to deliver business results focused on establishing and improving business processes that improve reliability, increase simplicity, and enable growth 
  • Oversees metrics reporting dashboard and associated metrics tools
  • Analyzes and interprets metrics data to provide business insights and answer key business questions that help the development sciences organization make data driven process improvement decisions
  • Coaches, motivates, and provides career and technical advice to business analysts 

EXPERIENCE AND QUALIFICATIONS:

  • Experience successfully applying business analytics and metrics to process improvement projects
  • Demonstrated project management skills with proven ability to oversee and/or manage multiple tasks to conclusion, on time, and without compromise to quality of work output
  • Cross-functional understanding of drug development processes 
  • Awareness of clinical systems including but not limited to CTMS, EDC, and IXRS
  • Experience working in a regulated environment 
  • Highly proficient with project management tools and processes (e. g. MS Project, Excel, PowerPoint, and Visio)
  • Experience with formal process improvement methodologies including Business Analysis, Balanced Scorecard, LEAN, and/or BPMN 
  • 7+ years related experience leading -functional teams in successful business process analysis, design, and optimization
  • BS/BA required with 12-15 years of related experience in pharma/biotech business/operations, 10-13 years with a Masters, 7 - 10 years with a PhD or 2+ Master’s
  • PMP or BPM Certification and/or certification in an established process improvement methodology preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

47) Laboratory Technical Supervisor – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) Z138AG

DESCRIPTION:

  • Develop a nationally recognized CLIA reference laboratory.
  • Ensure compliance with state and federal regulatory agencies, including timely submission of proficiency testing.
  • Conduct inspection preparation and lead onsite inspections.
  • Act as a Quality Systems Manager and evaluate the policies, procedures, and processes as well as implement laboratory improvements.
  • Oversee laboratory Quality Assurance/Quality Compliance and conduct annual review.
  • Participate in review/approval of all relevant documents and procedures.
  • Ensure smooth operations of high complexity laboratory, including inventory control, results accessioning and reporting, and documentation of variances.
  • Achieve greatest level of test accuracy, timeliness and medical value for a growing patient base.
  • Documentation and implementation of remedial action whenever laboratory testing deviates from best practices.
  • Work with R&D to validate novel testing systems.
  • Develop new tests and maintain existing procedures, following NCCLS guidelines for SOPs.
  • Maintain patient and laboratory records consistent with state and federal regulations.
  • Oversee customer satisfaction and implement procedures for resolving complaints.
  • Evaluate, document, and ensure competency of all testing personnel consistent with state and federal guidelines, and high levels of team productivity and collegiality.
  • Develop laboratory budget to ensure efficient use of resources.
  • Understand and implement OSHA and CLIA requirements.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent analytical and laboratory skills.
  • Experience with a broad array of assays including clinical chemistry, hematology, microbiology, and molecular diagnostics.
  • Experience managing clinical laboratory personnel.
  • Experience managing new laboratories, or sections of laboratories, consistent with best practices and lean/six-sigma principles is highly desirable.
  • Experience with preparing for and coordinating laboratory inspections by State and Federal agencies.
  • Desire to be part of a fast-paced, rapidly growing start-up company.
  • Proficiency with procedures to ensure analytic performance such as Westgard rules and Levey-Jennings analysis.
  • Proven ability to help scale clinical laboratories in a dynamic environment while maintaining excellence in performance at every level.
  • Graduation from an accredited CLS program.
  • Hold a current Clinical Laboratory Scientist license issued by the State of California.
  • At least 4 years of experience in high complexity testing with a proven track record of exceeding quality expectations.
  • Bachelor's degree in chemical, physical or biological science or medical technology from an accredited institution

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

48) Laboratory General Supervisor – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BX138R

DESCRIPTION:

  • Develop a nationally recognized CLIA reference laboratory.
  • Ensure compliance with State and Federal regulatory agencies, including timely submission of proficiency testing.
  • Monitor patient testing and specimen acceptability to ensure accurate analytic performance.
  • Provide orientation and training to all testing personnel.
  • Management of accessioning, test performance and critical analysis of patient results reporting in collaboration with the laboratory director.
  • Coordinate send-out testing to reference laboratories.
  • Achieve greatest level of test accuracy, timeliness and medical value for a growing patient base.
  • Work with R&D to validate clinical diagnostic instrumentation.
  • Manage successful introduction of new tests to laboratory, and maintain existing procedures, following NCCLS guidelines for SOPs.
  • Oversee customer satisfaction and implement procedures for resolving complaints.
  • Ensure competency of all testing personnel and high levels of team productivity and collegiality.
  • Work with Technical Supervisor and Lab Director to develop laboratory budget to ensure efficient use of resources.
  • Understand and implement OSHA and CLIA requirements.

EXPERIENCE AND QUALIFICATIONS:

  • Experience working with a broad array of assays including clinical chemistry,
  • Desire to be part of a fast-paced, rapidly growing start-up company.
  • Hematology, Microbiology, and Molecular Diagnostics.
  • Experience managing clinical laboratory personnel.
  • Experience managing new laboratories, or sections of laboratories, consistent with best practices and lean/six-sigma principles is highly desirable.
  • Strong knowledge and experience with public health laboratory laws and regulations.
  • Proven ability to help scale clinical laboratories in a dynamic environment while maintaining excellence in performance at every level.
  • Graduation from accredited CLS program
  • Hold a current Clinical Laboratory Scientist license issued by the State of California
  • At least two years of experience in high complexity testing, with proven track record of exceeding quality expectations.
  • Bachelor's degree in chemical, physical or biological science or medical technology from an accredited institution.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

49) Clinical Microbiology Supervisor – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) JP138C

DESCRIPTION:

  • Develop a nationally recognized CLIA reference laboratory.
  • Ensure compliance with state and federal regulatory agencies, including timely submission of proficiency testing.
  • Conduct inspection preparation and lead onsite inspections.
  • Act as a Quality Systems Manager and evaluate the policies, procedures, and processes as well as implement laboratory improvements.
  • Oversee laboratory Quality Assurance/Quality Compliance and conduct annual review.
  • Participate in review/approval of all relevant documents and procedures.
  • Ensure smooth operations of high complexity laboratory, including inventory control, results accessioning and reporting, and documentation of variances.
  • Achieve greatest level of test accuracy, timeliness and medical value for a growing patient base.
  • Documentation and implementation of remedial action whenever laboratory testing deviates from best practices.
  • Work with R&D to validate novel testing systems.
  • Develop new tests and maintain existing procedures, following NCCLS guidelines for SOPs.
  • Maintain patient and laboratory records consistent with state and federal regulations.
  • Oversee customer satisfaction and implement procedures for resolving complaints.
  • Evaluate, document, and ensure competency of all testing personnel consistent with state and federal guidelines, and high levels of team productivity and collegiality.
  • Develop laboratory budget to ensure efficient use of resources.
  • Understand and implement OSHA and CLIA requirements.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent analytical and laboratory skills.
  • Experience with microbiology; Manage the processing of infectious specimens, conduct testing, and report test results with constant attention to detail and excellence in quality.
  • Experience managing clinical laboratory personnel.
  • Experience managing new laboratories, or sections of laboratories, consistent with best practices and lean/six-sigma principles is highly desirable.
  • Experience with preparing for and coordinating laboratory inspections by State and Federal agencies.
  • Proficiency with procedures to ensure analytic performance such as Westgard rules and Levey-Jennings analysis.
  • Proven ability to help scale clinical laboratories in a dynamic environment while maintaining excellence in performance at every level.
  • Desire to be part of a fast-paced, rapidly growing start-up company.
  • Under the direction of technical and general supervisors, perform microbiological and/or DNA and RNA oriented laboratory procedures in accordance with standards established in the Clinical Laboratory Improvement Amendments (CLIA).
  • Resolve problems that may adversely affect test performance or reporting of test results
  • Assist with quality assurance and performance improvement activities.
  • Either a current California State Clinical Laboratory Scientist License (a Generalist or a limited license in Microbiology or Clinical Genetics Molecular Biology) or Public Health Microbiology (California) certification.
  • At least 4 years of experience in high complexity testing with a proven track record of exceeding quality expectations.
  • Bachelor's degree in Clinical Lab Sciences or related field.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

50) Senior Clinical Trial Manager – Contract (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BT108K

DESCRIPTION:

  • Responsible for the execution and strategic oversight of one or more related clinical trials
  • Manages all aspects of one or more clinical trials to ensure clinical operation activities are completed in compliance with SOPs, regulatory requirements, and ICH regulations.
  • Independently leads internal study teams to ensure study timelines, costs, and data quality standards are met. 
  • Evaluates and implements strategies to mitigate potential or real deficiencies in clinical timelines, costs, and quality.
  • Models the timing and budget implications of various clinical program strategies
  • Leads CRO and vendor selection process for assigned projects; perform effective ongoing performance and financial management of CROs and vendors. 
  • Assesses present and projected demands of a clinical program and partners with manager to appropriately identify and secure resources.
  • Leads internal and external development of key study documents including, but not limited to study protocol, study procedure manuals and project tools, monitoring plans and informed consents.
  • Evaluates, manages and facilitates the timely flow of clinical data to support program objectives
  • Oversee the forecasts to maintain sufficient clinical and non-clinical supplies
  • Partners with legal and financial functions to negotiate study contracts and budgets.
  • Maintains frequent contact with and works effectively with study stakeholders including investigators, vendors, and internal staff
  • Provides guidance, clinical trial management expertise, and direction to study team members.
  • Assists in preparation of clinical study reports, annual reports, Investigator’s Brochure updates
  • Contributes to clinical department development and infrastructure.

EXPERIENCE AND QUALIFICATIONS:

  • Advanced computer skills: MS Word, Excel, PowerPoint, Outlook, and Project
  • Cross-functional leadership to facilitate team meetings and drive study progress
  • Experience developing study execution strategies, risk mitigation, and successful site/country selection
  • Ability to work independently
  • Outstanding written and verbal communication skills. 
  • Extensive knowledge of clinical study methods and cross-functional needs
  • Ability to multi-task as needed in a start-up environment
  • International travel may be required
  • Eight or more years of relevant experience in clinical development, including at least 3 year experience as a clinical trial manager
  • Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
  • Prior experience with infectious disease a plus
  • Requires a Bachelors' Degree in a scientific discipline; Masters Degree a plus

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

51) Regulatory Affairs Associate / Specialist – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) XR111F

DESCRIPTION:

  • Provide support and technical assistance to regulatory personnel reporting directly to either an Associate Director or Director of Regulatory Affairs.
  • Assist efforts associated with the preparation of regulatory documents or submissions for domestic or international projects.
  • Obtain documents/information for regulatory submissions from various functional areas and check for errors, legibility, and missing information.
  • Prepare routine regulatory correspondence, draft more complex correspondence, and assure submission to government agencies in support of investigational and marketed products is completed in accordance with supervisor’s requirements and guidance.
  • Support technical review of data or reports that will be incorporated into regulatory submissions to assure scientific accuracy, clarity and regulatory compliance.
  • Review clinical documents to ensure that data collection and submission meets global and regional accepted regulatory standards.
  • Participate in project teams and interacts and coordinate with personnel in other departments including Marketing, Legal, Clinical, Medical Writing, and Project Management as well as Regulatory Affairs counterparts outside the company as needed.
  • Maintain and disseminate current knowledge base of existing regulations, standards, or guidance documents and proactively seek and find information to help resolve questions related to assigned projects.
  • Assists in archiving regulatory documentation and maintaining related databases.

EXPERIENCE AND QUALIFICATIONS:

  • Has a positive approach to work projects and maintains constructive and positive interactions with colleagues.
  • Willingness and ability to learn and adapt quickly in a changing and fast paced work environment.
  • Good verbal and written communication skills and excellent comprehensive reading skills.
  • Exceptional planning, organizational, and prioritizing skills as well as attention to detail.
  • Proficiency in the use of MS Word, PowerPoint, and Excel; experience with Adobe Acrobat Professional a plus.
  • Position requires a minimum of 2 years relevant work experience in Regulatory Affairs. 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

52) Scientist – Contract (Southern California) 73Z6685

DESCRIPTION:

  • The successful candidate will apply his/her in-depth knowledge in Molecular Biology to complete services projects or to develop new platform technologies. 
  • Will design, plan, and conduct laboratory experiments independently. 
  • Job duties will include leading Services projects. 
  • Training and guidance of other team members may be also required.
  • Solve problems associated with their project through application and integration of analytical skills, creativity, and judgment utilizing appropriate scientific principles.
  • Interact regularly with peers, subordinates, and functional peer groups, as well as customers and will present complex problems across functional areas. 
  • Write technical reports, develop protocols, and may give technical presentations to customers or at meetings.
  • All deliverables will impact business performance and operational efficiency.

EXPERIENCE AND QUALIFICATIONS:

  • Molecular Biology techniques (i.e. RNA, qPCR, DNA cloning) is required, expertise in cell biology is a plus. 
  • Setup of high throughput experiments and hands–on experience with automated instruments and database management (i.e. LIMS) are highly preferred. 
  • The successful candidate should also have excellent organization and communication skills.
  • B.S. with 5 years of relevant experience, M.S. with 3 years of relevant experience, or Ph.D. in Molecular Biology or related discipline.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

53) Clinical Project Leader – Full Time (San Francisco/South Bay/Marin/Sonoma/Napa/Santa Rosa/Petaluma) W109FJ

DESCRIPTION:

  • Responsible for all aspects of project management and coordination of cross-functional projects initiated by medical clinical affairs. This includes the review of project proposals, budgets, and contracts, as well as tracking of all milestones, budgets, and timelines. 
  • Responsible and accountable for assuring that the project team under her or his leadership meets all deadlines and is also required to maintain a close effective working relationship with sponsors, customers, vendors, leadership, and stakeholders. 
  • Demonstrate strong project management skills with the ability to manage project budgets, deliverables, and timelines successfully 
  • Lead cross-functional project teams through successful completion of the project in a matrix team environment 
  • Effectively manage budgets and resources, reduce costs, maintain and accelerate timelines, as well as track and execute the project schedule. 
  • Drives the quality and completion of phase reviews, all milestones and deliverables.
  • Must be able to understand and solve technical issues at a detailed level 
  • Provides leadership to resolve action items 
  • Coordinate the development of project timelines and manage any changes, such as  future timeline changes that may result from changes in scope, delays in schedule or resource constraints
  • Evaluate potential risks and develop preventive and corrective action plans
  • Develop and finalize complete project plans with formalized project budgets, resources, milestones, and deliverable schedule 
  • Coordinates all project update meetings and present or lead presentations for project status reviews 
  • Facilitate and maintain records of all internal and external communications relevant to assigned projects 
  • Manage contractors, consultants, vendors, and suppliers 
  • Develop and tracks all project budgets, milestones and customer deliverables
  • Assist MCA leadership with justifications, budget estimates, resource requirements, and presentations to support new project proposals 
  • Prepare all project related reports on project performance for both internal and external stakeholders
  • Monitor and present project quality performance at periodic project review meetings 
  • Lead multiple projects and facilitate project activities to ensure project specifications and timelines are met.

EXPERIENCE AND QUALIFICATIONS:

  • Develop and manages an interdisciplinary project team throughout the life cycle of the project, including the evaluation phase 
  • Develop and review all project plans, schedule, proposals, budgets and contracts. 
  • Ensure all milestones are met, if not, take appropriate corrective actions and notify stakeholders 
  • Must be knowledgeable in healthcare 
  • Must be able to prioritize multiple, competing tasks with excellent organizational and communication skills. 
  • Require the ability of independent decision making based upon current factors related to specifics of each project. 
  • Use leadership skills to ensure that cross-functional resources are assigned and held accountable for task and outcome completion. 
  • Have demonstrated track record of leading within complex organizations requiring strong influence and people management skills. 
  • Establish communication plans for projects and ensure adherence to the plans and maintain appropriate communication to all project members and stakeholders.
  • Manage risk assessment and mitigation process for assigned projects.
  • Ensure adherence to established project management methodologies and best practices.
  • Excellent presentation skills
  • 3-5 years of project management experience in healthcare industry with a proven track record managing complex projects.
  • Proven knowledge of project management methodologies
  • Proven organizational and planning skills
  • Bachelor’s Degree in Life Science, Healthcare or Nursing 
  • Preferred Masters or Project Management Training 
  • Preferred working experience with dialysis or renal disease.  Experience with project management tools and best practices

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

54) Lab Tech – Contract (Texas) 5219X73

DESCRIPTION:

  • Perform basic lab functions: aliquoting materials, material transfers, lab maintenance, material receipts, documentation, simple product formulations.

EXPERIENCE AND QUALIFICATIONS:

  • Preferably has laboratory experience. Will train fully.
  • Has some experience with some common laboratory procedures. 
  • Pipet reproducibly. Use of common equipment: balances, table top centrifuges, water baths, incubators etc. 
  • Has good verbal and written communication skills.  
  • Basic knowledge of word processing, spreadsheet programs, presentation software, and e-mail.  
  • Adherence to ISO guidelines. 
  • Actively participates in maintaining a safe, clean, and functional work environment. 
  • Follows directions and instructions accurately. 
  • Accurate and reliable inventory management participation. 
  • Reliable and punctual attendance.
  • HS/ GED required. 
  • Prefer associates or bachelor's degree in biotechnology or related field.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

55) Clinical Project Leader – Full Time (San Francisco/South Bay/Marin/Sonoma/Napa/Santa Rosa/Petaluma) W109FJ

DESCRIPTION:

  • Responsible for all aspects of project management and coordination of cross-functional projects initiated by medical clinical affairs. This includes the review of project proposals, budgets, and contracts, as well as tracking of all milestones, budgets, and timelines. 
  • Responsible and accountable for assuring that the project team under her or his leadership meets all deadlines and is also required to maintain a close effective working relationship with sponsors, customers, vendors, leadership, and stakeholders. 
  • Demonstrate strong project management skills with the ability to manage project budgets, deliverables, and timelines successfully 
  • Lead cross-functional project teams through successful completion of the project in a matrix team environment 
  • Effectively manage budgets and resources, reduce costs, maintain and accelerate timelines, as well as track and execute the project schedule. 
  • Drives the quality and completion of phase reviews, all milestones and deliverables.
  • Must be able to understand and solve technical issues at a detailed level 
  • Provides leadership to resolve action items 
  • Coordinate the development of project timelines and manage any changes, such as  future timeline changes that may result from changes in scope, delays in schedule or resource constraints
  • Evaluate potential risks and develop preventive and corrective action plans
  • Develop and finalize complete project plans with formalized project budgets, resources, milestones, and deliverable schedule 
  • Coordinates all project update meetings and present or lead presentations for project status reviews 
  • Facilitate and maintain records of all internal and external communications relevant to assigned projects 
  • Manage contractors, consultants, vendors, and suppliers 
  • Develop and tracks all project budgets, milestones and customer deliverables
  • Assist MCA leadership with justifications, budget estimates, resource requirements, and presentations to support new project proposals 
  • Prepare all project related reports on project performance for both internal and external stakeholders
  • Monitor and present project quality performance at periodic project review meetings 
  • Lead multiple projects and facilitate project activities to ensure project specifications and timelines are met.

EXPERIENCE AND QUALIFICATIONS:

  • Develop and manages an interdisciplinary project team throughout the life cycle of the project, including the evaluation phase 
  • Develop and review all project plans, schedule, proposals, budgets and contracts. 
  • Ensure all milestones are met, if not, take appropriate corrective actions and notify stakeholders 
  • Must be knowledgeable in healthcare 
  • Must be able to prioritize multiple, competing tasks with excellent organizational and communication skills. 
  • Require the ability of independent decision making based upon current factors related to specifics of each project. 
  • Use leadership skills to ensure that cross-functional resources are assigned and held accountable for task and outcome completion. 
  • Have demonstrated track record of leading within complex organizations requiring strong influence and people management skills. 
  • Establish communication plans for projects and ensure adherence to the plans and maintain appropriate communication to all project members and stakeholders.
  • Manage risk assessment and mitigation process for assigned projects.
  • Ensure adherence to established project management methodologies and best practices.
  • Excellent presentation skills
  • 3-5 years of project management experience in healthcare industry with a proven track record managing complex projects.
  • Proven knowledge of project management methodologies
  • Proven organizational and planning skills
  • Bachelor’s Degree in Life Science, Healthcare or Nursing 
  • Preferred Masters or Project Management Training 
  • Preferred working experience with dialysis or renal disease.  Experience with project management tools and best practices

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

56) Scientist – Contract (Southern California) 6075N73

DESCRIPTION:

  • The successful candidate will apply his/her in-depth knowledge in Molecular Biology and Cell Engineering to complete Services projects or to develop new platform technologies. 
  • Design, plan, and conduct laboratory experiments independently. 
  • Leading services projects. 
  • Training and guidance of other team members may be also required.
  • Scientist III level employees solve problems associated with their project through application and integration of analytical skills, creativity, and judgment utilizing appropriate scientific principles.
  • Will interact regularly with peers, subordinates, and functional peer groups, as well as customers and will present complex problems across functional areas. 
  • Will also write technical reports, develop protocols, and may give technical presentations to customers or at meetings.
  • All deliverables will impact business performance and operational efficiency.

EXPERIENCE AND QUALIFICATIONS:

  • Molecular Biology techniques and Stable Mammalian Cell Line Generation (Cell Engineering) is required. Hands–on training in qPCR, next generation sequencing, high throughput, and automation are desirable. 
  • Excellent organization and communication skills.
  • B.S. with 5 years of relevant experience, M.S. with 3 years of relevant experience, or Ph.D. in Molecular Biology or related discipline.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

57) Financial Analyst – Contract (Southern California) 73L4185

DESCRIPTION:

  • Maintaining the integrity of our financial systems through reconciling EDW to Hyperion Planning and troubleshooting disconnects.
  • Executing month end close activities which will include loading manual entries to EDW and reconciling sales, cost, OPEX and inventory transactions.
  • Support integrations activities e.g. loading AOP and historical sales data to EDW.
  • Driving process improvements through automating manual processes and making best use of our systems.
  • Providing end user training to EDW end users within Finance.
  • Working with IT to ensure key enhancements and defects are properly tested and deployed to our live systems, ensuring data integrity by developing effective controls, identifying issues and fixing at source system.
  • Driving process improvements through automating manual processes and making best use of our systems.

EXPERIENCE AND QUALIFICATIONS:

  • Experience as a user in Cognos/EDW.
  • An interest in learning how EDW is configured and interfaces with other systems such as E1/SAP and Hyperion Planning
  • Bachelors degree or the equivalent education and experience are required

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

58) Administrative Representative – Contract (New Jersey) 6222

DESCRIPTION:

  • Handles routine customer service inquires related to human resources, payroll and benefits administration and provides Knowledge Base Q&A support as needed. 
  • Opens tickets and logs calls into a computerized call tracking system . 
  • Answers questions by primarily relying on standard screens, scripts and procedures for call resolution. 
  • Works closely with the other components of the HR function to escalate cases and sufficiently address customer needs.
  • Answers general questions and redirects misplaced calls.
  • Uses procedures, policies, knowledge database and other reference materials to assist in answering employee, manager and agency HR, payroll or benefits representative inquires.
  • Guides employees and managers on using the on-line Knowledge Base tool.
  • Receives and processes employee data change requests or appropriately escalates issues.
  • Collects and validates complete data required to process manual employee personal and organizational transactions and escalates the completed data for processing.
  • Escalates complex issues/inquires to other parts of HR or redirects calls to ITS or other appropriate groups.
  • Provides support and coaching to peers.
  • Participates in continuous improvement workshops and project

EXPERIENCE AND QUALIFICATIONS:

  • Specific focus on bilingual French/English candidates.
  • High School Degree or equivalent work experience.
  • 1 or more years of general HR experience.
  • Ability to follow strict policy guidelines.
  • Ability to navigate computerized data entry system and other relevant applications.
  • Ability to recognize situations requiring call escalation.
  • Ability to follow standard procedures and scripts without variation.
  • HRIS experience preferred.
  • Strong oral communication skills.
  • Strong listening skills.
  • Strong customer service focus.
  • High School Degree or equivalent work experience.
  • French speaking is a "nice to have"

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

59) Clinical Research Associate II – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) VF132D

DESCRIPTION:

Responsible for implementing and monitoring clinical trials and expands experience in clinical trial and vendor management procedures.  Works closely with study coordinators and investigators to ensure compliance with protocol and overall clinical objectives.  Develops independence in performing routine work and develops leadership skills.  Identifies projects/tasks and works with Clinical Trial Manager to complete.  Develops ability to organize, manage and set priorities for multiple tasks.  Demonstrates ability to carry out all CRA I functions with minimal supervision.  In collaboration with manager and/or Lead CRA, maintains consistent CRF data quality and discrepancy interpretation across sites.  Uses an established understanding of the disease, molecule and indication.  

Responsibilities:
  • Conducts site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct
  • Co-monitors with more junior CRAs to assist manager/Lead CRA with on-site monitoring and study visit training, as needed
  • Assists in CRF design and CRF guidelines
  • Develops study tools and guidelines to be utilized by study sites
  • Assists in the process used to evaluate and select potential investigators and sites
  • Prepares monitoring reports per SOPs
  • Interacts with investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues and assigned sites
  • Presents at Investigator/Study Coordinator meetings and represents company in the technology booth at scientific meetings, as necessary
  • Understands study timelines and manages sites to meet timelines
  • Collaborates with team to maintain consistent CRF data quality and discrepancy resolution across sites
  • Proactively identifies and works to resolve enrollment and data completion issues
  • Performs manual, in-house review of CRF data in clinical database for completeness and accuracy
  • Reviews site’s informed consents against the consent template for presence of all GCP requirements and protocol specific information.  Reviews the consent for accuracy and ensures that the consent is written in language that subjects will understand
  • Develops basic skills in writing informed consent templates, protocol and other documents. Applies knowledge of regulatory requirements/SOPs to documents
  • Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy
  • Ensures study records are auditable both at investigational sites and in-house
  • Responsible for tracking IND Safety Reports for assigned sites
  • Initiates drug/device shipments and ensures that drug supplies are adequate for assigned studies
  • Assists manager/Lead CRA with the investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studies
  • Responsible for initiating and tracking quarterly site payments
  • Communicates status of trial to manager and team
  • Responsible for coordinating and leading various functional area projects and tasks
  • Develops basic skills in functional area team leadership
  • Partners with team members and other functional areas such as Regulatory, QA, Legal, Biometrics

EXPERIENCE AND QUALIFICATIONS:

  • Good verbal and written communication skills are required.  
  • Attention to detail and organizational skills
  • Working knowledge of GCP and FDA regulations
  • Proficiency in MS Word, Excel and PowerPoint
  • 2+ years of CRA experience in an industry setting, or four years of pharmaceutical/health care field experience including 1 year previous experience as a CRA.
  • Experience in clinical research at either a hospital or pharmaceutical/biotech company
  • BS/BA degree in a life science, RN, or related field

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

60) Associate Scientist I - R&D – Contract (San Francisco Bay Area) 73A9814

DESCRIPTION:

  • Candidate will join a team developing new molecular biology methods, chemistry and instrumentation. 
  • Duties are in line with general tasks performed by an R&D bench scientist. 
  • Conduct pre-designed scientific or engineering experiments in a molecular biology laboratory. 
  • Plan the use of equipment, materials and own time. 
  • Accuracy is required in performing all functions of this position. 
  • Make detailed observations and perform basic data analysis. 
  • Maintain complete and thorough lab notebook and training file. 
  • Advise team of factors that may affect quality, accuracy, timeliness and usefulness of data. 
  • Suggest options / ideas for additional experiments. 
  • Troubleshoot experiments with assistance from team. 
  • Contribute ideas and suggestions to improve standard laboratory techniques, improve protocols, processes and equipment. 
  • Assist in lab procurement, calibration or maintenance. 
  • Comply with all company safety regulations and procedures. 
  • With team’s guidance, become familiar with scientific processes and molecular mechanisms directly associated with the assigned project. 
  • May be required to perform other related duties as required and/or assigned. 
  • Position exercises judgment within defined procedures and practices to determine appropriate action. 
  • Normally receives general instruction on routine work, detailed instruction on new assignments. 
  • Job encounters recurring work situations with occasional variations from the norm, involving a moderate degree of complexity.  

EXPERIENCE AND QUALIFICATIONS:

  • Must have experience in molecular biology research including general molecular biology techniques, including following protocols, pipetting, quantifying DNA, calculating molarities, setting up reactions and PCR. 
  • Must have ability to perform experiments with high precision and accuracy. 
  • Must have experience accurately recording data, interpreting data, keeping a lab notebook, and reporting results. 
  • Must be an effective team player with strong spoken and written communication skills. 
  • Must be familiar with standard office software tools (Microsoft Word and Excel, or equivalents). 
  • Experience with TaqMan or other quantitative-PCR methods is desirable. 
  • Experience with genotyping is desirable. 
  • Experience with basic statistical methods is desirable.
  • Bachelor's degree in Biology, Chemistry, Biochemistry or other related discipline or the equivalent knowledge and experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

61) Light Industrial – Contract (Pennsylvania) 0787

DESCRIPTION:

  • Change-over equipment to run new products
  • Maintaining packaging equipment
  • Maintenance of existing packaging equipment
  • Supervise investigational product packaging operations for both primary and secondary packaging
  • Ensure equipment is running smooth and/or trouble shooting production equipment during daily use within the production cGMP area
  • Write SOPs relating to packaging equipment and implement validation plans for equipment as required. 
  • Assist Operations in liaising with vendors on tooling design development, approval, manufacture and implementation for all primary and secondary equipment.
  • May interact with other groups to develop packaging designs (eg. Communicate equipment constraints, tooling timelines, engineering design intricacies)
  • Interaction with the Label Printing department on label design
  • Unit-dose blister equipment: Klockner EAS and CP3 systems. Cold and thermoform.
  • Bottling Line for HDPE bottles: unscrambler, tablet filler, capper, induction sealer, retorque system.
  • Horizontal labeling systems for syringes and auto-injectors.
  • Vertical labelers for vials and bottles
  • In-line and rotary carding systems to seal unit dose blisters into a heat or cold seal application.
  • Label Printers-Zebra thermo-transfer used in the Label 

EXPERIENCE AND QUALIFICATIONS:


  • Experience with MS Word, and Excel is preferred.
  • Excellent written and oral communication skills are needed.  

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

62) Manager / Sr Manager CMC Project Management – Full Time (New York) XL130F

DESCRIPTION:

Summary: 

Using extensive CMC Project Management knowledge and experience in the drug development industry, the Manager/Senior Manager leads assigned CMC Projects that are typically of advanced complexity and large scope (such as Commercial or Late Clinical Phase in nature). The Senior Manager is expected to apply strong supervisory experience to lead and provide CMC expertise/guidance to assigned team members.

Responsibilities:
  • Leads the operational activities of cross functional teams and deliverables in a matrix organization in order to execute the development strategy for the assigned CMC Projects / programs. Drives the CMC Project / program’s evolution through completion within timeline, quality and budgetary constraints. Acts as a key resource for direct reports on matters related to CMC PM.
  • Acts as a key liaison in the interactions between company and our corporate partners. Prepares, provides input, and / or manages the process involving major presentations for joint collaboration meetings – effecting key business decisions. Responsible for facilitating and driving decision making in support of the joint strategic objectives of the program.
  • Develops an integrated CMC Project plan relevant to the team deliverables and ensures alignment across relevant functions and smooth transitions among pipeline stages. Leads annual goal setting sessions to develop CMC Project level milestones that contribute to the overall milestones and for monitoring progress against these goals. Plans contingency and risk mitigation planning. Oversees the development of integrated CMC Project plans and actively monitors progress against the approved baselines.
  • Demonstrates the ability to gain cooperation of others and effectively facilitates the resolution of cross-functional issues. Ensures effective, accurate and timely communication across functional areas within the CMC Project, serving as a primary point of contact for management within and outside the team regarding progress on CMC Project milestones. Communication responsibilities include but not limited to weekly/monthly project updates as well as project specific Technology Management Plans. Identifies and resolves any team and/or individual performance issues.
  • Creates, maintains and executes CMC Project plans, timelines, agendas, resourcing requirements, rolling summaries, base lining and other tools required to facilitate planning and coordination of deliverables for each assigned CMC Project.
  • Coordinates and leads communication between global functional areas and corporate partners where applicable. 
  • Coordinates activities for writing data summaries or presentations for joint collaboration meetings, etc.
  • Proactively identifies issues and provides general guidance to resolve CMC Project issues and develops solutions to meet productivity and quality milestones and objectives.
  • Develops tools and mechanisms for monitoring progress and problem solving with CMC Project and functional area managers. Defines and documents working / best practices that can be used across other CMC Projects with all relevant departments in order to ensure that product is efficiently supplied to all non-clinical, clinical, and commercial sites.
  • Requires a demonstrated ability to change the thinking of, or gain acceptance of others in sensitive situations and influences the overall objectives and long-range milestones of the CMC Project / program. Represents the department in relevant internal / external committees. Coordinate the CMC regulatory activities required for submission of license applications, INDs, and other regulatory documents to government agencies.
  • Ensures quality and timeliness of deliverables for projects are met.
  • Lead special projects as assigned by supervisor/department management.
  • Consistently demonstrates strong interpersonal skills and consistently nurtures productive relationships with internal and external customers.
  • Initiates and leads the decision-making and risk-management process. Trouble shoots and is proactive in dealing with EM-vendor / collaborator issues for individual and teams projects.
  • Ability to effectively deal with ambiguity and change.
  • Understands and motivates others and builds effective teams. 

EXPERIENCE AND QUALIFICATIONS:

  • Requires strong presentation and critical thinking skills.
  • Requires excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company in order to establish credibility with professionals on the CMC Project teams
  • Actively promotes constructive interactions among team members in order to address difficult situations. 
  • Resolves and negotiates conflicts or problems with tact, diplomacy and composure. 
  • Ability to handle multiple CMC Projects and priorities with exceptional organizational and time management skills (both CMC Project and self).
  • Title level (Associate Manager, Manager, or Sr. Manager) will be determined based on skills and experience.
  • Bachelor’s degree in any physical or Biological Science and 8+ years relevant progressive CMC Project Management experience and experience managing a team (direct reports) in the drug development industry, or Masters/PhD and 5+ years’ experience as listed above. 
  • PMP certified, MBA and experience managing project partners and collaborators considered a plus.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

63) Medical Writer – Contract (New Jersey) 6943

DESCRIPTION:

  • Coordinate the adboards activities for the medical team request across the different projects
  • Follow-up and coordinate the contracts request process
  • Interactions with HCP platforms for contracts request for regulated countries
  • Interactions with Key opinion leaders to prepare all the above steps
  • Next and Trace NP system (financing systems)
  • Follow-up and coordinate the Key Opinion Leaders’ invoices process
  • Support Key Opinion Leaders’ activities
  • Interact with the Key Opinion Leaders team
  • Participate to the Key Opinion Leaders team meetings and activities
  • Involve in congress symposium and scientific meeting preparation
  • Involve in medical educational programs
  • Involve in the management of the Key Opinion Leaders database

EXPERIENCE AND QUALIFICATIONS:

  • Experience in medical affairs activities such as organizing advisory boards, scientific meetings, symposia
  • Skills in medical writing
  • Medical/Scientific background
  • Experience in interactions with Key Opinion Leaders
  • Skills in project management and good communication
  • Experience in handling contracts and administrative tasks link to budget follow-up, monitoring experts expenses
  • PhD

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

64) Analytical Chemist – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) Z122EJ

DESCRIPTION:

  • The perfect candidate is detail oriented and fluent with concentration/dilution equations, RP-HPLC, and Waters Empower Software. 
  • Create standard curves with accuracy and precision; modify gradients to enhance performance.  
  • Approximately 75% of time will be spent in the laboratory.
  • Pre-validation method development
  • HPLC and UHPLC (C-18 RP-HPLC)
  • Size Exclusion (HPSEC)
  • Purity assays
  • Potency assays
  • Ultraviolet spectroscopy assay
  • Buffer preparations
  • Formulation stability study time points.
  • Ordering lab consumables.
  • Maintenance of Instruments / Calibration Documentation.
  • Formulation experiments
  • Aerosol test methods.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with Waters Empower Software is mandatory. 
  • Experience with RP-HPLC is mandatory
  • Biologics (protein) experience strongly preferred.
  • Solid understanding of pH and buffer systems is required.
  • QC background is a plus. 
  • GMP experience is required.
  • Must have excellent attention to detail and laboratory documentation skills
  • Flexibility/ experience in a start-up environment
  • Ability to work independently
  • BS/MS in chemistry or related life science with 5+ years’ experience or PhD with the lab skills but less experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

65) Sr QC Stabilty Associate / Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BL122T

DESCRIPTION:

  • Support stability studies for pharmaceutical products, evaluate stability data and draft stability reports. 
  • Manage and review raw data including HPLC.   
  • Review aerosol data for trending. 
  • Responsible for completing and reviewing laboratory documentation in a cGMP compliant manner and will also help review and approve laboratory data generated at CROs.
  • Interface with 2 to 5 contract laboratories to assure time points are pulled on schedule and data is collected.

EXPERIENCE AND QUALIFICATIONS:

  • Must have good knowledge and experience with general laboratory techniques, experience with data review and good general chromatography knowledge.
  • Must have good technical writing skills.
  • Must have good knowledge and understanding of GMP guidelines.
  • Management of CROs and direct report experience a plus.
  • Strong organizational skills
  • Experience in a start-up environment; Flexibility
  • Biologics and / or aerosol drug and/or medical device experience are desirable
  • Experience with device extractables, Rabbit potency test, and microbial testing laboratory data desirable
  • Experience with bottle containers or glass injection vials a plus
  • Mandarin written and verbal fluency is desirable
  • BS or higher in chemistry, biochemistry or related field or equivalent
  • 6 or more years pharmaceutical laboratory experience in a GMP environment

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

66) Patient Access Program Lead Pharmacist / Nurse – Contract (Massachusetts) 6123

DESCRIPTION:

  • Oversee processing of patient drug access requests globally
  • Monitoring medical review of cases and facilitating external expert review
  • Review of all solid organ transplant (SOT) inventory requests
  • Primary liaison to external Expert Advisory Panel
  • Primary liaison to US program administrator
  • Point of triage for US HCP inquires and SOT HCP inquiries globally
  • Support ongoing process improvement
  • Ensuring regular reporting of raw and aggregate metrics
  • Providing guidance for implementation of online ordering

EXPERIENCE AND QUALIFICATIONS:

  • Pharmacy/Medical/Clinical experience, Project Management
  • PharmD w/ 5+yrs experience or Registered Nurse w/5+yrs

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

67) Sr. Project Manager / Associate Director, Oncology – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) P113FX

DESCRIPTION:

  • Responsible for the execution of high quality project management to ensure the achievement of clinical development goals consistent with the product development objectives. 
  • The DPM manager will report into the Assoc. Director/Director and will be responsible for providing project management expertise to cross-functional development sciences project teams. 
  • Responsibilities and deliverables include project plans, timelines, budgets, and high quality team performance.
  • Develop and manage project plans and timelines for assigned studies in accordance with project goals
  • Lead clinical study teams throughout the study planning, conduct, data management, and close out phases.
  • Manage the monthly budgeting process, including forecasting and variance analysis.
  • Ensure high quality team performance by providing problem solving and decision making guidance to teams.
  • Develop and maintain strong, collaborative relationships with key stakeholders and organization.
  • Serve as a lead point of contact or manager of vendors and collaborators.
  • Contribute to the implementation of new project management processes and policies to advance growth and development of the DPM function.

EXPERIENCE AND QUALIFICATIONS:


  • Project Management, organization and planning, problem solving, decision making, communication and influence, teamwork and collaboration
  • Extensive knowledge of overall drug development process relevant to pharmaceutical/biotech organizations and roles for the various functional areas within clinical development.
  • Strong financial acumen; capable of planning and providing oversight of project budgets budget.
  • Strong timeline development and management experience; MS Project experience preferred.
  • Excellent oral, written, interpersonal, and organizational skills.
  • Attention to detail.
  • Demonstrated excellence in managing multiple projects in different clinical phases (I–IV).
  • Knowledge of Good Clinical Practices (GCP) and application to the conduct of Oncology global clinical studies.
  • 5-8 years experience in a Biotech or Pharmaceutical/CRO organization of which 3-5 years have been spent in project management or program management in Oncology drug/diagnostic development
  • A Bachelor of Science required. 
  • Masters or comparable experience in Oncology drug/diagnostic development or the Oncology scientific/clinical field highly desired. 
  • Certification or professional training in project management would be a plus

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

68) Associate Director / Director Regulatory Affairs – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) RF133J

DESCRIPTION:

  • Reporting to the Senior Vice President of Regulatory and Compliance, the Associate Director/Director of Regulatory Affairs is responsible for leading activities of Regulatory Affairs with emphasis on global regulatory strategy and the preparation, review and submission of documents to FDA and other regulatory authorities
  • Provides current regulatory intelligence and formulates regulatory strategies.
  • Oversees implementation of regulatory strategy and activities needed to secure approval of new drugs.
  • Oversees coordination, preparation and timely submission of regulatory documents.
  • Maintains current knowledge and expertise of FDA/EMA regulations and ICH guidelines.
  • Provides regulatory advice to other functional areas.
  • Serves as a principal interface with reviewers from FDA and other health authorities
  • Identifies perceived gaps in product development plans that may pose regulatory issues
  • Participates in regulatory due diligence activities.
  • Develops and maintains relationships with external vendors and regulatory health authorities.
  • Coordinates preparation of responses to queries from regulatory authorities.
  • Coordinates activities pertaining to meetings and conferences with FDA, EMEA, and other regulatory authorities
  • Maintains relationships and collaborates with partners to improve effectiveness in regulatory strategies.
  • Mentors department personnel and updates appropriate departments on the current regulatory environment.
  • Supervises employees, consultants/contractors in Regulatory Affairs
  • Optimizes employee performance by developing employees and promoting career growth.
  • Develops and implements regulatory operating guidelines and common work practices/strategies within the team.

EXPERIENCE AND QUALIFICATIONS:

  • Extensive experience in drug development and approval process (INDs, NDAs, MAAs) across all phases of development.
  • Demonstrated ability to interpret and stay current with FDA and other regulatory agency regulations and guidelines.
  • Experience with eCTD requirements and electronic submissions
  • Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions.
  • Demonstrated knowledge of regulatory aspects of Chemistry, Manufacturing and Controls and quality assurance, is a very strong plus.
  • International experience is desired
  • Orphan drug experience is a plus
  • Experience with labeling requirements is a plus
  • Demonstrated management expertise, including leadership and development of employees.
  • Ability to work effectively across teams, functions and with outside partners.
  • Excellent oral and written communication skills.
  • Excellent organizational skills and attention to detail.
  • 10+ years of drug development and regulatory affairs experience in the Biotech/ Pharmaceutical industry.
  • Advanced degree MD, Pharm.D. or Ph.D. preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

69) Sr. Product Data Steward – Contract (Southern California) 73J1917

DESCRIPTION:

  • Administration of the change control system consists of initiating and tracking all incoming, in-process and completed change requests, tracking all associated supporting documentation and following up to ensure the changes are completed and documentation is properly closed out.
  • Responsible for project managing the process of change control:
  • Communicates with internal customer to collect product related information
  • Manages the change request workflow, which is the vehicle to send request for changes
  • Manages the change workflow, which is the vehicle to execute the request for changes
  • Maintains accurate records of all in-process Product change orders & Document Change Orders (admin function)
  • Provides end-users status updates on their requests
  • Executing product data changes for approved changes orders in site support systems
  • Runs report and queries related to the change management activities
  • Responsible for all changes related to sku discontinuation
  • Initiate Master Data updates as necessary, ensuring completion of corrections.
  • Maintain Quality Records in compliance with ISO Standards.
  • As necessary, evaluates ERP system data to verify accuracy.
  • Will take part in mass data updates as well as ERP system and report modification testing.
  • Provide OJT Training for new team members.
  • May be required to perform other related duties as required and/or assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Works independently on new and on-going assignments
  • Identifies and solves problems using established business rules and procedures
  • Detail oriented
  • Good verbal and written communication skills
  • Continuous improvement minded
  • Comfortable with ambiguity and change
  • Requires a minimum of 2 – 4 years relevant experience in a data management, manufacturing, planning, or quality role in a change control environment.  
  • Knowledge of computer applications and current software is desirable (Microsoft Excel, Outlook, Word, Access, Project and PLM/ERP system
  • Associate’s degree from accredited college/university or equivalent experience.  
  • Applied technical knowledge of PLM and ERP/MRP systems is preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

70) Regulatory Operations Associate – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A111JP

DESCRIPTION:

  • Reports to the Associate Director of Regulatory Operations. 
  • Responsible for the day-to-day support of paper and electronic submissions to Global Regulatory Health Authorities (i.e., FDA, Health Canada, EMA, China SFDA, etc.).
  • Will play a key role in the development of regulatory infrastructure (databases, systems, and tools) used to support the day-to-day department activities. This role will be integral in the roll out and management of eCTD submissions, including the development of its processes.
  • Responsible for the oversight and administration of the Regulatory Archiving Inbox.
  • Supports daily submission activity, including (but not limited to) the assembly of Regulatory Submissions to US FDA in both paper and electronic eCTD format.
  • Supports ex-US submission activity to global health authorities, including (but not limited to) the preparation, formatting, and QC of documents being submitted global health authorities in the Asian and EU regions through CROs and Partners.
  • Review and format document according to Regulatory Operations standards. 
  • Troubleshoot and resolve complex document issues.
  • Gather information in support regulatory submissions for drugs products.
  • Maintain and fix Regulatory System and Database issues (e.g., SharePoint and MS Access).
  • Responsible for the Regulatory Archiving Inbox. Duties include archiving all Health Authority communications received for global health authorities either directly or from affiliates. 
  • Plays an integral role in the QC of Regulatory Documents and Submissions.
  • Provides support and training on custom authoring and formatting tool.
  • Contributes toward the development and implementation of department-wide SOPs, policies and/or work processes to streamline all submission activities and standardize interactions with other departments
  • Assists in typing, formatting, editing, proofing, creating and manipulating complex tables, converting text and graphics, scanning, bookmarking and hyper linking.
  • Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
  • Provides oversight and participates in the maintenance of the submissions archive room and electronic submission repositories

EXPERIENCE AND QUALIFICATIONS:

  • Strong technical skills, including knowledge of IT systems and document management concepts.
  • Proficiency in relevant systems and software, including eCTD software, Document Management Systems, MS Access, SharePoint, Microsoft Office, and Adobe Acrobat
  • Familiarity with FDA requirements for regulatory submissions (such as eCTD)
  • Outstanding interpersonal, planning and organizational skills
  • Have a passion for quality and an impeccable detail orientation
  • Excellent writing, verbal communication skills and proven successful management abilities
  • Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects
  • 1-2 or more years of pharmaceutical industry experience
  • 1-2 or more years in regulatory affairs, with demonstrated ability to interact successfully with team members and health authorities where appropriate
  • Bachelor's degree and/or equivalent work experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

71) Senior Manager Development Sciences Operations Process Improvements and Analytics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) RG113T

DESCRIPTION:

  • Supports clinical development teams and management with insights, business intelligence, and performance metrics for effective decision making and process improvements. 
  • Supports development sciences functions by acting as a liaison between project teams, management, and technology management groups for process improvement initiatives and analytics. 
  • Leads continuous improvement projects that  support achievement of development sciences goals.
  • Oversees all aspects of selection, building, deployment, and implementation of a metrics dashboard and associated metrics tools
  • Design and oversee data analysis activities providing business context and industry insights to help organization make data driven process improvement decisions
  • Provide interpretation of KPIs, metrics, and analytics to answer key business questions
  • Support study team activities, operating reviews, and management requests through the delivery of information and performance metrics
  • Plan and oversee metric data analysis activities providing business context and industry insights to help the organization make data driven process improvements
  • Lead cross-functional teams to develop and implement clinical development process improvement initiative
  • Drive development of innovative solutions and process improvements through benchmarking and performance management
  • Coach, motivate, and provide career and technical advice to direct reports and others in department

EXPERIENCE AND QUALIFICATIONS:

  • Experience with biotech or pharmaceutical industry benchmarking and developing metrics within a performance management framework
  • Experience and proven track record with process improvement including process mapping within a formalized methodology (i.e. six sigma, LEAN, etc.)
  • Demonstrated project management skills; proven ability to manage multiple tasks to conclusion, on time, and without compromise to quality of work output
  • Cross-functional understanding of drug development processes
  • Experience presenting data and findings to executives and other leadership teams
  • Previous management experience of direct reports
  • Demonstrated ability leading cross-functional teams in the development of complex processes and metrics
  • Strong facilitation and writing skills, and effective problem-solving and interpersonal skills.
  • High degree of customer sensitivity and acumen.
  • Knowledge of IT systems and databases
  • Excellent organizational skills and attention to detail.
  • Highly proficient with project management tools and processes (e. g. MS Project, PowerPoint, Visio), as well as word processing, presentation and spreadsheet applications.
  • Experience with formal methodologies including Business Analysis, PMP, Balanced Scorecard, LEAN, BPMN, Data Analysis
  • BA/BS/BSc or RN with 9 years of experiences in the sciences, technology, or medically related field including 6 years of biopharmaceutical clinical development (clinical research of clinical operations experience obtained at a biotech, pharmaceutical, CRO, or industry supplier company) and 5 years of analytics experience working with a variety of data sources including data from clinical trial systems supporting study design, planning, startup, conduct and closeout
  • PMP Certification and/or certification in an established process improvement methodology preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

72) Senior Manager Project and Clinical Process Analytics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) RG113T

DESCRIPTION:

  • Supports clinical development teams and management with insights, business intelligence, and performance metrics for effective decision making and process improvements. 
  • Supports development sciences functions by acting as a liaison between project teams, management, and technology management groups for process improvement initiatives and analytics. 
  • Leads continuous improvement projects that  support achievement of development sciences goals.
  • Oversees all aspects of selection, building, deployment, and implementation of a metrics dashboard and associated metrics tools
  • Design and oversee data analysis activities providing business context and industry insights to help organization make data driven process improvement decisions
  • Provide interpretation of KPIs, metrics, and analytics to answer key business questions
  • Support study team activities, operating reviews, and management requests through the delivery of information and performance metrics
  • Plan and oversee metric data analysis activities providing business context and industry insights to help the organization make data driven process improvements
  • Lead cross-functional teams to develop and implement clinical development process improvement initiative
  • Drive development of innovative solutions and process improvements through benchmarking and performance management
  • Coach, motivate, and provide career and technical advice to direct reports and others in department

EXPERIENCE AND QUALIFICATIONS:

  • Experience with biotech or pharmaceutical industry benchmarking and developing metrics within a performance management framework
  • Experience and proven track record with process improvement including process mapping within a formalized methodology (i.e. six sigma, LEAN, etc.)
  • Demonstrated project management skills; proven ability to manage multiple tasks to conclusion, on time, and without compromise to quality of work output
  • Cross-functional understanding of drug development processes
  • Experience presenting data and findings to executives and other leadership teams
  • Previous management experience of direct reports
  • Demonstrated ability leading cross-functional teams in the development of complex processes and metrics
  • Strong facilitation and writing skills, and effective problem-solving and interpersonal skills.
  • High degree of customer sensitivity and acumen.
  • Knowledge of IT systems and databases
  • Excellent organizational skills and attention to detail.
  • Highly proficient with project management tools and processes (e. g. MS Project, PowerPoint, Visio), as well as word processing, presentation and spreadsheet applications.
  • Experience with formal methodologies including Business Analysis, PMP, Balanced Scorecard, LEAN, BPMN, Data Analysis
  • BA/BS/BSc or RN with 9 years of experiences in the sciences, technology, or medically related field including 6 years of biopharmaceutical clinical development (clinical research of clinical operations experience obtained at a biotech, pharmaceutical, CRO, or industry supplier company) and 5 years of analytics experience working with a variety of data sources including data from clinical trial systems supporting study design, planning, startup, conduct and closeout
  • PMP Certification and/or certification in an established process improvement methodology preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

73) Admininistrative / Professional – HR – Contract (New Jersey) 1265

DESCRIPTION:

  • Primary duties include compiling Excel spreadsheets, gathering data from multiple sources, analyzing data, and providing metrics for department dashboard.  
  • Incumbent will be required to review data for trends and make suggestions for process improvement.  
  • Duties may include running data integrity audit reports and/or performing manual audits of data entry transactions in SAP.

EXPERIENCE AND QUALIFICATIONS:

  • Expert Excel wizard with a background in metrics and analytics.
  • Preferred: Neocase Software, Microsoft Report Builder, PowerPoint, Visio, Sharepoint
  • Bachelor's Degree preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

74) Senior Project Manager / Associate Director – Contract to Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) G137AP

DESCRIPTION:


  • Assembling/ refining the Microsoft timeline and plan for a NDA submission
  • Tracking inputs needed for NDA submission and working with team members and regulatory to provide required sections in a timely fashion
  • Calendaring meetings, generating agendas and minutes, distributing materials for review with deadlines, tracking review progress and decisions, coordinating and documenting approvals, and maintaining a repository of approved materials.
  • Closely and transparently managing the critical path of the project.
  • Collaborating with cross-functional stakeholders to identify strategic and operational risks to timelines and deliverables to create appropriate mitigation and contingency plans.

EXPERIENCE AND QUALIFICATIONS:


  • Demonstrated judgment in selecting methods and techniques for obtaining solutions.
  • Strong influencing skills:  proven ability to get things done without formal authority.
  • Ability to work effectively with cross-functional teams.
  • Late stage drug development and Regulatory (NDA) submission experience required.
  • Oncology and commercial launch experience is a plus.
  • Highly proficient in MS Office Suite (Excel, MS Project, PowerPoint).
  • Proven Ability to work independently.
  • Bachelor’s Degree required.  Scientific degree preferred.
  • Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
  • A minimum of 5 years of Project Management experience supporting cross functional drug development teams in the pharmaceutical/biotech industry is required

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

75) Scientist (BS or MS) – Contract (Pennsylvania) 7455

DESCRIPTION:

  • Responsible for authoring documents (protocols, reports, risk assessments) and assembling data packs.   
  • Must have the ability to address and incorporate  comments from team members in a timely fashion.   
  • Must be pro active in scheduling meetings to resolve issues for timely document closure.   
  • The position will support execution of approved protocols.  
  • The candidate should have sample management experience.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent writing and interpersonal skills.
  • Must be well organized and be able to lead meetings and resolve conflict.
  • Excellent communication skill
  • MS Office 2010, LIMS, eDoc, MS Project, and Outlook are a must.  
  • BS/BA in Life Sciences, Chemistry, or Engineering

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

76) Regulatory Affairs, CMC Manager / Sr. Manager – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) X113PD

DESCRIPTION:

  • Reports to the Director, Regulatory Affairs, CMC
  • Proactively managing CMC aspects of one or more global commercial programs including overseeing preparation and submission of global CMC applications (marketing and clinical trial applications)
  • Provide responses to regulatory authority questions.
  • Ensuring that CMC content is accurate, complete, well-written, and meets all relevant requirements.  
  • Representing the Regulatory Affairs CMC function on assigned cross-functional project teams. 
  • Evaluating proposed manufacturing changes for global impact to ongoing and existing filings, and providing strategic regulatory guidance for optimal implementation of changes.  
  • Managing interactions with FDA or other regulatory authorities for assigned projects.   
  • Developing excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with commercial biological drugs required.
  • At least 1 year of previous supervisory experience managing associate(s) is required. 
  • Thorough understanding of relevant drug development regulations and guidelines is essential.
  • Prior success filing marketing applications, supplements, and variations for biologic products within timelines is required; global submission experience desired.
  • Experience in assessing post-approval changes is required.
  • Outstanding interpersonal and communication (written and verbal) skills is required.
  • Strong writing and editing skills for technical documentation.
  • Proficient with computer and standard software programs.
  • Able to travel 10%.
  • BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable.  Advanced degree is a plus.
  • 4-6 years of experience in Regulatory Affairs in a global pharmaceutical and/or biotechnology company with expertise in biologics and deep experience in commercial products as well as Phase 1-3. 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

77) Medical Director, Clinical Development – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) GF129B

DESCRIPTION:

  • Hands-on participation in the clinical program and trial development process - conceive and execute clinical strategy and provides clinical expertise for the research and development project 
  • Serve as the Medical Monitor for clinical trials (Phase 1 and Phase 2) 
  • Lead preparation of clinical sections of all relevant documents and regulatory filings (Investigator brochure, IND, study reports, etc)
  • Interact with key opinion leaders to assure implementation of latest clinical thinking and guidelines into the clinical development plan 
  • Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources 
  • Interact in collaborations with strategic partners 
  • Represent the company at scientific, commercial and financial community meetings and presentations, as well as other public relations opportunities 
  • Responsible for clinical development plan in highly competitive therapeutic areas 
  • Provide input/review study start up documentation, e.g. CRF design, source data verification plans based on protocol specifications 
  • Attend and provide science support for investigator and consultant meetings and other study implementation workshops 
  • Manage studies and provide expertise on clinical and medical issues to other colleagues and study site staff  
  • Review study data 
  • Evaluate Serious Adverse Events (SAEs) and provide input on safety reports 
  • Author clinical sections for final study reports 
  • Participate in preparation for submission activities as appropriate 
  • Assists in the development of publications, abstracts, and presentations 

EXPERIENCE AND QUALIFICATIONS:

  • Experience in small molecule clinical development preferred 
  • Ability to direct strategic interactions and partnerships with outside collaborators, such as academic research groups, corporate partners, CROs and other vendors
  • Reputation as a leader in the field with sustained performance and accomplishments as evidenced by quantity and quality of publications, patents, regulatory filings and/or other technical documents
  • Proven abilities in the review and interpretation of complex scientific data in order to form appropriate clinical opinions 
  • Strong interpersonal, team and collaborative skills, ability to function and influence effectively in a broad multidisciplinary group; consistently looking for win-win solutions to problems 
  • Passion for continued learning and mentoring 
  • Results-oriented self-driven and motivated individual who enjoys the immediacy of personal effort and impact 
  • MD with experience in the pharma/biotech industry conducting, interpreting human clinical studies with 5 or more years of experience 
  • Board eligibility/certification in hematology and/or oncology preferred 
  • Knowledge of or experience in hematologic malignancies strongly preferred 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

78) Clinical Assistant – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) M111YV

DESCRIPTION:

  • Provide support and assistance to the clinical operations team in the implementation and management of clinical trials.
  • Set-up and maintain all study and clinical operations files for assigned clinical studies
  • Route, track, and receive all essential clinical documents and business with CROs, other departments, sites, partnership collaborations, and vendors  
  • Maintain study documents, binders, manuals, and supplies to ensure adequate inventory for clinical operations and clinical sites 
  • Assist in the set-up and coordination of clinical activities and meetings, prepare meeting minutes as requested  
  • Maintain databases and tracking systems and review reports from various data sources (including the Clinical Trial Management System).  
  • Maintain quality records and documentation for ensuring compliance with FDA regulations, ICH guidelines, and company SOPs and guidelines  
  • Assists with preparing for meetings such as investigator meetings, partner meetings, scientific meetings as requested  
  • Works with supervisor and clinical operations team to achieve corporate goals and departmental goals within the expected time frames  
  • Assisting other departments, e.g. QA and/or RA, as needed with the Document Control System and regulatory submissions

EXPERIENCE AND QUALIFICATIONS:

  • Strong computer skills (MS Office) including the ability to create tracking systems and spread sheets  
  • Good working knowledge of FDA & ICH/GCP regulations and guidelines  
  • Strong analytical and assessment skills; good solving problems  
  • Organized and flexible team player that is able to asses priorities, multi-task, and meet deadlines  
  • Takes direction well and is able to understand and complete tasks under minimal supervision and with a high degree of accuracy and quality  
  • Ability to work under pressure and proactively identify issues with a solutions-oriented approach
  • Bachelor’s degree  
  • 1 year of clinical research experience working at a clinical trial site, CRO

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

79) Senior Director / Director, Program Management – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) CY127F

DESCRIPTION:

Summary

Will oversee, organize and shape commercial and development programs to ensure that all milestone requirements are met per agreed upon project specifications, costs, resources and on time and working with team, offers creative solutions to mitigate risk and solve problems. Sets agenda and chairs recurring program management cross functional meetings, ensures effective cross functional communications are achieved with all team members. The Project Manager highlights risks, timeline delays and other issues to Senior Management.  Previous commercial product experience required, global experience preferred.


Responsibilities
  • Oversees program plan development, tracks and updates milestones and key activity streams that enable the cross-functional project teams to meet objectives
  • With team members and in accordance with corporate objectives, facilitate the setting of program objectives, key milestones and scope
  • Develops detailed project plans including milestones, timelines, develop proactive corrective action plans for resolution of problems or issues, anticipation of problems, and facilitation of scope management
  • Leads team meetings and ensures that clear actions and decisions are documented, communicated and committed to, enabling timeline achievement
  • Minimizes extraneous information and reduces non-essential communications 
  • Act as central point of contact for program management 
  • Anticipates project challenges and risk scenarios and prepares/leads and executes proactive mitigation strategies 
  • Utilizes project metrics and ensures personnel understand status and critical attention areas
  • Builds strong working relationships across departments, with key stakeholders, and Senior Management to ensure transparency and to facilitate communication.

EXPERIENCE AND QUALIFICATIONS:

  • Prior international and global experience preferred 
  • Direct experience managing development timelines and budgets from development through commercial launch. Demonstrated competency in managing multiple projects in different phases, and in different regions.  
  • Ability to work independently as well as part of a multi-functional program team  
  • Must be willing and able to travel on a periodic basis, up to 20%
  • Must be well versed in project management tools and must possess knowledge of related disciplines
  • Computer proficiency in Microsoft Word, MS Project, Excel, and Outlook
  • Bachelor’s degree in a biological science is preferred
  • 5+ years’ of pharmaceutical industry experience with at least 3 years of hands-on experience as a program manager responsible for program management.  
  • Prior commercial experience required

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

80) Quality Compliance Team Lead (Asso Dir/ Director) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JY131K

DESCRIPTION:

Summary:

Leads the QA Compliance Department and is responsible for helping interpret cGMP regulations and current industry practices for Pharma Operations. This includes adherence to Quality System and Regulatory standards, internal audits, supplier quality, third party cGMP evaluations and approval, hosting health authority inspections and all validation programs.  Oversees/manages the compliant state of affairs for all GMP activities and areas with respect to current Good Manufacturing Practices, and other federal regulations, and company policies/procedures.
Responsibilities:
  • Ensure that all activities associated with commercial product are performed according to the local Quality System and SOP’s. 
  • Responsible for the overall GMP compliance for the facility, along with Reg CMC activities to ensure compliance with filed product, post market surveillance and activities (e.g. complaint handling).  
  • Responsible for FDA and other HA compliance by making sure that quality systems are in place, and monitoring adherence.
  • Direct the compliance programs for all cGMP areas including commercial product, including production, QA/QC, Engineering/Site Services/Logistics and Pharmaceutical Technology/Contract Manufacturing Support at the sites. This includes internal / external audits (e.g. PAI, biennial, self-audits, suppliers), Third Party cGMP evaluations and approval, Change Control management and all validation programs.
  • Responsible for the device release and quality oversight of device manufacture (in relation to the commercial combo products) and will be responsible for DMR, DHR, DHF, device release, validation, deviation investigation and change controls in accordance with ISO 13485, Standards, and Health Authority regulations.
  • Responsible for products which have been released and remaining on the market meet all specifications and regulatory requirements.
  • Interprets current Good Manufacturing Practices (cGMPs) for the site and evaluates procedures relative to FDA / EU and industry standards.  Recommends changes where appropriate.  
  • Serves as key resource person during inspections in Pharma Operations.  Evaluates and/or recommends corrective actions with regard to health authority inspectional observations.
  • Where relevant, ensures a contract quality agreement program is in place for third party facilities, testing labs, complaint evaluation, investigations, equipment qualification and validation (e.g. process, cleaning, and computer validation).
  • Monitor all PharmOps Key Quality Indicators (KQI). 
  • Participate in site Quality Review Board.   
  • Responsible for ensuring that the site is in a constant state of being inspection ready.
  • Responsible for setting and achieving Quality and Compliance yearly objectives, and adhering to budgets.
  • Responsible that all individuals in compliance have appropriate education, experience, training, and procedures to complete their responsibilities.
  • Responsible for ensuring compliance with Federal (FDA), State and local regulations.  Ensure and monitor adherence to all company policies and procedures relating to cur-rent Good Manufacturing Practices
  • Responsible for liaising with the Site Validation Master plan coordinator in order to ensure all commercial validation and qualification activities are addressed, and making sure the individual commercial Master Plans are in line with the Site master plan. 
  • Provides final approval for Standard Operating Procedures, GMP Training Documenta-tion, Change Control, Validation Documentation for Production, Lab, IT (GMP systems), investigation and final batch release (as backup for QA). 
  • When permitted, has designated signature authority for Quality Head.

EXPERIENCE AND QUALIFICATIONS:

  • Working knowledge of local and global regulations and submission and approval processes for New Chemical Entities (NCE) and product life cycle management.
  • Proven track record of successfully working in inter-disciplinary teams and of simultaneously planning, coordinating and leading activities on multiple projects or equivalent experience from external company or other line function.
  • Regularly demonstrated active contributions to line functions or project teams, e.g. change or site transfer teams as well as ability to contribute to matrix teams with the necessary strategic thinking.
  • Computer literacy in MS Project, PowerPoint, document management systems, databases and ability to quickly learn new software, tracking tools and associated processes.
  • Excellence in negotiation and communication skills as well as capability to influence others in a matrix organization.
  • Excellent organizational skills.
  • Proactive and action-oriented attitude in driving projects.
  • Ability to represent the site in cross functional teams.
  • A minimum of 10 years of related pharmaceutical experience.
  • A minimum of 7 years experience working on a manufacturing site (e.g. QA, QC or production) or laboratory or equivalent experience from external company or other line function preferable.
  • A minimum of a Bachelor Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
  • Advanced degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent is preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

81) Senior Manager/Associate Director, Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) K111DN

DESCRIPTION:

Support the manufacture of Drug Substance and Drug Product at Contract Manufacturing Organizations (CMO) and Contract Research Organizations (CRO) to ensure products are in compliance with Good Manufacturing Practices (GMP) and are of the appropriate quality for their intended use. The position involves managing quality operations with CMO/CRO, and liaison of quality related issues with Chemistry, Manufacturing and Control (CMC) Team and functional areas.

Responsibilities

  • Must have the ability to execute QA tasks independently, effectively represent QA in CMC team setting, and interface with CMO/CRO.
  • Review Drug Substance/Drug Product master and executed batch records
  • Review clinical packaging/labeling master and executed batch records
  • Manage CMO/CRO change control, deviation & CAPA systems
  • Conduct supplier audits
  • Maintain and improve quality systems
  • QA review of test method validation/transfer
  • QA review of equipment/instrument qualification
  • Represent QA in cross-functional projects
  • Assume tasks in quality assurance area as required

EXPERIENCE AND QUALIFICATIONS:

  • Must be familiarity with quality management of solid dosage forms (tablet, capsule)
  • Experienced in conducting GMP audits
  • Quality control and/or analytical development background helpful
  • Small molecule synthesis and purification knowledge desirable
  • Working knowledge in CMC process
  • Good interpersonal and writing skills
  • Self motivated, independent, and collaborative
  • Travel required (around 20%)
  • 10+ years of quality assurance background in pharma/biotech industry, with hands-on role in quality operations and quality systems
  • 3+ years hands-on QA experience in working with CMO/CRO
  • B.S./M.S. in relevant science field

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

82) Senior Manager / Associate Director, Clinical Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) AL111H

DESCRIPTION:

Support the Clinical Quality Assurance program. The incumbent will conduct and manage Good Clinical Practice (GCP) related quality audits (e.g., investigator site and vendor qualification); support development and improve the existing GCP related quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures and protocols. The incumbent is also responsible for developing specific internal procedures, training of staff and hosting regulatory inspections. The position involves managing global clinical quality operations and liaison of clinical quality related issues with functional areas.

Responsibilities:

  • Must have the ability to execute CQA tasks independently; effectively represent QA in a GCP driven team setting and interface with clinical vendors, investigator sites and regulatory agencies.
  • Must actively participate in sustaining a level of inspection readiness of clinical stakeholders and act as a catalyst for continuous process improvement.
  • Develop GCP related quality system SOPs in compliance with all applicable regulatory requirements and to align with existing company policy.
  • Ensure clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements.
  • Manage/conduct quality audits of investigator sites and various clinical vendors.
  • Manage/conduct quality audits of clinical study documents, which include investigator brochures, clinical protocols and clinical study reports, case report forms and informed consents forms.
  • Manage/conduct internal audits to ensure stakeholder system compliance with existing policies and procedures, and GCP requirements, standards and guidelines.
  • Provide expert CQA advice to stakeholders (e.g., Clinical Operations, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of GCP regulations.
  • Support the administration of the company’s training program by conducting GCP training to internal departments and externally, as applicable.
  • Manage/conduct targeted training of investigators/site staff.
  • Report GCP related deficiencies to QA management as well as plans for corrective and/or preventive actions (CAPA).
  • Assist clinical study teams in the development of CAPAs.
  • Assist with tracking GCP compliance audit trends and group metrics and presenting metrics driven data to upper management.
  • Coordinate responses to regulatory agency inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research.
  • Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
  • Position requires a highly diplomatic, tactful and detail oriented individual with exceptional critical reasoning skills.
  • Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways
  • Ability to deal with ambiguity, creative and pragmatic approach to problem solving
  • Travel will be required between 30 to 50% of the time
  • Auditor and/or GCP certifications a plus
  • 10+ years of progressive global quality assurance background in pharma/biotech and medical device industries, with a hands-on role in quality operations and quality systems
  • 5+ years hands-on CQA/GCP Compliance experience
  • B.S./M.S. in relevant science field

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

83) Associate Director / Director, Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) W111EC

DESCRIPTION:

The position involves managing quality operations with CMO/CRO, and liaison of quality related issues with Chemistry, Manufacturing and Control (CMC) Team and functional areas with focus on Oral solid dosage form products.
The successful candidate must have the ability to execute QA tasks independently, effectively represent QA in CMC team setting, and interface with CMO/CRO.

Responsibilities
  • Review Drug Substance/Drug Product master and executed batch records
  • Review clinical packaging/labeling master and executed batch records
  • Manage CMO/CRO change control, deviation & CAPA systems
  • Conduct supplier audits
  • Maintain and improve quality systems
  • Test method validation/transfer
  • Equipment/instrument qualification
  • Represent QA in cross-functional projects
  • Assume tasks in quality assurance area as required

EXPERIENCE AND QUALIFICATIONS:

  • 10+ years of quality assurance background in pharma/biotech industry, with hands-on role in quality operations and quality systems
  • 3+ years hands-on QA experience in working with CMO/CRO
  • B.S./M.S. in relevant science field
  • Quality control and/or analytical development background helpful
  • Small molecule synthesis and purification knowledge required
  • Understanding of oral dosage forms technology (tablet, capsule) required
  • Working knowledge in CMC process a plus
  • Good interpersonal and writing skills
  • Self motivated, independent, and collaborative
  • Some travel may be required

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

84) Senior Scientist (Process Chemical Development) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) PH111X

DESCRIPTION:

  • Reporting to the Department Senior Director, the successful incumbent will work on all process chemistry aspects of new small molecule pharmaceuticals
  • Designing, proving in the laboratory, developing, and optimizing GTI free synthetic organic processes/procedures to prepare new small molecule drug substances
  • Timely internal preparation of appropriate quantity and quality small molecule drug substances, intermediates, reference materials, metabolites, impurities, and degradation products
  • Assisting in isolation and identification of impurities and modifying processes to control impurity levels
  • Assisting in oversight of CMO activities related to technology transfer, development, optimization, scale-up and manufacture of drug substance and related materials
  • As needed, providing on-site monitoring of drug substance manufacturing at contract sites, and support of investigations and deviations
  • Reviewing, verifying and approving process documentation and batch records for cGMP drug substance manufacturing
  • Regularly reporting work status and preparing written reports on work performed
  • Reviewing drug substance documentation and reports for technical accuracy in support of regulatory filings
  • Cooperatively working with personnel in other departments: Analytical Development, Formulation Development, Medicinal Chemistry, Quality Control, Quality Assurance, Regulatory Affairs, and Project Management

EXPERIENCE AND QUALIFICATIONS:

  • Able to design synthetic routes and complex procedures for defined compounds
  • Analytical skills such as HPLC, GC, LC-MS, NMR, FTIR, DSC
  • Experienced writing reports on synthetic processes
  • Team player with ability to positively communicate with team members
  • Knowledge and understanding of cGMP regulations and ICH guidance
  • Knowledge and understanding of the CMO industry and sources of commercial chemicals
  • Experience with chemical scale-up, manufacturing batch record preparation, technology transfers, and knowledge of larger scale GMP chemical synthesis
  • Hands-on experience with pilot plant scale-up and/or larger scale chemical synthesis desirable
  • Ability to manage multiple projects simultaneously and work independently under limited supervision
  • Proficiency with word-processing, spreadsheet, chemical drawing, statistical, and project management software (i.e. MS Word, Excel, ChemDraw, JMP or Design Expert, MS Project)
  • PhD in synthetic and/or mechanistic organic chemistry
  • At least 8 years experience with 5+ years in chemical process development of small molecules and in developing and optimizing chemical processes

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

85) Chemical Engineer – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) H111BC

DESCRIPTION:

  • Reporting to the Department Senior Director, the successful incumbent will focus on process safety, scale up manufacturing and process validation associated with new small molecule pharmaceuticals
  • Working in multi-functional teams to develop scalable processes which supplies API for safety testing, clinical trials and formulation development.
  • Supporting API projects through all phases of development (Phase I to Process Validation including commercial manufacturing).
  • Assisting in oversight of CMO activities related to technology transfer, optimization, scale-up and manufacture of drug substance
  • Ensuring that CMO is managing material handing appropriately and that processes are run safely
  • Providing significant support for process validation projects including criticality assessment, writing/reviewing process validation documentation, and process validation execution.
  • As needed, providing on-site monitoring of drug substance manufacturing at contract sites, and support of investigations and deviations
  • Reviewing, verifying and approving process documentation and batch records for cGMP drug substance manufacturing
  • Regularly reporting work status and preparing written reports on work performed
  • Reviewing drug substance documentation and reports for technical accuracy in support of regulatory filings
  • Cooperatively working with personnel in Chemical Development and with personnel from other departments: Analytical Development, Formulation Development, Quality Control, Quality Assurance, Regulatory Affairs, and Project Management

EXPERIENCE AND QUALIFICATIONS:

  • Skills focused on optimization of unit operations such as reactions, distillations, extractions, membrane separations, chromatography, crystallization, centrifugation, filtration, drying and milling.
  • A technical background in kinetics, thermodynamics, fluid mechanics, mass transfer and heat transfer.
  • Experience writing technical reports
  • Analytical skills are desirable, such as HPLC, GC, NMR, microscopy, FTIR, DSC, and/or on-line techniques
  • Team player with ability to positively communicate with team members
  • A basic understanding of government regulation such as FDA cGMPs, ICH guidance EPA hazardous waste regulations, local and federal environmental regulations, and OSHA chemical hygiene plans.
  • Knowledge and understanding of the CMO industry and sources of commercial chemicals
  • Experience with transfer, scale-up and process validation of chemical processes to commercial facilities
  • Hands-on experience with pilot plant scale-up and/or larger scale chemical synthesis desirable
  • Ability to analyze extensive data sets and communicate a summary of their analysis effectively
  • Proficiency with word-processing, spreadsheet, chemical drawing, simulation/modeling, statistical, and project management software (i.e. MS Word, Excel, ChemDraw, Dynochem, Vismix, Aspen, CFD, JMP, Design Expert, MS Project).
  • PhD in Chemical Engineering
  • At least 5+ years in chemical engineering associated with development of pharmaceutical small molecules

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

86) Scientist / Senior Scientist, Analytical Development (Small Molecules) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) AL111W

DESCRIPTION:

  • Develop methods for characterizing and release testing of small molecule drug substance and drug product therapeutics. 
  • Develop methods, qualify, and validate methods and transfer methods to QC for QC testing. 
  • Provide analytical support to chemists performing process development activities. 
  • In addition to strong chromatography and mass spectrometry skills, experience with dissolution testing, particle size measurements, NMR, FTIR, DSC, TGA, ICP, XRPD, and other analytical techniques are a plus.
  • Developing and optimizing HPLC methods to report impurities and assay of small molecule drug substances and drug products
  • Qualification and validation of methods and transfer of methods to QC
  • Working with contract laboratories
  • Writing protocols and reports suitable for regulatory submissions

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated expertise with HPLC methodologies is required.
  • Experience with mass spectrometry is required.
  • Experience and knowledge of method qualification and validation is necessary.
  • Strong communication skills, verbal and written, and a team-oriented approach are required.
  • Will be organized, self-motivated, and able to work both independently and as part of a team.
  • Excellent writing skills are required.
  • BS or MS with a minimum of 6+ years of industry experience or equivalent, or a PhD with a minimum of 2+ years of industry experience is required. Title will be dependent upon experience level.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

87) Scientist / Senior Scientist, Analytical Development (Biologics) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) G111RY

DESCRIPTION:

  • Develop capillary electrophoresis methods for characterizing and release testing of a monoclonal antibody therapeutic. 
  • Develop methods, qualify, and validate methods and transfer methods to QC for QC testing. 
  • Use CE methodologies to characterize micro-heterogeneities in the monoclonal antibody. 
  • Experience with HPLC, mass spectrometry, and other analytical techniques are a plus.
  • Developing and optimizing cIEF and CE-SDS methods
  • Qualification and validation of CE methods and transfer of methods to QC
  • Characterization of micro-heterogeneities by CE methodologies
  • Writing protocols and reports suitable for regulatory submissions

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated expertise with capillary electrophoresis methodologies (cIEF, CE-SDS, CZE, QIAxcel) is required.
  • Experience and knowledge of method qualification and validation is necessary.
  • Experience with monoclonal antibodies (mAbs) is required.
  • BS or MS with a minimum of 6+ years of industry experience or equivalent, or a PhD with a minimum of 2+ years of industry experience is required. Title will be dependent upon experience level.
  • Strong communication skills, verbal and written, and a team-oriented approach are required.
  • The successful candidate will be organized, self-motivated, and able to work both independently and as part of a team.
  • Excellent writing skills are required.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

88) Clinical Pharmacologist – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A133GB

DESCRIPTION:

  • Reporting to the SVP, Clinical Research and Development, the Medical Director will be responsible principally for early clinical drug development activities with a strong focus on Phase I and Phase IIa clinical trials.  
  • Will work closely with members of the R&D team to ensure a strategic view is taken for the pipeline progression of individual projects. 
  • In collaboration with others in Clinical Research and Development, design and execute clinical studies (ADME, special populations, pharmacokinetic, and pharmacodynamic) to support existing and new compounds in development.
  • Responsible for the medical oversight and conduct of clinical pharmacology studies
  • Identify, evaluate, and interact with clinical study sites including assessment of strengths and weakness of medical functions  
  • Responsible to contribute to, review, and finalize clinical study reports of clinical pharmacology studies
  • Interact with regulatory authorities as required in support of ongoing development programs 
  • Medical monitor in sponsored studies as appropriate, ensure that the clinical teams correctly handle all adverse events (AEs) and serious adverse events (SAEs) in accordance with ICH standards 
  • Correctly apply the ICH and GCP regulations surrounding the primary activities of clinical development projects 
  • Operate within the time and budget constraints of the clinical program 
  • Communicate project-related information, including responsibility for planning and preparation for meetings and presentations 
  • Coordinate and complete scientific documents including protocols, clinical study reports, other regulatory documents
  • Collaborate with biometrics, bioanalysis, and clinical operations to achieve study objectives
  • Interact effectively with counterparts at collaboration partners to accomplish company objectives related to strategic partnerships  

EXPERIENCE AND QUALIFICATIONS:

  • Randomized controlled clinical trial principles, methodology and procedures 
  • Adverse medical event investigation, analysis, as well as reporting procedures and standards 
  • Extensive knowledge of clinical pharmacokinetics and modeling principals
  • FDA and EMA regulatory requirements and ICH/GCP guidelines is an asset 
  • Federal and state regulations and guidelines pertaining to the conduct of clinical trials on human subjects 
  • Statistical data collection, editing, validation and analysis techniques 
  • Current and developing trends and standards in clinical trials monitoring 
  • Industrial standards as applied to GCP and GLP 
  • Infrastructure and operational characteristics of Contract Research Organizations (CROs) and centralized clinical laboratories 
  • Ability to develop and implement clinical research protocols and study specific procedures 
  • Ability to communicate, interact and present competently and professionally both verbally and in writing at all levels within a broad, complex clinical research environment including third parties such as partners, CRO’s, and academia 
  • Travel up to 30% as necessary according to project needs
  • Registered Medical Doctor (mandatory qualification) 
  • Board certification/specialist registration in clinical pharmacology highly desirable or significant prior relevant experience
  • 7-10 years of experience in drug development in the pharmaceutical and/or biotech industry, covering both early and translational phase development or significant participation in industry sponsored research as a clinical investigator
  • PhD in clinical pharmacology would be an asset 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

89) CRA I /II – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) S117JT

DESCRIPTION:

  • Responsible for implementing and monitoring clinical trials and expands experience in clinical trial and vendor management procedures.  
  • Works closely with study coordinators and investigators to ensure compliance with protocol and overall clinical objectives. 
  • Identifies projects/tasks and works with Clinical Trial Manager to complete.  
  • Demonstrates ability to carry out all CRA I functions with minimal supervision.  
  • In collaboration with manager and/or Lead CRA, maintains consistent CRF data quality and discrepancy interpretation across sites.   
  • May conducts site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct
  • Develops study tools and guidelines to be utilized by study sites
  • Assists in the process used to evaluate and select potential investigators and sites
  • Interacts with investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues and assigned sites
  • Understands study timelines and manages sites to meet timelines
  • Collaborates with team to maintain consistent CRF data quality and discrepancy resolution across sites
  • Performs manual, in-house review of CRF data in clinical database for completeness and accuracy
  • Reviews site’s informed consents against the consent template for presence of all GCP requirements and protocol specific information. 
  • Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy; Ensures study records are auditable both at investigational sites and in-house
  • Responsible for initiating and tracking quarterly site payments

EXPERIENCE AND QUALIFICATIONS:

  • Verbal and written communication skills are required.  
  • Attention to detail and organizational skills
  • Working knowledge of GCP and FDA regulations
  • Proficiency in MS Word, Excel and PowerPoint
  • 2+ years of CRA experience in an industry setting, or four years of pharmaceutical/health care field experience including 1 year previous experience as a CRA.
  • Experience in clinical research at a pharmaceutical/biotech company; 
  • BS/BA degree in a life science, RN, or related field

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

90) (Senior) Associate Manager CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) MA132W

DESCRIPTION:

  • Responsible for supporting the CMC regulatory strategy and coordinating the process for compiling CMC section of regulatory submissions.
  • Reviews CMC documentation to ensures they meet regulatory requirements.
  • Coordinates CMC regulatory  workflow between departments as well as CROs
  • Coordinates and compiles CMC document packages and investigational drug shipment related activities for drug manufacturing according to regulations/guidelines and company SOPs
  • Assembles, coordinates and compiles  technical documents needed to complete CMC section of regulatory submissions.
  • Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the area of small molecule pharmaceuticals.
  • Assists in the coordination of drafting of responses to regulatory questions in a timely manner.
  • Assists in the review of change controls and provides regulatory impact assessment as needed. 
  • Escalates issues that affect registration, and regulatory compliance to CMC Regulatory Affairs Management

EXPERIENCE AND QUALIFICATIONS:

  • Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
  • Proficient with computer (MS Office) and internet skills.
  • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted activities, demanding regulatory requirements, commitment to highest quality and the requirements of pharmaceutical partnering are absolutely necessary.
  • Proven ability to communicate with executive management, cross-functional team members and operational staff.
  • Flexible attitude with respect to work assignments, and new learning.
  • 1 to 6 years relevant regulatory CMC  experience
  • BS in Chemistry; Advanced degree preferred. (MS, PhD or PharmD or equivalent)

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

91) Sr Manager , Scientific & Technical Publishing – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R132GL

DESCRIPTION:

Summary:

Responsible for the publication of regulatory documents according to regulatory authority specifications and department standards for paper and electronic submissions. Assists in the development of electronic submissions standards and tools.  The Manager/Sr. Manager, Regulatory Publishing also coordinates the review and revision of all regulatory documents for submission to regulatory agencies.  This position generally receives no instruction on routine work but detailed instruction on new assignments.

Responsibilities:
  • Integrates data from various electronic or paper sources into either electronic or paper submissions using format and style essential for regulatory compliance with established operating procedures, and current medical and technical writing standards. 
  • Must collaborate effectively with contract team members to publish, copy, assemble, quality check, and publish required documents.  
  • In addition, he/she will continue to develop expertise through participation in both internal and external technical training. 
  • Demonstrate proficiency in required software.
  • Provide word processing, advanced formatting, and publishing assistance to Regulatory and Clinical personnel.
  • Create and maintain templates for regulatory submissions.
  • Assist in maintenance of Regulatory archives.
  • Assist with the incorporation of document comments from multiple reviewers including text, graphs, charts, tables and statistical analysis
  • Review documents for format compliance to current style guidelines and correct deficiencies within timeline
  • Assist with the coordination of regulatory document routing, revision tracking, proof-reading, and document approvals
  • May perform additional tasks and duties as assigned

EXPERIENCE AND QUALIFICATIONS:

  • Basic understanding of the US, EU, and ICH regulations and guidelines.
  • Demonstrated proficiency in MS Office including advanced use of styles, automated table of contents and cross-references, version control, change tracking, indexes, styles, macros, charts and embedded graphics, forms and toolbars; assist in bookmarking, hyperlinking, and compiling electronic submissions within Adobe Acrobat.
  • Strong technical background including proficiency in document publishing, desktop publishing, scanning, Microsoft Office, Adobe Acrobat, PowerPoint, standard graphics and publishing software, Endnote, MS Project, etc.
  • Follow proofreading marks, use accepted styles and terminology, provide limited copyediting.
  • Ability to work independently with minimal supervision.
  • Strong interpersonal skills.
  • Demonstrated verbal and written communication skills.
  • Ability to multi-task, pay close attention to detail, and follow projects through to completion.
  • Excellent organizational, prioritization, and planning skills.
  • 6-8 years related experience in publication and scanning of assorted documents or images supporting regulatory submissions; requires previous experience in regulatory submissions, license applications, etc., within the pharmaceutical, biotech, or related field.
  • Bachelor’s degree desired or equivalent relevant experience in Regulatory Publishing

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

92) Lab Tech – Contract (Texas) 5531M73

DESCRIPTION:

  • Carry out standard operating procedures involving materials measurement, materials handling and inventory control, equipment operation and record keeping necessary to manufacture product batches as instructed. 
  • Record keeping includes but is not limited to Batch Data Records, notebooks, customer reports and work order documents. 
  • Maintain accurate inventory of products and inventory records using the Materials Resource Planning tools (i.e. issuing materials to work orders, completing products to inventory, kitting, closing, transfers, returns, expensing of raw materials, WIP and finished product). 
  • Complete production and quality analysis of reagents, components and finished products in accordance with the Production Schedule. 
  • Communicate manufacturing problems to manufacturing management and the team and assist in identifying variables and offering resolutions. 
  • Keep manufacturing supervisors and team members informed on the status of assigned production processes. 
  • May train other team members on techniques and processes. 
  • Complete all batch data records completely, according to Quality Systems standards as required.
  • May perform other related duties as required and/or assigned. 
  • Interacts with equivalent levels of personnel in the manufacturing area. 
  • The job encounters semi-routine work situations of limited scope and complexity where ability to recognize deviation from accepted practice is required.  
  • The incumbent normally receives general instructions on routine work and detailed instruction on new assignments.

EXPERIENCE AND QUALIFICATIONS:

  • Accuracy is required in performing all functions of this position; errors in work could cause delays in schedules.
  • Effectiveness in this role requires a functional knowledge of applicable manufacturing process and Standard Operating Procedures and the ability to consistently and accurately follow procedures.
  • Good oral and written communication skills are required to communicate work status and problems. 
  • High school diploma required; technical training in manufacturing preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

93) Senior Medical Director, Drug Safety – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) P111BL

DESCRIPTION:

  • Provide global medical leadership and input into all aspects of safety of assigned molecule or therapeutic area including surveillance programs, aggregate review and risk management planning.
  • Proactive safety review of aggregate safety data including signal detection
  • Support clinical team in developing safety section for protocol, informed consent, and investigator brochure
  • Participate in activities related to Independent safety data monitoring committee (ISDMC)
  • Analyze integrating safety data from completed clinical studies
  • Review and provide input on the safety section for clinical study reports
  • Develop strategy and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committee
  • Ensure timely preparation for risk management strategies (RMP, REMS), including risk minimization measures
  • Timely preparation of periodic reports (DSUR)
  • Maintain compliance with corporate policies, standard operating procedure and global regulation
  • Lead the discussion on safety issue cross-functionally
  • Participate in development, review and update of safety exchange agreement with collaborators
  • Prepare and participate in regulatory review meetings
  • Participate in audits and inspection
  • Prepare and share safety information with licensing partners, review safety documents prepared by licensing partners, communicate safety matters with partners per the safety data exchange agreement
  • Provide training, coaching and mentorship to safety scientists
  • Represent and champion the role of safety in the organization

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of processes and global regulations governing pharmacovigilance and risk management
  • Drug development
  • Safety data capture
  • MedDRA and other dictionary used in pharmacovigilance
  • Knowledge of methods of qualitative and quantitative safety data analysis
  • General medicine, epidemiology, physiology and pharmacology
  • Signal detection, aggregate data analysis and evaluation
  • Good clinical and scientific judgment
  • Strategic thinking and leadership
  • Effective team work, influencing and negotiation in a cross-functional environment
  • Ability to work with collaborators and licensing partners
  • Good organizational skills,
  • Strong leadership ability in negotiation, communication and networking
  • Problem solving
  • Develop solutions in coordination with key decision makers
  • Executes goals and department strategy
  • Detailed knowledge of current pharmacovilance environment, regulations and processes
  • MD, DO or equivalent from accredited medical school
  • 7+ years in the pharmaceutical or biotech industry
  • 5+ years in drug safety and pharmacovigilance
  • Experienced managing/supervising staff

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

94) Medical Director, Drug Safety – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) TM111Z

DESCRIPTION:

  • Provide global medical leadership and input into all aspects of safety of assigned molecule or therapeutic area including surveillance programs, aggregate review and risk management planning.
  • Proactive safety review of aggregate safety data including signal detection
  • Support clinical team in developing safety section for protocol, informed consent, and investigator brochure
  • Participate in activities related to Independent safety data monitoring committee (ISDMC)
  • Analyze integrating safety data from completed clinical studies
  • Review and provide input on the safety section for clinical study reports
  • Develop strategy and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committee
  • Ensure timely preparation for risk management strategies (RMP, REMS), including risk minimization measures
  • Timely preparation of periodic reports (DSUR)
  • Maintain compliance with corporate policies, standard operating procedure and global regulation
  • Lead the discussion on safety issue cross-functionally
  • Participate in development, review and update of safety exchange agreement with collaborators
  • Prepare and participate in regulatory review meetings
  • Participate in audits and inspection
  • Prepare and share safety information with licensing partners, review safety documents prepared by licensing partners, communicate safety matters with partners per the safety data exchange agreement
  • Provide training, coaching and mentorship to safety scientists
  • Represent and champion the role of safety in the organization

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of processes and global regulations governing pharmacovigilance and risk management
  • Drug development
  • Safety data capture
  • MedDRA and other dictionary used in pharmacovigilance
  • Knowledge of methods of qualitative and quantitative safety data analysis
  • General medicine, epidemiology, physiology and pharmacology
  • Signal detection, aggregate data analysis and evaluation
  • Good clinical and scientific judgment
  • Strategic thinking and leadership
  • Effective team work, influencing and negotiation in a cross-functional environment
  • Ability to work with collaborators and licensing partners
  • Good organizational skills,
  • Strong leadership ability in negotiation, communication and networking
  • Problem solving
  • Develop solutions in coordination with key decision makers
  • Executes goals and department strategy
  • Detailed knowledge of current pharmacovilance environment, regulations and processes
  • MD, DO or equivalent from accredited medical school
  • 5+ years in the pharmaceutical or biotech industry
  • 3+ years in drug safety and pharmacovigilance

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

95) Director CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) XF132H

DESCRIPTION:

  • Responsible for ensuring the CMC regulatory strategy is in alignment with the global regulatory strategy and leading and coordinating the  process for compiling the CMC section of regulatory submissions.
  • Work with cross-functional project teams to develop CMC regulatory strategy and ensure success of regulatory filings.
  • Reviews CMC documentation to ensures they meet regulatory requirements.
  • Represents RA CMC  at project team meetings and coordinates regulatory  workflow between departments as well as CROs
  • Coordinates, writes, compiles  CMC  document packages and investigational drug shipment related activities  for  drug manufacturing  according to regulations/guidelines and company SOPs
  • Participates in specification committee meetings and reviews/approves specification changes.
  • Assembles, coordinates and compiles technical documents needed to complete CMC section of regulatory submissions.
  • Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the area of small molecule pharmaceuticals.
  • Coordinates drafting of responses to regulatory questions in a timely manner.
  • Reviews Change controls and provides regulatory impact assessment. Ensures appropriate regulatory filings are completed in a timely manner.
  • Participates in Regulatory Affairs initiatives to improve standards and systems.
  • Escalates issues that affect registration, and regulatory compliance to CMC Regulatory Affairs Management

EXPERIENCE AND QUALIFICATIONS:

  • Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
  • Proficient with computer (MS Office) and internet skills.
  • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted activities, demanding regulatory requirements, budgetary responsibility, commitment to highest quality and the requirements of pharmaceutical partnering are absolutely necessary.
  • Proven ability to communicate with executive management, cross-functional team members and operational staff.
  • Flexible attitude with respect to work assignments, and new learning.
  • 8+ years relevant regulatory CMC  experience
  • BS and advanced degree in life sciences (MS, PhD or PharmD or equivalent)

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

96) Manager / Sr. Manager CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) B132WN

DESCRIPTION:

  • Responsible for ensuring the CMC regulatory strategy is in alignment with the global regulatory strategy and lead/coordinate the process for compiling CMC section of regulatory submissions.
  • Reviews CMC documentation to ensures they meet regulatory requirements.
  • Represents RA CMC at project team meetings and coordinates regulatory  workflow between departments as well as CROs
  • Coordinates, writes, compiles CMC document packages and investigational drug shipment related activities for drug manufacturing  according to regulations/guidelines and company SOPs
  • Assembles, coordinates and compiles  technical documents needed to complete CMC section of regulatory submissions.
  • Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the area of small molecule pharmaceuticals.
  • Coordinates drafting of responses to regulatory questions in a timely manner.
  • Assists in the review of change controls and provides regulatory impact assessment as needed. 
  • Ensures appropriate regulatory filings are completed in a timely manner.
  • Participates in Regulatory Affairs initiatives to improve standards and systems.
  • Escalates issues that affect registration, and regulatory compliance to CMC Regulatory Affairs Management

EXPERIENCE AND QUALIFICATIONS:

  • Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
  • Proficient with computer (MS Office) and internet skills.
  • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted activities, demanding regulatory requirements, commitment to highest quality and the requirements of pharmaceutical partnering are absolutely necessary.
  • Proven ability to communicate with executive management, cross-functional team members and operational staff.
  • Flexible attitude with respect to work assignments, and new learning.
  • 6+ years relevant regulatory CMC  experience
  • BS in Chemistry. 
  • Advanced degree preferred. (MS, PhD or PharmD or equivalent)

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

97) Director / Sr. Director, Regulatory Affairs – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) G129FS

DESCRIPTION:

Responsible for global regulatory leadership, management and strategic guidance for all regulatory aspects (nonclinical , clinical, CMC) of one to two development stage programs. The responsibilities of this position include defining, implementing and delivering the global regulatory strategy for assigned programs. The individual must possess a thorough knowledge of global rules, regulations, and guidances governing drugs and biologics in all phases of development and be able to provide guidance in interpreting these rules, regulations, and guidelines. Strong leadership, communication (written and verbal), and management skills are required with a hands-on, can-do attitude.

Responsibilities:
 
  • Develop and implement U.S. and ex-U.S. regulatory strategies and act as a regulatory lead to ensure that all activities are conducted in compliance with relevant laws, regulations, and guidance including with manufacturing, research, clinical, and quality assurance.
  • Act as the primary contact for regulatory licensing matters.
  • Review labeling and promotional materials throughout the product lifecycle and communicate labeling changes to all stakeholders.
  • Interact cross-functionally with members of commercial, legal, safety, clinical, manufacturing, quality, medical, and others
  • Plan, coordinate and prepare documents that are submitted to US and international regulatory authorities in support of INDs, BLAs, DMFs CTAs, NDAs and necessary amendments, safety reports, and annual updates.
  • Ensure that regulatory expectations are clear to all internal and external stakeholders (including partners, CROs, consultants and contractors) in order to execute program objectives in compliance with applicable regulations.
  • Represent the Company externally in scientific, financial and business development communities, and in meetings with regulatory agencies serve as a credible, influential, respected corporate spokesperson during all interactions with regulators and regulatory agencies.
  • Ensure regulatory submissions are completed on time by working with project teams to gather the information and documents necessary to file complete and accurate submissions in accordance with corporate goals.
  • Continue positive communications and rigorous interaction with the FDA and other regulatory agencies and ensure activities meet all relevant requirements & guidelines.
  • Identify potential compliance issues and work with respective functions in developing corrective action plans to ensure compliance is achieved.

EXPERIENCE AND QUALIFICATIONS:

  • BS, MSc, or Ph.D. degree in the life sciences with a minimum of 15+ years in drug development in the pharmaceutical/biotechnology industry in the regulatory function.
  • Large Molecule/ biologics experience required
  • Thorough knowledge of global rules, regulations, and guidances governing drugs and biologics in all phases of development.
  • Experience with planning and filing license applications (NDA, BLA, MAA). 
  • Experience with electronic submissions is desired.
  • Must have experience filing a minimum of one license application.
  • Working knowledge of FDA regulations is required as well as experience supporting global clinical studies.  
  • EU experience preferred
  • Experienced self-motivated individual with a record of achievement as a result of past initiatives in submitting successful IND9S) to NDA(s)
  • Regulatory experience in the review of labeling and promotional material.
  • Willingness to handle day-to-day functions while still providing the high-level strategic guidance.
  • Open, available, transparent communicator, able to develop a culture of teamwork and collaboration.
  • Able to develop and maintain excellent working relationships with global health authorities
  • Experience working with project teams and will be well versed in regulatory terminology with the ability to communicate with experienced regulators in the various governmental agencies.
  • Must possess strong leadership, presentation and influence skills.
  • Must possess excellent written and verbal skills (articulate and persuasive).
  • Able to advance group goals to meet company objectives.
  • Able to provide expertise in shaping company direction.
  • Experience at small or start-up company.  
  • Ability to be both strategic and hands on.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

98) Associate Director / Sr. Manager Clinical Supply Chain – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JQ111V

DESCRIPTION:

Ensures that all clinical trials have timely and adequate supply for administration to subjects. The Clinical Supply Chain group is involved in a clinical trial from the early stages of inception to study closure. The AD role includes demand forecasting, determination of an appropriate presentation to the clinical site and subject, setting production schedules, inventory management at depots and sites, order management and proof of delivery, and return or destruction. Additionally the manager implements and ensures group compliance to procedures for the production and distribution of investigation product. Mentor junior colleagues in the team when needed.

Responsibilities:
  • Interpretation of a protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time managing clinical labeling including label design and manufacturing        
  • Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts
  • Importing and exporting clinical trial material.
  • Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution 
  • Setting up Integrated Voice and Web Response Systems with the clinical team.
  • Interfacing between the CMC and clinical teams.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with clinical blinding practices.
  • Experience setting up Integrated Voice and Web Response Systems.
  • Working knowledge of drug development process (Phase I-IV).
  • Working knowledge of cGMPs.
  • Experience with clinical labeling, packaging and distribution including cold chain, importing and exporting
  • Strong analytical and problem solving skills.
  • Ability to handle multiple projects simultaneously.
  • Proven project management skills.
  • Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization.        
  • Use of Microsoft Office including Word, Excel, PowerPoint, Visio and Microsoft Project.
  • BS/BA degree.
  • Minimum 3 - 9+ years industry experience in clinical operations or supply chain management. 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

99) Sr Clinical Supply Chain Coordinator – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R132BN

DESCRIPTION:

Summary:
Manage global clinical drug supply activities such as secondary packaging vendor selection, technical batch record review, clinical label design, label translation coordination, packaging and labeling, IXRS oversight, distribution tracking, product returns and destruction coordination.  Manage secondary packaging vendors to ensure timelines are met.  Provide Supply updates at weekly Study Management and Vendor Team meetings. 

Responsibilities:
  • Supply support for Clinical Operations
  • Manage select clinical drug supply activities
  • Provide supply input on study protocols
  • Identify secondary packaging suppliers based on clinical product requirements
  • Attend weekly Study Management Team meetings
  • Conduct weekly vendor update calls
  • Provide status updates to Clinical Operations
  • Coordinate clinical label text review and approvals
  • Coordinate clinical label translations for global studies
  • Perform technical packaging batch record review
  • Oversee packaging at secondary packaging sites
  • Ensure packaging timelines are met
  • Ensure products are released by required dates
  • Coordinate product shipment/transfers with vendors and Logistics
  • Temperature excursion management/evaluation
  • Coordinate post study product return activities
  • Update/develop required Clinical Drug Supply SOP’s
  • Establish Clinical Supply set up requirements
  • Generate required SOP’s

EXPERIENCE AND QUALIFICATIONS:

  • Previous Clinical Drug Supply experience required
  • Understanding of cGMP’s and pharmaceutical industry procedures and regulations.
  • Ability to plan, budget and organize.
  • Strong, open and transparent communication skills (verbal and written).
  • Solid organizational and time management skills.
  • Project management skills and computer proficiency.
  • Experience with:  MS Excel, Word, Project.  
  • Bachelor’s degree in business or biological sciences with minimum of 5 years experience in GMP supply chain or pharmaceutical program management.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

100) Associate Scientist II - R&D – Contract (San Francisco Bay Area) 1144F73

DESCRIPTION:


  • Create new SKUs using SKU wizard
  • ECO request of new part release through Agile
  • Write processing documents
  • Support work related to SAP and Agile database
  • Work with various stakeholders: following up the progress of ECO, and facilitating the resolution of any issues.
  • Support Tech Transfer group in lab testing of assays.

EXPERIENCE AND QUALIFICATIONS:

  • Familiar and experienced with SAP and Agile.  
  • If only experienced in SAP, familiar in general ERP system to be trained on Agile quickly. 
  • Basic knowledge in ERP system is must.
  • Requires a Bachelor's degree in Biology, Chemistry, Biochemistry, or other related discipline, or the equivalent knowledge and experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

101) Technical Writer – Contract (Pennsylvania) 4062

DESCRIPTION:

  • Technical writing and updating of cGMP documents.  
  • Driving a document through review and approval states, which means dealing with other support groups.
  • Able to complete assigned tasks independently

EXPERIENCE AND QUALIFICATIONS:

  • In depth knowledge of MS Office Programs
  • Microsoft word – high skill level (technical editorial support)
  • TrackWise – Global and North American
  • SAP experience
  • Detail oriented
  • edoc experience preferred
  • Articulate communication skills
  • College degree preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

102) Associate Director QC Team Lead – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A131AF

DESCRIPTION:

  • Plans, controls and directs QC testing operations for all product dosage forms. 
  • Oversees/manages facility/equipment utilization relative to compliance of current manufacturing processes/procedures with current Good Manufacturing Practices, health, safety and environmental policies and other federal regulations, and company policies and procedures.
  • Oversight of commercial stability programs, including activities conducted at third parties, to ensure compliance with policies.
  • Plans, organizes and directs the activities of all QC product testing functional areas, to assure that the materials released from the laboratories comply with internal and regulatory requirements, and that agreed upon target dates for work are met.
  • Oversight of third party laboratory operations to ensure compliance with policies.
  • Establishes and maintains proper compliance with cGMPs, as well as corporate/departmental SOPs (cGMP and safety); included are review of procedures to assure complete and accurate testing records, adherence to SOPs, lab failure investigations and reporting procedures.
  • Establishes QC product testing departmental objectives, establishes long-term strategy and resources requirements, and periodically reviews progress toward reaching goals, with ultimate responsibility for meeting those objectives.
  • Approves specifications/control procedures for all products and components; approves operations and QC validation protocols and reports (analytical, cleaning, process computer).
  • Helps create department and corporate quality-related policies and procedures.
  • Establishes and fosters a positive continuous improvement mentality leading to the implementation of best industry practices.
  • Interacts with the FDA, trade associations, and professional groups
  • Represents QA/QC on key cross-functional product and/or process teams and special corporate task forces.
  • Serves on all key quality-related corporate committee including recall, NORMS and GMP.
  • Ensures that all Product Testing associates have the appropriate education, experience and training (cGMP, safety, technical) to effectively, efficiently and safely complete their responsibilities.
  • Assist the Head of Quality to establish operating and capital budgets; manages operating expense budget.
  • Manage deviation and OOS process and assist in resolution.
  • Performs other duties as may be required or necessary.
  • On time delivery of analytical results
  • Laboratory compliance – deviations and audit observations
  • QC Productivity
  • On time completion of stability
  • Customer service level
  • QC compliance with training requirements

EXPERIENCE AND QUALIFICATIONS:

  • Experience with inhalation products; Chemistry background REQUIRED; small molecule experience required
  • Experience leading a GMP commercial lab operation
  • Thorough knowledge of analytical principles, methodologies, and techniques utilized in the pharmaceutical QC environment.  
  • Thorough knowledge of operational functions of production, packaging, technology/MPS, materials management.
  • Thorough understanding of budgeting principles, resource management, and goals/objective setting and implementation.
  • Auditing and technical report writing experience.
  • Expert knowledge and understanding of GMPs, keeping up to date with current industry issues and changing regulations. 
  • Experience in Deviation Management and batch disposition.
  • Experience in Change Control, validation and APR/PQR.
  • Experience with health authorities audits.
  • Proven experience with Lean, 5S, Opex, IQP applied principles
  • Very good user knowledge for Microsoft Word and Excel, SAP and Trackwise.
  • Excellent oral and written communication skills required.
  • Demonstrate leadership ability and excellent interpersonal skills.  
  • Ability to work under minimal direction, independently or as part of a team if necessary.
  • A minimum of 10 years of related pharmaceutical experience.
  • A minimum of 8 years of managerial experience in a QA/QC organization.
  • Bachelors degree in a scientific discipline is required; Advanced degree is preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

103) Patent Attorney, Director – Full Time (New York) XA130J

DESCRIPTION:

  • The candidate will function as a legal director for dispute resolution
  • Play a key role in the company’s IP enforcement strategies, including managing independently or as part of a team with other law department colleagues pharmaceutical global contentious patent proceedings, including but not limited to pharmaceutical/ biotechnology patent litigation in the US and in Europe. 
  • Manage outside counsel in non-patent litigation as needed; flexibility is required. 
  • Experience with ex parte and/or inter partes reexaminations and ex-US invalidation and opposition proceedings is a plus. 
  • The candidate will report to the Senior Director of Intellectual Property. 
  • Must be willing and able to interact and communicate well with upper management and help develop and advocate for the company’s perspective in global patent enforcement strategies with outside counsel, manage and guide outside counsel effectively, and work with counsel to manage litigation discovery. 
  • Independence and the ability to view litigation from a global perspective with the company’s long-term perspective and critically assess and direct outside counsel are important. 

EXPERIENCE AND QUALIFICATIONS:

  • The position requires excellent analytical, oral communication, and writing skills.
  • The ideal candidate will have 10+ years of legal experience, with at least 3-4 years of law firm experience or experience as a government litigator in patent litigation and at least 2-3 years of in-house experience in pharmaceutical and/or biotechnology litigation. 
  • The ideal candidate will also be able to demonstrate a strong track record of success.
  • An advanced degree in the biological sciences (e.g., genetics or immunology), or its equivalent in experience, is strongly preferred.
  • Admission to the New York bar is preferred. Attorneys not admitted in New York will also be considered under the New York’s in-house counsel registration practice.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

104) Clinical Program Manager – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) B94RP

DESCRIPTION:

  • Accountable for successfully overseeing program level execution of all clinical operations deliverables, and leads the clinical program team to meet program goals and objectives.
  • Assists in the planning and execution of clinical projects while adhering to budget, scope and schedule requirements
  • Responsible for the execution of a suite of clinical trials from protocol design to the final clinical study report
  • Creates and maintains clinical program timelines for study start-up, maintenance and close-out
  • Attend clinical meetings and inform members of relevant clinical program updates
  • Ensure study timelines are met, and study progress is tracked and reported
  • Work with the clinical scientist and medical monitor to develop protocols and all documents required to initiate and conduct clinical studies (includes informed consent forms, investigator brochures, case report forms, etc.)
  • Oversee performance of CROs and/and or regional CRAs to ensure compliance to the protocol and regulations, including attending site visits, co-monitoring and review of IMV reports
  • Select and manage vendors required to conduct clinical studies (includes overseeing contracts, payments, and deliverables to ensure quality of service provided)
  • Select study investigators and evaluate adequacy to perform research and meet study timelines
  • Develop, implement, and manage project-level clinical budgets and timelines (includes communicating initial strategies and changes to project team as appropriate)
  • Develop, implement, and manage monitoring plans (may include some site visits to manage site and vendor relationships and to ensure quality of data/services)
  • Oversee study drug supply and ensure the project team is updated on all new developments or changes in supply needs
  • Identify project risks and proactively create and implement mitigation strategies
  • Collaborate effectively with cross-functional management teams and external partners
  • Communicate with management to ensure adequate resources are assigned to achieve program deliverables
  • Mentor CRAs and other operational personnel
  • May manage direct reports (contract, term &/or FTE)
  • Coordinate and participate in investigator meetings

EXPERIENCE AND QUALIFICATIONS:

  • Thorough knowledge of personal computers and MS Office Suite.
  • Knowledge of GCP and ICH guidelines required.
  • Bachelor's degree in a relevant scientific discipline or equivalent.
  • 8+ years of independent clinical trial management experience (including vendor management) as a CRA in the pharmaceutical industry and additionally 0-2 years of experience as a clinical project manager responsible for the implementation of multiple concurrent clinical trials.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

105) Data Entry Operator – Contract (New Jersey) 6760

DESCRIPTION:

  • Review payroll timekeeping input to ensure timely completion and accuracy
  • Compare timekeeping systems with employee pay to ensure compliance with proper processes  
  • Partner with retained payroll team and payroll vendor to resolve issues and identify areas of process improvements

EXPERIENCE AND QUALIFICATIONS:

  • Payroll experience
  • Strong attention to detail
  • Familiarity with hourly timekeeping practices 
  • Ability to interact with all levels of the organization
  • Multitasking capabilities and ability to organize large quantities of information
  • College degree preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

106) Senior Java Software Engineer – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) RF103P

DESCRIPTION:

  • Design and develop high performance components/sub-systems for a highly scalable service oriented NGS software
  • Assist in defining the appropriate data models, transformation technologies, and indexing/search algorithms for large-scale genomics data.
  • Use best practices and architectural rigor during the software design process, providing input on alternative strategies and solutions.
  • Write well-documented, extensible software code that is easy to maintain, and that adheres to generally accepted programming standards and OOP practices.
  • Own the overall quality of your code including unit testing, functional testing and performance.
  • Produce and maintain technical designs and documentation relevant to assigned software development tasks.

EXPERIENCE AND QUALIFICATIONS:

  • Highly proficient in JAVA and strong understanding of multi-threaded programming
  • Excellent grasp of OOP concepts and design patterns
  • Experience analyzing and defining requirements, and translating them into technical specifications and architecture
  • Knowledge of DBMS and database architecture and normalization
  • Expertise in one or more technologies like Lucene, Hadoop, Storm, No-SQL database
  • Knowledge of scalability/performance issues and optimization techniques
  • Experience with Web Services (such as Spring and RESTful)
  • Experience with source control and issue tracking systems as well as debugging tools
  • Strong problem solving, analytical and object-oriented programming skills
  • Excellent verbal and written communication skills, teamwork, and time management abilities
  • 5+ years of developing highly scalable, fault-tolerant, distributed backend services for web applications
  • Preferred Bachelor’s degree or equivalent experience in bioinformatics, or computer science with knowledge of Next Generation Sequencing technologies

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

107) Supply Chain Manager – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) T82BL

DESCRIPTION:

Overview:
Responsible for supporting all clinical supply chain activities. Primary duties will include but the oversight of clinical supply CMOs including packaging, labeling  and distribution of IP (investigational product), preparation of label texts and specifications, review of packaging specifications and distribution instructions, submitting and tracking  drug orders, coordinating with clinical operations staff, reviewing and processing temperature data, coordinating domestic and international shipments, tracking and maintaining inventories according to supply plans and study requirements, and document management.

The incumbent will work on a wide range of diverse to complex problems in which analysis of data and/or situations requires an in-depth evaluation of identifiable factors. This position will exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining solutions. 

Responsibilities:
  • Under minimal supervision, manage and execute against drug supply plans in support of clinical programs
  • Coordinate labeling packaging and shipment of packaged supplies: preparation and review of labels proofs and Specifications, preparation and review of Product Packaging Specifications, and preparation and review of Study Distribution Instructions and return Instructions.
  • Requires project management skills including time line generation, action tracking, meeting facilitation, effective communication skills and good documentation practices. 
  • Develop effective relationships with partners across a wide range of staff levels.
  • Develop effective relationships with internal and external partners in supply chain.
  • Assess issues with regards to study design, supply availability and timeline.
  • Promptly identify and escalate risks to study supply to all key stakeholders and internal management.
  • Represent GTO (Global Technical Operations) Clinical Supply Chain in cross-functional clinical study meetings 
  • Work closely with Clinical Supply Chain management to participate in the building and maintenance of clinical study supply plans:
  • Strategize with study managers and review study protocols to determine appropriate packaging configurations, blinding techniques, and optimal distribution plans.
  • Determine distribution strategies for clinical studies.
  • Participate in planning meetings to ensure that project needs, priorities and timing are understood.

EXPERIENCE AND QUALIFICATIONS:

  • Strong understanding of clinical trial design, execution and impact of IP (investigational product) supply. 
  • Proven experience working either in house or with clinical supply CMOs on the execution of packaging, labeling and distribution of IP. 
  • Strong knowledge and understanding of GMP and/or GCP
  • Experience or familiarity with IXRS and managing the forecasting planning of clinical drug supply needs considered a plus.
  • Self-directed with the proven ability to work autonomously.
  • Must possess the ability and desire for problem solving and decision making in a cross-functional team setting.
  • High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines. 
  • Solid interpersonal and communications skills and the ability to deal effectively with a variety of personnel both internally and outside the company. 
  • Proficient in MS-Office (Excel, Word, PowerPoint, Outlook).  
  • Knowledge of Microsoft Visio and Project considered a plus.
  • Flexible, high level of integrity, action and goal-oriented. Balances process and theory with practical application and good judgment. Enjoys a fast-paced, team-oriented, and collaborative environment.
  • Bachelor of Science in life sciences is preferred. Work experience may be substituted for education. 
  • Minimum 4 years in life science industry related experience including Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trails Coordination.
  • At least 2 years direct experience in clinical supplies environment
  • Experience in clinical trial supplies required

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

108) Senior Clinical Research Associate – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) F128KZ

DESCRIPTION:

Overview: 
Ensure timely conduct of clinical studies according to protocols, Good Clinical Practice, Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials. Position reports to Associate Director, Clinical Operations.

Responsibilities:
  • In conjunction with Associate Director, coordinate activities of clinical trial sites.
  • Attend Site Qualification Visits to assess investigator’s staff and facilities.
  • Contribute to study design and initiate planning for global programs (Protocol Amendments and ICF template revisions; Case Report form design and review; Patient instruction cards, and other study materials).
  • Assist in the preparation and review of supportive study documents and study plans (Monitoring Plan, Lab Manuals, Project Plans, IWRS, CRF Guidelines).
  • Ensure all local regulatory approvals are in place for conduct of trial.
  • Conduct study initiation visits, including training of on-site personnel in all aspects of study requirements.
  • Conduct monitoring visits to the sites at intervals specified in monitoring plan.
  • Assist in auditing of clinical trial data for accuracy and consistency and arrange correction of errors as appropriate.
  • Identify, assess and implement appropriate activities to ensure trial progress.
  • Coordinate supplies for specimen collection and shipment of samples for assays.
  • Monitor supply of investigational and comparator drug supply throughout the trial.
  • Assist with product accountability at site and take appropriate action to resolve discrepancies.
  • Report adverse events per protocol and Standard Operating Procedures.
  • Conduct study close-out visits.
  • Document all trial information with adherence to applicable guidelines and Standard Operating Procedures.
  • Remain current with study data.
  • Maintain high level of familiarity with clinical literature of study area.

EXPERIENCE AND QUALIFICATIONS:

  • Preferred knowledge of FDA regulatory requirements and medical practice/techniques and terminology.
  • Ability to work within a team.
  • Excellent communication and interpersonal skills.
  • Attention to detail and highly organized.
  • 25% travel.
  • BA/BS in Life Science or related discipline.
  • 2-5 years of experience in clinical study coordination.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

109) Specialist, Quality Assurance – 6-12 Month Contract (San Francisco Bay Area) G94LT

DESCRIPTION:

SUMMARY:
Works on problems of diverse scope where the analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods, techniques for obtaining solutions.  Normally receives no instructions on routine work and general instructions on new assignments.  Works on assignments that are often highly complex in nature where judgment is required in resolving problems and making routine recommendations.

DUTIES:
  • Perform cGMP/cGLP audits of internal departments and external contractors.
  • Manage, evaluate, and approve Quality System documentation including deviations, CAPA’s, and planned changes.
  • Evaluate document changes for compliance requirements (SOPs, specifications, test methods, etc.).
  • Evaluate compliance of completed manufacturing documents (batch records forms, etc.) and completed QC documents (test results, analytical methods, and bills of testing, etc.) according to Production schedules.
  • Interact with Manufacturing, Fermentation Development, and Quality Control to continually improve compliance with quality systems, internal SOPs, and regulatory requirements and to resolve minor and major deviations.
  • Participate as required in investigatory teams to resolve major quality issues.
  • Participate in compliance audits of quality systems, manufacturing areas, vendor, QC, and support functions as required.
  • Prepare lot release packets in standardized format for upper management review and disposition.
  • Approve areas before use (line and room clearances).

EXPERIENCE AND QUALIFICATIONS:

  • Extensive knowledge of cGMP regulations as they may be applied in clinical biotechnology manufacturing.
  • Previous experience working in a cGLP regulated industry is a plus.
  • Bachelor's degree (B.A. or B.S.) from four-year college or university
  • 6-8 years related experience, 3+ years in Quality Assurance.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

110) Clinical Project Manager – Full Time Position (San Francisco Bay Area) Z82GN

DESCRIPTION:

  • Provide overall coordination and management of a clinical trial, in conjunction with the clinical team, and to serve as the primary contact with the sponsor and clinical team. 
  • Depending on the scope of work, this individual may be involved in some but not all of the functions.
  • Takes a lead role in a study or series of studies, and may provide strategic and tactical planning, organization, direction and tracking for completion of a study or series of studies within a project (including oversight of clinical project timelines, reports, budgets, monitoring, site management, clinical supplies and data collection)
  • Facilitate and foster positive and productive communication between sponsor, team and other functional groups. 
  • Develop and implement a project-specific communication plan, in agreement with the sponsor
  • Ensure timely and accurate communication of all aspects of the project to the team, including sponsor requirements, instructions and changes
  • Communicate with management on project progress, resource needs, sponsor issues, and team member performance
  • With Sponsor input, and based on project requirements, carry out project planning; document plans in writing for distribution to the team, sponsor and management, as appropriate. 
  • Monitor and update plans throughout the life of the project.
  • Quality parameters – identify SOPs, guidelines, templates to be used and provide to members.
  • Develop a plan and obtain sponsor approval before site visits occur;
  • Resource plan – with input from management, and other functional managers, assess how many, who, when and for how long; assess site assignment/workload by region. 
  • Monitor and adjust the resource plan based on project or team member changes
  • Develop contingency plan(s), with team and Sponsor input, for potential hurdles that would delay the project's progress
  • Assess training needs of team members on therapeutic area, protocol, special procedures/skills; develop training plan for new team members added later
  • Develop processes to support the team's activities (i.e. flow of site visit reports and other documents for review and submission, travel calendar, teleconference call-in process, etc.)
  • Identify detailed work activities and develop timelines with team and other functional group input and Sponsor approval (Excel, MSProject tools)
  • Monitor and manage the project's progress, identify hurdles and manage changes, via frequent interactions with team, other functional groups, and sponsor.
  • Schedule regular team meetings/teleconferences to track progress and status of activities and to obtain direction, changes, and decisions
  • Monitor, manage and adjust timelines and milestones with input from team, other functional groups and Sponsor; re-assess critical path and communicate to all
  • Track performance metrics of team
  • Provide informal and formal status reports to Sponsor, team, (and management, as required)
  • Track out-of-scope requests. 
  • Communicate with company and client regarding out-of-scope items
  • Monitor and adjust the resource plan based on project or team member changes
  • Manage study billing/budget versus proposed budget, as appropriate
  • Oversee activities and deliverables of outside vendors, as requested. Ensure communication occurs between outside vendors and others
  • Manage and motivate team members, and monitor and guide their progress.
  • Attend and/or present at Investigator meetings and/or monitor training workshops
  • Develop and/or review study documents (i.e. protocol, investigator brochure, ICF, CRFs, operations manual, study aids, site budget, etc.)
  • Assist members in problem-solving of study and site specific issues
  • Review CRA-generated documents (i.e. site visit reports, letters, telephone reports, as needed)
  • Carry out potential Investigator screening and selection
  • Carry out collection/review of site regulatory documentation

EXPERIENCE AND QUALIFICATIONS:

  • Outstanding interpersonal, oral and written communication skills
  • Proven effectiveness as a team leader
  • Prior experience successfully managing multifaceted studies from inception through implementation and completion.
  • Computer proficiency in Microsoft Word, Excel, and PowerPoint are required. 
  • Experience with MS Project a plus
  • Infectious Disease, phase 3 preferred
  • RN or BS degree in biological sciences or related field or equivalent combination of education and experience: 5+ years CRA experience or 3 years CRA experience and 3 years directly related experience in health care industry.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

111) Manager/Sr. Manager, Clinical Contracts and Outsourcing – Full Time Position (San Francisco Bay Area) RY111J

DESCRIPTION:

  • Partner with legal and finance to write, review, amend, negotiate and close contracts
  • Ensure contracts are fair, equitable and enforceable
  • Keep accurate records, meet report deadlines and document significant events
  • Build and develop strong relationships with vendors
  • Prepare RFP, RFI and contract templates
  • Develop and maintain vendor selection documentation and processes
  • Review contract obligations in conjunction with Project management and Clinical Operations staff
  • Notify vendors/partners/subcontractors formally where issues/special circumstances or breaches of contract have taken place
  • Assist and work with senior management on special projects
  • Monitor vendor progress and performance to ensure goods and services
  • Conform to the contract requirements
  • Authorize payments consistent with the contract terms
  • Resolve disputes in a timely manner
  • Prepare and conduct project kick-off meetings, including delivering detailed briefing to the project and accounting teams

EXPERIENCE AND QUALIFICATIONS:

  • Expertise in large, multi-site, clinical trials with multiple vendor types is required.
  • Experience working departments that have established processes in place.
  • Direct experience vetting and negotiating with vendors is a must.
  • Good understanding of the clinical process is important.
  • Budgeting experience
  • Demonstrated capability of managing multiple external vendors for multiple clinical trials simultaneously.
  • Demonstrated leadership qualities, and strong influencing skills.
  • Management experience would be a plus.
  • Knowledge of applicable regulatory and ICH guidance regarding clinical research and GCP.
  • Demonstrated ability to multi-task, prioritize, and independently solve problems in a rapidly changing environment.
  • A strategic thinker who can efficiently utilize company resources and expertise to extract optimal vendor performance.
  • A strong person with the interpersonal skills and credibility, both internally and externally, to successfully negotiate contracts
  • An excellent communicator, both written and verbal, with the ability to train and present data, complex protocol designs etc., and influence internal and external colleagues as required.
  • Excellent organizational skills and attention to detail.
  • An innovative, driven and effective person with a “can do” attitude.
  • A goal-oriented person who can plan for the long-term and execute stated objectives.
  • A flexible individual who can operate comfortably in a rapidly changing and sometimes ambiguous environment.
  • Minimum of a BS degree with clinical contracts experience, global experience a plus. 
  • Experience in clinical finance, business development, or clinical operations would also be considered.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

112) Manager/Senior Manager, Clinical Contracts – Full Time Position (San Francisco Bay Area) C111KP

DESCRIPTION:


  • Available to interact with management and internal clients.
  • Will be a member of the legal team, a tight-knit group of highly-motivated individuals in a positive, professional working environment. 
  • Assist attorneys and team members in the intake, drafting, negotiation and post-execution administration of non-disclosure, material transfer, clinical trial, vendor services, and other agreements. 
  • The successful incumbent must be a self-starter and comfortable working in a fast-paced environment with high volume production requirements, and meeting frequent tight deadlines under minimal supervision. 
  • Manage the process and workflow of contracts, assure compliance with existing agreements, and ensure the proper routing of documents for full execution by corporate officers and outside parties and perform other duties as assigned by attorneys and other team members. 
  • A clinical focus is strongly preferred although there will be overflow work in other business areas.
  • Prepare drafts of agreements and negotiations with outside parties
  • Gather and confirm facts necessary to initiate contract formation with Legal team and internal stakeholders
  • Generate initial contract drafts and prepare successive redlines
  • Perform initial review of contracts and comments from outside parties
  • Negotiation with outside parties
  • Prepare/format and finalize contracts for execution
  • Work with  Legal team to administer a document-tracking database, including data entry and the generation of summary reports on agreement status
  • Monitor contracts for compliance with company and department policies
  • Perform other tasks as assigned by legal team members

EXPERIENCE AND QUALIFICATIONS:

  • The ideal candidate would also have significant experience working on international clinical studies.
  • Familiarity with the clinical study process
  • Excellent communication skills, both written and verbal
  • Excellent organizational and analytical skills
  • Demonstrated proficiency with Microsoft Office applications (Word, Outlook, Excel, Access) and experience with contract management and database applications
  • Flexible team-player with ability to balance multiple projects and instructions often with competing deadlines
  • Creative, self-motivated, self-starter with strong organizational, prioritization and interpersonal skills
  • Excellent skills for negotiating complex contracts with outside parties.
  • BA/BS and relevant industry experience
  • Minimum of three years’ experience in the review, negotiation and administration of clinical contracts (biotech preferred)

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

113) Research Associate – Contract (~ 25 hr/wk for 6 mths or longer; San Francisco Bay Area) B999RT

DESCRIPTION:

  • Responsible for research and development in collaboration with others.
  • Normally receives minimal instructions on routine work, and detailed instructions on new assignments.
  • Works on problems of diverse scope w here analysis of data requires evaluation of identifiable factors
  • Exercises judgment within defined practices and policies to select appropriate action for obtaining solutions
  • Is aware of method basic development and limited with good, sound laboratory techniques
  • Effectively communicates questions and issues in meetings
  • Keeps accurate notebook records in accordance with SOP and cGMP requirements
  • Presents work summaries and contributes to the corrections and/or updates of existing written documents
  • Follow s GMP / SOP regulations
  • Informs supervisor and is able to correct simple problems with guidance
  • Maintains accountability for methods, procedures and results
  • Must be able to function in a fast-paced and dynamic environment

EXPERIENCE AND QUALIFICATIONS:

  • Must have experience running HPLC and know Chemstation; Excellent understanding of what chromatograms look like; Good analytical skills
  • Strong communication and technical writing skills
  • Demonstrates effective use of software like Word and Excel
  • Masters or Bachelor’s degree in Chemistry or related field, plus relevant experience one to three (1-3) years working for a pharmaceutical company
  • Background in Analytical Chemistry with applicability to routine testing 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

114) Director / Sr Director Medical Director, Respiratory – Full Time Position (San Francisco Bay Area) Y111AE

DESCRIPTION:

  • Strategic planning of clinical development plans required for evaluating the efficacy and safety of investigational drugs and biologics.  
  • With the assistance of direct reports, management and oversight of Phase 2 trials, leading to Phase 3 trials. 
  • This position reports to the CMO and is a member of the executive staff
  • Supports evaluation of safety data from clinical trials and reports safety findings to regulatory authorities and licensing partners
  • Identifies and maintains liaison with leading investigators in the areas of medicine where products are being developed
  • Reports clinical study findings at professional meetings
  • Identify clinical indications appropriate for investigational drugs

EXPERIENCE AND QUALIFICATIONS:

  • At least 10 years of experience in drug development in the biotechnology or pharmaceutical industry; respiratory experience required.
  • Phase 2 and 3 drug development experience including knowledge of clinical trial design, data interpretation and analysis required
  • Excellent verbal and written communication skills
  • Strong interpersonal skills and ability to work effectively with project teams
  • Management experience
  • Medical Doctor degree, board certified

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

115) Senior Medical Director, Drug Safety – Full Time Position (San Francisco Bay Area) MT114A

DESCRIPTION:

Support development programs and post-marketing safety program. Responsible for providing medical guidance, assessment and oversight of any PV/signal detection and risk management on products.  The individual will contribute to set strategies in monitoring and analysis of cumulative safety information in the context of the benefit-risk profile. He or she should be instrumental to effective drug safety crisis management. Responsible for serving as "right hand" for the VP, DSP by preparing analyses and delivering insights; developing presentations; and facilitating strategic meetings. 
Serve as product safety expert and perform surveillance lead responsibilities, including interpretation and evaluation of aggregate adverse event and product complaint data for signal detection, trend analysis, and issue investigations. Demonstrate comprehensive understanding of the safety profile for assigned compounds.   Provide safety strategic guidance to clinical science on safety monitoring.

Job Responsibilities:
  • Effective in building collaborative working relationships within the safety team, functional groups and departments (i.e., Clinical, Regulatory, Quality, Medical Affairs) and corporate partners. 
  • Support VP of Drug Safety Pharmacovigilance on strategic planning and cross functional team programs and departmental initiatives and goals.
  • Timely identification and management of emerging product risks and timely identification of emerging safety issues.
  • Identify important safety issues and analyze pharmacovigilance data for inclusion in reports. 
  • Guidance to safety scientists and safety physicians for aggregate reporting.   Professional knowledge of clinical medicine is essential to sort medical facts in problem analysis and decision analysis.  Initiate and lead clinical interpretation and evaluation of aggregate adverse event and product complaint data.  Lead safety teams or surveillance initiatives to facilitate product safety issues discussion.  
  • Supervise pharmacovigilance personnel (direct reports, consultants and interns), including mentoring, training, and creating an environment for individual growth through problem solving, decision-making, and self-directed learning.
  • Guides regulatory reporting including individual case safety reports (ICSRs), NDA and IND annual report summary statements, and periodic aggregate reports like Periodic Benefit-Risk Evaluation Reports (PBRERs) and Periodic Safety Update Reports (PSURs) *
  • Plans cumulative safety information analyses from company or external databases
  • Demonstrates good understanding of observational studies used in pharmacoepidemiology and ability to provide a sound critique of such studies.
  • Demonstrates proficiency in verbal and email communication, including Microsoft Excel, Word, and Power Point
  • Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines
  • Able to work independently, establishing work priorities and direction
  • Chairs cross functional safety committee meetings (internal or with partner companies); able to present complex information clearly and drive team to effective discussion and resolution.
  • Ensures timely review of protocols, informed consents and other study related documents for multiple products and therapeutic areas
  • Participates on and may lead various cross-functional teams, involving interaction with staff within and external to safety department, to convey and acquire drug safety information internally and externally
  • Directs highly complex communications and ensures that all customers are fully informed and knowledgeable of project activities and their status
  • May conduct and provide oversight of audits/inspections of systems and procedures to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting regulations, including authoring of responses to findings relevant to functional area
  • May participate in budget planning and management

EXPERIENCE AND QUALIFICATIONS:

  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way. 
  • Leadership in biotech/pharmaceutical organization with direct reports.
  • Must have excellent writing and communication skills
  • Familiarity with common safety databases (e.g. Argus, ArisG) is required
  • Previous experience in scientific /medical writing is desired
  • Product launch experience is desired
  • Ability to read and analyze scientific and medical literature
  • Knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments
  • Working knowledge of MedDRA dictionary
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
  • Epidemiology background is a plus
  • Proficient with Windows:  MS Word, Excel, Power Point and ability to learn new programs as needed
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • Must have excellent organizational and problem solving skills
  • Ability to work under pressure and meeting tight timelines
  • M.D., Pharm.D., or Ph.D.
  • Minimum of 7-10 years experience with pharmacovigilance or clinical drug safety including risk/benefit analysis and safety assessment

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

116) Drug Safety Scientist – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) E114AX

DESCRIPTION:

Assists and supports the ongoing aggregate review and analysis of product safety for both pre and post-marketing data. Tasks include preparation and authoring of aggregate safety data including signaling analysis, DSUR, PSURs (Periodic Safety Update Reports), Annual Safety Reports, and reports to support internal/external data safety monitoring boards. Collate relevant clinical safety information for safety signal review as guided by the director or manager.  The Scientist will also support other applicable Pharmacovigilance Plans, EU Risk Management Plans, product recalls, and other safety surveillance activities. The Scientist will author and assist in signal evaluations and the management of responses to regulatory agencies related to the assigned product and support query of safety data under the guidance of manager / director.
 
Responsibilities:

  • Use medical background and experience to integrate case-related information including medical conditions, lab results and procedures and effectively identify risk factors
  • Develop and conduct, with supervisory guidance, certain aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
  • Extensive medical writing, editing, source document review, and data extraction/verification. 
  • Perform literature search and evaluation
  • Track events of special interest
  • Participate in internal pharmacovigilance committee meetings and joint safety meetings with licensing partners (activities include, but are not limited to, presentation of safety data and taking meeting minutes)
  • Assist in preparation of safety related sections and associated documentation for clinical and regulatory documents (including clinical study protocols, patient informed consent forms, clinical study final reports, IND annual reports, DSUR, PSUR, integrated summaries of safety, RMP and European clinical expert reports)
  • Assist in the creation/revision of department procedures and policies

EXPERIENCE AND QUALIFICATIONS:

  • Strong organizational, teamwork, and interpersonal skills and professionalism required.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
  • Outstanding communication skills (verbal and written).
  • Focus on detail with enthusiasm to constantly seek ways to improve processes and practices.
  • Ability to manage multiple projects in a fast-paced environment.
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • Previous Drug Safety/Pharmacovigilance experience of at least 2 years in a global environment.
  • Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial environment as well as post marketing environment
  • Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
  • Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as needed.
  • Familiarity with common Safety databases (e.g., Arisg, AERS, Argu) necessary.
  • At a minimum, Bachelor’s level degree in life sciences, pharmacy, or nursing. RN, PharmD or PhD strongly preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

117) Associate Director/Director, Epidemiology – Full Time Position (San Francisco Bay Area) AR114F

DESCRIPTION:

Provide support with expertise in epidemiology, disease and drug registry, and risk management to drug safety and pharmacovigilance, medical affairs and clinical science teams that are developing investigational drugs or marketed products.  Duties include design and analysis of observational studies, registries and post-marketing surveillance and identification of opportunities for population-based disease understanding, safety signal detection, pharmacovigilance, and risk management activities. Interact directly with drug development, medical affairs and post-market program teams to provide deliverables, progress the program, and meet regulatory requirements.

Job Responsibilities:
  • Working as the epidemiology expert for epidemiology within DSP, the person in this position leads epidemiology project activities
  • Provides epidemiology expertise and experience for drug development and marketed products
  • Collaborates with development teams on clinical trial design, safety analysis plans, and the evaluation of safety signals
  • Collaborates with Medical Affairs on disease registries initiatives.  Advise on design of study to gather targeted disease state information and to address population based questions
  • Investigates safety issues related to development projects and marketed drugs
  • Evaluates databases of health insurance claims and/or electronic health/medical records for the feasibility of epidemiologic studies and/or safety surveillance in addressing questions related to drug safety, disease prevalence, risk, and drug utilization and improve company’s knowledge on advanced epidemiologic know how and methodologies.
  • Recommends study design solutions and works with internal or external stakeholders to conduct studies to address compound/drug- specific issues.
  • Collaborates with development teams on clinical trial design, safety analysis plans, and the evaluation of safety signals.
  • Contribute to risk management plans (including REMS) and direct responsibility for executing studies defined as plan deliverables (e.g., registries, drug utilization studies, other observational studies, post marketing safety requirements) and evaluating the effectiveness of the plans.
  • Interact with company management, internal and external key opinion leaders, and regulators as appropriate to successfully conduct epidemiology studies, signal detection and data mining, and risk management.
  • Maintain smooth communication and good relationship with the key stakeholders, Medical Affairs, and Regulatory Affairs to fulfill the needs of development program and the regulatory post-authorization requirements/commitments.

EXPERIENCE AND QUALIFICATIONS:

  • Significant and demonstrable working knowledge of pharmacovigilance regulations and guidelines, including US, ICH and EU regulations. 
  • Demonstrates effective leadership and management skills, including ability to lead and manage a multidisciplinary team of physicians and scientists (including line managers) and ability to navigate joint decisions with business partnerships.
  • Strong organizational, management, teamwork, and interpersonal skills and professionalism required.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
  • Able to lead meetings, present orally and interact with external bodies
  • Able to work effectively and influence across cultures and functions
  • Proven problem-solving skills and able to work independently
  • Able to manage multiple projects simultaneously and has excellent time management skills
  • Astute observational and analytical skills with a sense of urgency
  • Creative and innovative thinking
  • Able to contribute to strategic decision-making and high-level thinking
  • MPH, PhD in Epidemiology, or Equivalent
  • At least 7 years experience in the health science-related industry with direct exposure to clinical, regulatory or pharmacovigilance functions, including, 5 years epidemiology/pharmacovigilance experience.  
  • Management or team leadership experience essential.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

118) Systems Engineering Manager – Full Time Position (New York) B126XG

DESCRIPTION:

Summary: 
Experience in leading a team of highly skilled systems engineers on complex medical device designs from the conceptual phase through successful product launch. This involves leading the requirements development, systems level architecture design, and interface design definition by collaborating with cross-functional disciplines within the product development environment. His/her team will establish high level product requirements and systems architectures, and will collaborate with department function peers and Project Mangers to create integrated technical designs and project schedules, ensuring that mechanical, electrical, and software subsystems function reliably as one integrated system. Key accountabilities include maintaining the technical competencies of the system engineering team by providing mentoring, training, evaluation, and recruitment.
 
Responsibilities:
  • Facilitate architectural and design decisions to ensure on-time delivery of quality products, within cost, schedule, and performance constraints
  • Lead system engineering processes, in particular establishing design inputs and top down design using various system requirement methodologies
  • Drive hardware and firmware development through the product lifecycle within a stage/phase gate PDP, utilizing risk management techniques and automated requirements traceability tools
  • Ensure team translates market-driven requirements into technical specifications, and ultimately flows them down into lower level hardware and firmware requirement documents
  • Allocate the necessary resources and skill sets to projects ensuring technical, cost, quality, and schedule requirements are met. 
  • Manage resources to meet multiple project needs and objectives. 
  • Gain consensus, lead, influence, and ensure cross-discipline participation and feedback.
  • Work with Project Managers to create and maintain integrated program schedules using advanced scheduling tools and processes such as MS Project, Gantt charts, and WBS
  • Act as technical expert within the system engineering function, advising and coaching subordinates to resolve technical or operational problems
  • Set annual and ongoing goals and objectives for group members. 
  • Write and conduct annual appraisals for group members, actively assessing team’s needs and gaps.
  • Create metrics on tracking design efforts, resources, and effectiveness towards improving product development cycles and quality. Lead functional process and tool improvement initiatives by being early adopter of ideas. 
  • Foster creativity and innovation in design solutions.

EXPERIENCE AND QUALIFICATIONS:

  • Must have experience with digital x-ray equipment technology and imaging science
  • System architecture experience with hardware/software for either medical devices or electro-mechanical devices
  • Experience leading a team in the development of system level product requirements, including high-level system and specific sub-system architectures
  • Successful product lifecycle experience, from the conceptual stage through product launch and into post-launch support.
  • Working knowledge of stage/phase-gate product development process.
  • Able to effectively interface with all project disciplines including Research, Product Development, Service Manufacturing, Regulatory, Marketing, Quality
  • Broad technical experience including electrical, mechanical, and software engineering
  • Experience in the development of processes and procedures which integrate systems engineering and modern design methodologies and associated tools
  • Systematic approach to problem solving and issue resolution combined with good understanding of the relevant technologies and their practical applications
  • Ability to effectively interface with team members in remote locations. 
  • Willing to travel; domestic and international.
  • Develop the skills and abilities of the system engineering function. 
  • Define best-in-class functional processes, standards, and tools. 
  • Conduct ongoing performance benchmarking
  • Strong analytical, problem solving and negotiation skills
  • Self-starter and capable of working with minimal supervision. 
  • Ability to multi-task and provide expertise and leadership across multiple projects.
  • Good oral and written communication skills, especially technical writing
  • Successful product lifecycle experience 
  • Strong technical foundation in engineering design 
  • Strong system architecture, strong system/subsystem integration experience medical devices
  • Strong mix of ME, EE, and SW understanding 
  • Must have X-ray and medical Imaging experience.
  • Strong skills with system/subsystem integration.
  • Strong understanding of HW/SW of electro-mechanical devices.
  • BS or MS degree in Systems, Mechanical, Electrical, Biomedical, or Computer Science. 
  • Strong technical foundation in engineering design principles.
  • Minimum 10 years experience as a Systems Engineer in a regulated industry (i.e. medical, aeronautics, nuclear) developing complex electromechanical systems controlled by embedded/application software
  • Minimum 5 years functional management experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

119) Sr. Product Manager – Full Time Position (San Francisco Bay Area) P73AG

DESCRIPTION:

Detailed Description

The objective of this position is to develop and manage portfolio of software products and services that provide value added growth for the business segment. This person will develop business cases and own all product management responsibilities for a growing portfolio of software products and services. This person will develop and manage a portfolio of on-market and new software products and services. Will be responsible for development of product definition, positioning, pricing and product lifecycle management. Responsibilities include developing market research, leading product management function in new product development teams, managing inventory, pricing, customer communications, support, and revenue forecasts. This position will manage transitioning of products from standalone desktop software to browser based products along with licensing and commercialization models and will manage maintenance and support plans. This position reports to the Director of IT Solutions Product Management in the Applied Sciences Business Unit.
 
Essential Functions
  • Manage worldwide supply, demand, revenue, margin and pricing for product portfolio; update and present forecasts regularly to management, finance, and manufacturing teams. 
  • Analyze market trends, customer requirements and competitive strategy, and identify opportunities for increasing customer and business value through product differentiation. 
  • Lead new product development process from concept through commercialization, including voice of customer research, definition of customer and product requirements and value proposition, formulating and communicating global launch plans including commercialization strategy, public presentations, competitive analysis, forecasting, positioning and training of internal groups, service, support and sales. 
  • Will lead business aspects of both internally-developed products, as well as those leveraged from external collaborations. 
  • Furthermore, our solutions should represent the best thinking of the pioneers of adjacent industries.
  • Will be a strong leader within cross-functional teams developing the right product to fill market needs, and will serve as the customer advocate interacting w/ functional partners including R&D, Program Management, Manufacturing, Market Development, Finance, Customer Services, Quality and Regulatory Associates. 
  • Will partner closely with the Instrument/Reagent Product Managers and Technical Marketing Specialists to ensure system synergies and optimal customer experiences. 
  • The software strategy will be developed and executed in concert with the centrally managed CIO office- ensuring best practices from one division are shared across all operating groups.
  • Desired applicants should bring specific experiences in building software development communities, designing software and building scalable architectures as well as SDKs. 
  • Some knowledge of Biological sciences and/or genomics is desirable, but not required. An aptitude and interest in learning science including bioinformatics is important. 
  • Candidate must possess a track record of success in driving business innovation, product development, building/leading cross functional teams and effective executive level communication.

EXPERIENCE AND QUALIFICATIONS:

  • Implement business strategy for software, including software as a product or a service
  • Lead product definition teams, defining critical product requirement documents with prioritized features and corresponding business or financial justification with ROI.
  • Understand, follow and be accountable for business aspects of Product Commercialization Process (PCP) for products
  • Assess and evaluate competitive landscape
  • Monetize software through direct and indirect economic business models, segregating differentiated value propositions for customer segments
  • Accurate market analysis, value proposition and forecasting and write business cases communicating global launch plans that include regulatory strategy, reimbursement approach, competitive analysis, forecasting, pricing, positioning and training of internal groups.
  • Set pricing to meet revenue and profitability goals
  • Develop customer oriented sales tools and collateral in partnership with manage total product lifecycle, setting organizational cadence for retirement, refresh or enhancement of existing products- in concert with software engineering organization
  • Contribute globally to the company’s office as part of larger stakeholder community
  • Develop a thorough knowledge of target  customer segments, markets and the competition 
  • Contribute to overarching IT solutions strategy and roadmap

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

120) Technical Publications QC Editor – Contract (Southern California) 73K4441

DESCRIPTION:

  • Looking for a technical publications QC editor with an eagle eye for detail, a good sense of humor, and a will-do attitude. 
  • The team supports a large internal client base with needs ranging from emails and brochures to white papers, application notes, and technical sales flyers. 
  • This position will handle overflow technical QC editing for a high volume of these types of pieces under short timelines.

EXPERIENCE AND QUALIFICATIONS:


  • Proficient to thorough understanding of scientific and technical content
  • Exceptional copy-editing and proofreading skills
  • Keen attention to detail, high regard for quality, and excellent written and verbal communication skills
  • Sophisticated knowledge of English usage (grammar, spelling, punctuation, language usage, audience sensitivity)
  • Can effectively adapt structure, tone, and style to meet objectives, as well as apply house style guidelines
  • Ability to develop content that is accurate, clear, concise, and meets the needs of the target audience
  • Ability to work on multiple short- and long-term projects simultaneously in a fast-paced environment and meet deadlines
  • Strong relationship management, project management, and critical thinking skills
  • Generally requires two years of scientific writing experience
  • Requires a bachelor’s degree in the life sciences

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

121) Associate Medical Director, Respiratory – Full Time Position (San Francisco Bay Area) RT111D

DESCRIPTION:

  • Supports the planning and implementation of clinical development plans required for evaluating the efficacy and safety of investigational drugs and biologics.  
  • This position will support the medical monitoring activities and assist Sr. Director, MD, Clinical Development, in the management and oversight of Phase II trials, leading to Phase III trials. 
  • The therapeutic areas of interest include respiratory and oncology.  
  • This position reports to Sr. Director, MD, Clinical Development.
  • Supports medical monitoring efforts in Phase II trials
  • Supports strategic clinical trial input to the clinical operations team
  • Supports investigator selection and evaluations
  • Supports evaluation of safety data from clinical trials and reports safety findings to regulatory authorities and licensing partners
  • Supports writing efforts on clinical study reports
  • Reports status of clinical programs to project teams and management
  • Identifies and maintains liaison with leading investigators in the areas of medicine where products are being developed
  • Reports clinical study findings at professional meetings
  • Assists project teams to identify clinical indications appropriate for investigational drugs

EXPERIENCE AND QUALIFICATIONS:

  • At least two years of experience in drug development in the biotechnology or pharmaceutical industry; respiratory experience desired, but not required.
  • Knowledge of clinical trial design, data interpretation and analysis
  • Ability to analyze, interpret, and report clinical trial findings
  • Effective oral and written communication skills
  • Strong interpersonal skills and ability to work effectively with project teams
  • Medical Doctor degree, board certified

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

122) Manager, Drug Safety Science – Full Time Position (San Francisco Bay Area) F114JX

DESCRIPTION:

  • Identify and assist in the management of safety concerns with drug product(s).  
  • Ensure that any safety signals are appropriately evaluated, communicated and managed with guidance from supervisor.  
  • Responsible for writing documents required for assessment & communication of product safety information for core safety documents.   
  • Perform aggregate safety data tabulation and listing compilation.  Able to provide some clinical judgment on safety data review
  • Collaborate with safety physicians, medical monitors, toxicology group, and other functional groups in identification, analysis, and reporting of possible trends or concerns  
  • Contribute to development & maintenance of product safety profile
  • Track events of special interest and assist in development & maintenance of standardized queries for events of special interest
  • Support  the analysis in support of response to regulatory, EC/IRBs and Investigators or ad hoc inquiries regarding safety issues
  • Draft regulatory inquiry responses
  • Provide input and review to key regulatory or clinical documents (i.e. clinical study reports, investigator brochures, integrated summaries of safety, DSUR); may author certain sections as needed under the supervision of the director
  • Perform literature search and review and able to effective determine appropriate and relevant literature for the purpose of safety analysis.
  • Participate in internal pharmacovigilance committee meetings as well as joint safety meetings with licensing partners

EXPERIENCE AND QUALIFICATIONS:


  • Previous experience in scientific /medical writing required
  • Ability to read and collate scientific and medical literature
  • Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial environments
  • Working knowledge of MedDRA dictionary
  • Familiarity with common safety databases (e.g. Argus, Aris) is preferred
  • Proficient with Windows: MS Word, Excel, PowerPoint and ability to learn new programs as needed
  • Must have excellent writing and communication skills
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • MSc, Pharm.D., Ph.D. preferred
  • Minimum of 3 years experience with pharmacovigilance or clinical safety

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

123) Manager / Senior Manager, Drug Safety – Full Time Position (San Francisco Bay Area) H114FZ

DESCRIPTION:

  • Accountable for the day-to-day management and performance of case management team activities. 
  • Responsible for managing all aspects of safety operations by ensuring the accurate and timely collection, recording, evaluation and reporting of adverse events involving clinical trial and post-marketing studies. 
  • implements department policies and operating procedures. Develops systems, tools and processes for drug safety operations. Reviews and approves adverse event analyses and reports prepared by staff for submission to regulatory agencies. Collaborates with clinical teams, regulatory teams, clinical research organizations and corporate partners in the development of safety reporting procedures and post marketing activities. Sets project goals, timelines and resource requirements.  Maintain efficiency of the case management activities. 
  • Ensure that all Safety reports received from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements (of all relevant countries), alliance agreements, and OPs and procedures.
  • Perform, or provide oversight for, all case processing activities including data entry, narrative writing, quality control, and coding of all cases to ensure accuracy, integrity and completeness of information entered in the Safety database.
  • Oversee the set-up of new Safety projects, including updating Safety Management Plans, and development and set-up of study specific Safety systems and processes (as needed).
  • Manage vendor safety reporting activities including site queries, extraction of eCRF information, and quality assurance.
  • Lead, or participate in, safety data analysis and/or procedure development projects to support the Clinical Drug Safety Science group. Participate in the planning and preparation of the adverse event and/or risk sections of protocols, IBs, and ICFs for  studies and review of CRFs (as necessary).
  • Support the Clinical Operation teams with respect to safety related issues as required.
  • Participate in Clinical meetings representing safety.
  • Oversee reconciliation of Safety database with clinical database for a given study.
  • Provide expert guidance on regulations and their impact on safety management processes and procedures.
  • Participate in the development and management of Data Monitoring Committees, including development of charters and ensure that activities/listings for meetings are completed in a timely manner and meeting outcomes are documented as needed for requests from IRBs/IECs and/or regulatory authorities.
  • Develop, manage, and implement departmental safety policies and SOPs.
  • Manage drug safety staff members, as applicable.
  • Performs other duties as requested.

EXPERIENCE AND QUALIFICATIONS:

  • Previous Safety/Pharmacovigilance experience of at least 5 years in a global environment.
  • Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.
  • Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
  • Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as needed.
  • Familiarity with common safety databases (e.g., Arisg, AERS, Argus, etc.) a must.
  • Strong organizational, management, teamwork, and interpersonal skills and professionalism required.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
  • Outstanding communication skills (verbal and written).
  • Focus on detail with enthusiasm to constantly seek ways to improve processes and practices.
  • Ability to manage multiple projects in a fast-paced environment.
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • Education Requirements (degree, certifications, etc.):
  • At a minimum, Bachelor’s level degree in life sciences, pharmacy, nursing or RN. Master’s Degree or PharmD preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

124) Director, Drug Safety & Pharmacovigilance – Full Time Position (San Francisco Bay Area) GB114A

DESCRIPTION:

  • Responsible for the medical oversight of global pharmacovigilance activities of clinical trials and product development. Post-marketing safety experience is highly desirable.
  • Support Safety Operations to establish and maintain policies and procedures for the Clinical Drug Safety Department. 
  • Perform or provide oversight for the medical review of serious adverse event reports to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.
  • Identify and evaluate safety signals through the assessment of single case safety reports and aggregate trend analyses.
  • Ensure ongoing evaluation of the overall safety profile for investigational products, serving as the product safety expert, working in partnership with medical monitors to bring potential safety issues to the attention of the Clinical Team and upper management
  • Support both Clinical Science and Clinical Operations teams with respect to safety related issues as required
  • Provide input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities. 
  • Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB, and other documents, as needed.
  • Oversee the activities of both internal safety meetings and external safety meetings with licensing partners (i.e. Joint Safety Management Team meetings). 
  • Collaborate with pharmacovigilance and drug safety colleagues from licensing partners to align on a harmonized approach to identifying, evaluating and communicating safety issues.
  • Support development and maintenance of product benefit-risk profile
  • Manage Drug Safety Science staff members, as applicable.

EXPERIENCE AND QUALIFICATIONS:

  • General knowledge of pharmaceutical development and a minimum of 5 - 7 years of experience in Safety/Pharmacovigilance in a global environment.
  • Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.
  • Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
  • Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as needed. 
  • Familiarity with common Safety databases (e.g., Aris, AERS, Argus, etc.) Argus experience preferred.
  • Strong organizational, management, teamwork, and interpersonal skills and professionalism required.
  • Ability to evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
  • Outstanding communication skills (verbal and written).
  • Ability to manage multiple projects in a fast-paced environment.
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • M.D.  required

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

125) Medical Director – Full Time Position (San Francisco Bay Area) B114TN

DESCRIPTION:

Develops the strategies, designs, implements, monitors and evaluates clinical trials and other associated clinical development programs for assigned molecules or drugs. Medical Director will be assigned responsibilities for Ph II and Ph III clinical trials, programs and/or other projects.  Work closely with internal cross-functional stakeholders, external investigators, various corporate partners and regulatory authorities.

  • Plays a lead role in providing clinical input into the assigned therapeutic areas(s) scientific strategy. Helps Research and to ensure consistency of scientific and development strategies with target label claims and corporate goals. May be called upon to perform clinical assessments on relevant drug discovery projects
  • May also consult to Business Development on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic area(s) product pipeline and portfolio
  • Is responsible for creating the clinical development plan for assigned molecules, drugs and/or other programs
  • Regularly called upon to act as an internal consultant to various internal partners, stakeholders, teams and review or decision-making committees; providing clinical development expertise in relation to assigned therapeutic area(s)
  • Develops and delivers key presentations, both internally and externally, to convey the clinical development perspective and provide updates on activities.  Includes playing a key role in the organization and delivery of successful expert advisory boards
  • Participates in FDA or other health authority interactions with little or no supervision from his/her manager
  • Works with Regulatory and other partners/stakeholders in the completion and submission of IND (investigational new drug) applications and filings.  Supports Regulatory Affairs on clinical development aspects of filings; plays a central role in developing language in a drug’s Package Insert.  Acts as the clinical lead on Filing Teams.  Monitors IND filings for all assigned molecules and programs
  • Provides clinical oversight for a variety of projects:
  • Works with a host of internal and external partners and stakeholders in the design and implementation of clinical trials for assigned molecules and drugs
  • Designs and develops trial protocols; including effectively incorporating cross-functional strategies and input into programs
  • Develops the product safety profile
  • Gains alignment with various internal partners and stakeholders on goals and resource needs.  Includes working with core team project teams to establish appropriate budgets and other resource plans
  • Develops key clinical sections of Investigator brochures
  • Plays a key role in the identification of appropriate external investigators
  • Produces clinical components of presentations at clinical trial investigator meetings; delivering high-quality presentations at such meetings
  • Converts clinical development plans into project implementation plans and leads clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators, Clinical Operations and others internally and externally.  Measures project progress, monitors variances and is expected to proactively identify any issues or challenges and develop, recommend and implement strategies to effectively resolve such
  • Plays an important role in the development of disease and/or treatment registries.  Includes developing strategies or plans to enable appropriate registry recruitment
  • Keeps all partners abreast of developments throughout all applicable intervals
  • Contributes to safety and/or other relevant sections of IND annual reports, as these sections and reports relate to assigned molecules and/or drugs
  • May interact with Board of Directors and Investor Relations
  • Works closely with Clinical Operations to  close-out clinical trials and complete internal reporting of  trial status and results; including associated publications


EXPERIENCE AND QUALIFICATIONS:

  • Boarded in hematology or oncology
  • Biotech/pharmaceutical industry experience preferred OR be a recognized expert in the field
  • Strong background/experience with clinical trials (as typically measured by 2 or more years’ experience)
  • Strong, relevant therapeutic experience (as typically measured by 3 or more years’ relevant clinical experience)
  • In-depth understanding and firsthand knowledge of Phase I-III drug development.  
  • Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
  • Demonstrate ever-increasing competence and abilities in leading disease strategy planning and reviews.  
  • Expected to provide important, strategic inputs in Clinical Development decision-making
  • Create targeted and executable clinical development plans for multiple molecules and or drugs
  • Deliver multiple projects and programs on-time, on-target and within-budget
  • Develop and cultivate important relationships with internal and external partners and stakeholders.  Includes developing and cultivating important relationships with thought leaders and KOLs (key opinion leaders)
  • Competently and collaboratively interact with a host of internal and external partners and stakeholders
  • Effectively represent Clinical Science on multi-disciplinary teams.  
  • Stay informed and abreast of the external landscape as it relates to assigned molecules,  drugs and/or programs and the associated therapeutic area(s)
  • Comprehensive understanding of product and safety profiles
  • Well-versed in medical aspects of FDA regulations 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

126) Professional Discovery Research – Contract (Massachusetts) 2464

DESCRIPTION:

  • Perform in vitro and in vivo assays to contribute towards the discovery and preclinical evaluation of immunotherapeutics and vaccines targeted against diseases   
  • Responsible for performing, documenting and analyzing data generated from experiments designed to characterize immune response elicited to vaccination, characterize antibodies, and study pathogenesis of bacterial targets.
  • Performs ELISA, ELISpot, SDS-PAGE, Western blot, flow cytometry and cell-based assays to evaluate immune response against vaccines and/or characterize antibodies.
  • Use microbiological techniques to evaluate the virulence and pathogenicity of infectious agents.  
  • Maintains and generates bacterial stocks to support preclinical models.
  • Performs in vivo experimental procedures aimed at establishing safety, immunogenicity and efficacy in preclinical models. 
  • Safely handle BSL2 class agents.
  • Document work in lab notebooks and perform laboratory support activities such as maintaining equipment and ordering lab supplies;
  • Summarizes and reports results to the supervisor
  • Perform other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Hands-on experience in performing ELISA, cell-based assays and microbiological techniques is required.
  • Experience handling small laboratory animals is required.
  • Experience handling BSL2 bacterial agents and culturing anaerobic bacteria is preferred.
  • Excellent attention to detail and reliability are essential.
  • Ability to work as a team member, to follow directions effectively and to manage multiple tasks is required. Once trained on the procedures should be able to exercise judgment and be able to plan, execute experiments and analyze obtained results.
  • Experience with Microsoft Excel, Softmax Pro and GraphPad Prism or other statistical analysis software is a plus.
  • B.S. degree in Biochemistry, Immunology, Microbiology, or related field with minimum two years experience in vaccine or biopharmaceutical industry.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

127) SCRA to (Sr) Clinical Trial Manager – Contract or Full Time (San Francisco Bay Area) R82BW

DESCRIPTION:

  • Independently lead clinical trial project execution to ensure that trial timelines, costs, and quality metrics are met for a Phase 1 oncology trial
  • Serves as primary contact for functional area representatives in managing the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments.
  • Oversight for forecasting of clinical supplies
  • Manage study milestones to ensure accurate tracking and reporting of study metrics.
  • Manage trial-specific collaborations with other research entities.
  • Oversee ongoing service provider management (e.g., CROs, IVRS, Central Labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
  • Create and manage clinical trial budgets and staffing/resourcing plans.
  • Provide study-specific direction and mentoring to CRAs, COCs, and support staff as appropriate. 
  • Manage adherence to ICH/GCP/local regulations.
  • Participate in clinical operations initiatives and programs as assigned and other duties as assigned.
  • Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Broad and current knowledge of regulations, clinical development process and therapeutic area to study plans.
  • Proven leadership skills to direct protocol execution to ensure timeline, budget and quality metrics are met.
  • Excellent communication skills to effectively disseminate information within clinical as well as other functional areas as appropriate.
  • Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management.
  • Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
  • Excellent organizational and negotiation skills.  
  • Proven ability in creative problem-solving and possess sound judgment.
  • Team oriented and collaborates effectively with the clinical operations study team, cross-functional team members, and external partners.
  • Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook.
  • Working knowledge of MSProject for development and update of clinical study timelines.
  • Willing to travel – anticipate 25%.
  • Bachelor’s Degree with 8+ years of clinical research experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

128) Sr. QA Associate/QA Manager – Full Time Position (San Francisco Bay Area) G104XB

DESCRIPTION:

Provide consultation in the interpretation of GCP regulations, guidelines, policies, and procedures to staff; plan, conduct, and report independent Good Clinical Practice (GCP) Quality Assurance (QA) audits of internal systems/procedures and vendors against applicable regulations and procedures; support, maintain, review QA systems – Controlled Documentation System, Corporate Training program, and Corrective Action and Preventative Actions (CAPAs); and support/provide management with quality metrics and updates.
 
Responsibilities:
  • Manage the QA Document Control system.
  • Assist in SOP writing and/or review.
  • Assist in preparing and hosting Client audits 
  • Write/review/track CAPAs for audits.
  • Conduct audits (internal systems and vendor) 
  • Provide QA/compliance advice to staff.
  • Perform other related duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Strong knowledge of FDA GCP and ICH regulations, guidelines, and standards governing regulated clinical research is required.
  • Working knowledge and understanding of drug development and global clinical regulatory environment.
  • Outstanding interpersonal, oral and written communication skills.
  • Detail oriented.
  • Available to travel 10% of the time.
  • Bachelor's degree in scientific or related discipline, or equivalent work experience.
  • Minimum of 5-7 years industry experience, with at least 3-5 years in clinical QA.
  • Direct experience with internal/external clinical systems and process audits.
  • Experience in QA audits of Clinical Investigators and Clinical Vendors.
  • Experience in development of SOPs.
  • Strong software and computer skills; including MS Word, Excel, PowerPoint, and Outlook. Excellent presentation skills.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

129) Senior SCRA to Clinical Program Manager Level – Full Time Position (San Francisco Bay Area) W111HL

DESCRIPTION:

  • Reports to Sr. Director Clinical Operations; position initially has no direct reports but may within a year
  • Manage Phase 2A to 2/3 oncology program including CRO’s and vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
  • Works closely and independently with the CMO and Medical Directors and represents clinical operations for this program

EXPERIENCE AND QUALIFICATIONS:


  • Experience in Oncology required
  • Must be hands on and used to a start-up environment
  • Knowledge of GCP and ICH guidelines required
  • Proficiency in the implementation, monitoring, and management of clinical trials
  • Able to work collegially within a team and carry out duties/responsibilities with general instructions
  • Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project
  • Must be willing to travel occasionally (this is an in-house position so very little travel is required)
  • Previous experience as with minimum title of SCRA
  • Study start-up experience is required
  • Global trial experience is desirable
  • Demonstrated stellar track record in the oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities.
  • Bachelor’s degree in a relevant scientific discipline or equivalent
  • At least 4 years of relevant clinical experience in the pharmaceutical industry or equivalent (SCRA) and minimum of 7 years for Clinical Program Manager title. 
  • Must have 3+ years as a CRA in biotech or Pharmaceutical clinical operations (not a device or diagnostics company) environment
  • Basic relocation provided

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

130) Sr. Manager Training – Full Time Position (San Francisco Bay Area) T114GR

DESCRIPTION:

Responsible for monitoring the effectiveness of the training program and maintaining compliance with policies, procedures, and applicable GXP regulations.

Key Accountabilities/Core Job Responsibilities:
  • Manage and develop the training department staff.  Mentor staff for individual growth, process efficiency and effective performance.
  • Interact with department management and training representatives to develop training curricula specific to department needs and ensure that department staff are effectively trained on corporate policies, department processes, GxP procedures, and regulatory requirements.
  • Develop processes and tools for the evaluation of training courses, testing and other processes to ensure the effectiveness of the learning and development activities. 
  • Develop training metrics to optimize the performance of the training system to ensure productivity and effective 
  • Maintain a consultative relationship with department training coordinators and with subject-matter experts to enhance the delivery of training content and to identify opportunities for training program improvement.
  • Manage and maintain the ongoing GXP refresher-training program.  
  • Ensure that GXP employees are provided with current GXP training content on a scheduled basis, schedule GXP training on a defined yearly schedule, and track GXP refresher training completion.
  • Acquire and maintain in depth knowledge of GXP compliance trends in order to develop strategies for the delivery of high quality training courses that are relevant to the needs of the organization.
  • Serve as the subject matter expert for training in support of partner and regulatory agency inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Experience developing and implementing course assessments, testing and other processes to ensure the effectiveness of the learning and development activities.
  • Must have an understanding and application of GXPs in the development, clinical, and commercial area of pharmaceuticals products.
  • Knowledge and understanding of the current pharmaceutical industry and applicable domestic and international regulations.
  • The ability to work with subject matter experts to develop and present diverse training topics.
  • BS/BA degree or equivalent and a minimum of 6 years of related experience
  • Minimum of five years experience leading training initiatives and programs for an organization. 
  • Previous training experience in the biotech or pharmaceutical industry highly desirable.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

131) Manager, Quality Assurance – Full Time Position (San Francisco Bay Area) D114QF

DESCRIPTION:

Establishes and maintains QA programs, systems, policies, processes, procedures and controls as they relate to the manufacture, analytical testing, and material disposition of clinical drug substances and drug products manufactured at CMOs.
 
Key Accountabilities/Core Job Responsibilities:
  • Manages all documents received from CMOs through document change control and archival process, as required by internal procedures
  • Independently reviews and approves master batch records, labels, specifications, and other manufacturing documents of drug substance and drug products under clinical development in compliance with US FDA and international health agency requirements.
  • Independently reviews and approves executed manufacturing batch records, analytical data, and associated documentation, including any deviations and investigation reports related to material disposition.
  • Assists with quality investigations and CAPA recommendations related to manufactured products.
  • Manages the clinical product disposition process to ensure quality review and release of clinical products in accordance with domestic and international regulations.
  • Reviews and approves change control requests to ensure compliance with company procedures, cGMP, and other applicable regulations.
  • Represents QA and provides support to the internal CMC team.
  • Provides and prepares quality metrics as needed.
  • Initiate updates and creation of new SOPs as required.
  • Serves as Quality Representative for regulatory inspections as needed.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent working knowledge and understanding of GMP related requirements, proficiency of regulatory and ICH guidelines. 
  • Broad experience in the pharmaceutical industry with a strong analytical and/or manufacturing background, some R & D a plus.
  • Detail oriented with Quality Assurance background with solid problem solving acumen. 
  • Ability to work effectively in a team environment with great organization skills.
  • Excellent working knowledge of Quality Systems and cGMP standards applicable to clinical trial materials.
  • Ability to analyze and reconcile moderate to complex issues independently.
  • Must be an individual with proven initiative and demonstrated accountability in a fast paced environment.
  • Excellent verbal and written communication and interpersonal skills.
  • Proficient with computers and word processing software (i.e. Microsoft Office products
  • Minimum BA/BS Degree in biological sciences, chemistry, or related field.
  • 9+ years of relative progressive cGMP biotech or pharmaceutical manufacturing environment experience and 6-8 years of operational quality experience executing, developing, and administrating Quality Systems.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

132) Software Quality Engineer – Full Time (Midwest) RG73B

DESCRIPTION:

  • Responsible for ensuring end-to-end quality across a variety of software and data products. Includes functional testing, regression testing, and performance testing it also goes well beyond tests to advocating on behalf of customers, mitigating risks, and promoting best practices  - all while focusing on the big picture and keeping the mission in mind. Immense creativity and a passion for product excellence are expected
  • Define, launch, and enforce best practice processes that promote traceability, reliability, operability, and efficiency in the software delivery process. Mentor and coach a broad mix of technical and non-technical colleagues on these practices. Evangelize verification and validation.
  • Work closely with User Experience, Product Management, and other stakeholders to decipher product requirements, proactively identify product improvements, and push product designs toward quality.
  • Collaborate with engineering teams during product development to document and address quality issues. Review and approve user story cards. Help stakeholders prioritize defects.
  • Lead and execute product testing including development of overall strategies, establishment of performance baselines, capacity forecasting, test automation, tool assessment, and reporting mechanisms.
  • Develop expertise in the company products, software tools, and development processes, using that expertise to identify weaknesses and advocate for quality on behalf of customers.
  • Plan and coordinate release-specific testing efforts with Program/Product management and Scientific QA.

EXPERIENCE AND QUALIFICATIONS:

  • Capable of seeing the forest among the trees, focusing on quality product deliverables, customer satisfaction, and overall testing strategies
  • Strong understanding of testing, tuning exceeding customer expectations of quality.
  • Demonstrated understanding of quality concerns, user-centered design, and software verification and validation techniques.
  • General understanding of the modern software development landscape including cloud computing, architecture stacks, and data storage mechanisms.
  • Acquainted with Selenium, JUnit, and other testing frameworks.
  • Experience leading the evolution from manual testing scripts to automated testing suites.
  • Comfortable working in a fast-paced, dynamic, discovery-oriented environment.
  • Excellent verbal and written communication skills
  • Experience working in an Agile or Scrum environment – preferred, but not required.
  • Experience working in a regulated environment – preferred, but not required.
  • Ability to code in Java (or similar OO language) and SQL as needed for testing – Preferred, but not required.
  • Preferred, not required, background in a scientific, data-oriented domain
  • ISO 9000 training – Preferred, but not required.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

133) Senior Clinical Research Associate – Full Time Position (San Francisco Bay Area) F114NB

DESCRIPTION:

Description

Responsible for implementing set-up, execution, oversight and reporting of clinical studies while ensuring that the conduct of the trial is in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.
 
Key Accountabilities/Core Job Responsibilities:
  • Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements
  • Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents
  • Develop study budget and timelines
  • Prepare regulatory documents and submissions
  • Execute project specific training for internal and external staff
  • Maintain Trial Master File
  • Manage Investigational Product (IP)
  • Manage safety reporting
  • Procure and manage contracts with CROs, study vendors and investigative sites
  • Provide oversight of CROs, independent field monitors and other clinical vendors
  • Review monitoring trip reports and track resolution of all action items
  • Co-monitor at investigative sites to evaluate study site and field monitor performance
  • Collaborate with medical experts, clinical study sites, and clinical study vendors
  • Performs  in-house review of clinical database listings for completeness and accuracy
  • Develops clinical study reports

EXPERIENCE AND QUALIFICATIONS:

  • Excellent verbal and written communication skills
  • Attention to detail
  • Able to organize, manage and set priorities for multiple tasks
  • Strong leadership skills, self-motivated, adaptable to a dynamic environment
  • Able to collaborate effectively with the study team, cross-functional team members, and external partners
  • Knowledge of ICH/GCP and FDA regulations
  • Proficiency in MS Word, Excel and Powerpoint
  • Able and willing to travel approximately 25-30%   
  • 6+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including on-site monitoring experience) 
  • Experience in oncology preferred
  • Experience in global trials preferred
  • Experience with Electronic Data Capture systems preferred 
  • BS/BA degree in a life science, RN, or related field

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

134) Statistical Programmer III – Full Time Position (San Francisco Bay Area) B114NG

DESCRIPTION:

Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Generate Study specific and ad-hoc clinical data listings, summary tables and figures.
 
Key Accountabilities/Core Job Responsibilities:
  • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
  • Create CDISC SDTM and ADaM files and SAS export files to use for Electronic Submission from the data received in non-standard form from various sources.
  • Performs Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Review Data Management Plan, Data validation plan and edit check specifications
  • Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
  • Recognizes inconsistencies and initiates resolution of data problems.
  • Acts as a liaison between statistical programming, subcommittees and project teams as needed. 
  • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
  • Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
  • Acts independently to determine methods and procedures on new assignments.
  • May provide guidance to other lower level personnel.
  • Support lead programmer in generation of analysis datasets, generation of TLFs (Tables, Listings, and Figures), validation of aforementioned data and reports, and maintenance of study documentation
  • Generate and QC summary tables, data listings and figures for in-house analyses of study data or publications using SAS standard coding practices.
  • Validate work of other programmer/analysts at CRO or in-house.
  • Maintain complete and auditable documentation of all programming activities.

EXPERIENCE AND QUALIFICATIONS:

  • Ability to use professional concepts to achieve objectives in creative and effective ways.
  • Experience in the analysis of Oncology clinical trial data a plus.
  • Knowledge of CDISC standard (SDTM & ADaM) a plus.
  • Minimum 5 years Pharmaceutical/Biotech programming experience.
  • NDA submission experience is a plus
  • Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
  • BS in Statistics, Math or Scientific Discipline.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

135) Principal Statistical Analyst/ Senior Manager, Statistical Programming – Full Time Position (San Francisco Bay Area) G114RF

DESCRIPTION:

Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Generate Study specific and ad-hoc clinical data listings, summary tables and figures.
 
Key Accountabilities/Core Job Responsibilities:
  • Project lead level activities.
  • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
  • Create CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
  • Performs Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Review Data Management Plan, Data validation plan and edit check specifications
  • Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
  • Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection. 
  • Recognizes inconsistencies and initiates resolution of data problems.
  • Acts as a liaison between statistical programming, subcommittees and project teams as needed. 
  • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
  • Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
  • Acts independently to determine methods and procedures on new assignments.
  • May provide guidance to other lower level personnel.
  • Works closely with Biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP)
  • Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
  • Create/acquire tools to improve programming efficiency or quality.
  • Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
  • Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.

EXPERIENCE AND QUALIFICATIONS:

  • Ability to use professional concepts to achieve objectives in creative and effective ways.
  • Experience in the analysis of complex Oncology clinical trial data.
  • Experienced in supervising and mentoring programming staff.
  • Solid knowledge of CDISC standard (SDTM & ADaM).
  • Minimum 12 years Pharmaceutical/Biotech programming experience.
  • NDA submission experience and knowledge required.
  • Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
  • BS/MS in Statistics, Math or Scientific Discipline.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

136) Senior Biostatistician – Full Time Position (San Francisco Bay Area) B114MT

DESCRIPTION:

  • Collaboration with clinical scientists on protocol design (author statistical methods section and generate study randomization)
  • Generate statistical analysis plan for assigned protocols (incl. Mock displays)
  • Assume responsibility for individual studies, write statistical portion of integrated clinical/statistical reports
  • Work with SAS programmer to develop statistical programs to perform analysis, prepare data displays, verify data accuracy and validity
  • Supply statistical input for NDA submissions and in response to FDA queries
  • Provide support for investigator publications
  • Review case report forms, data management plan, and monitoring plan to ensure that protocol objectives are met and project standards are maintained

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated sound knowledge of applied statistics and biostatistics and relevant experience in the application of statistics to medical trials. 
  • Experience with SAS. 
  • Strong interpersonal and effective communication skills
  • Pharmaceutical industry experience required. 
  • NDA submission experience required. 
  • Global submission experience is a plus
  • Education Requirements (degree, certifications, etc.):
  • Ph.D. in Biostatistics or closely related discipline with a minimum of 8 years experience in pharmaceutical and biotech industry.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

137) Corporate Paralegal – Full Time Position (San Francisco Bay Area) T111KX

DESCRIPTION:

  • The ideal candidate will have significant experience working on one or more initial public offerings.
  • Prepare board of director and stockholder resolutions, and corporate filings
  • Prepare and oversee required corporate filings
  • Assist with board and stockholder matters
  • Assist with corporate secretary responsibilities for foreign subsidiaries
  • Maintain and organize good corporate books and records
  • Work with multiple departments including finance and tax
  • Participate in the development/review of department forms and procedures
  • Perform other tasks and special projects
  • Assist in preparation and filing of periodic SEC reports (e.g., 10-Qs, 10-Ks, 8-Ks, etc.)
  • Assist with other corporate and securities compliance matters
  • Prepare, process, and manage Section 16 filings for directors and officers
  • Assist with all aspects of corporate transactions including financings and corporate partnering deals.

EXPERIENCE AND QUALIFICATIONS:

  • Paralegal with SEC/IPO experience
  • Excellent organizational and analytical skills
  • Public company experience, including working on public offerings
  • Flexible team-player with excellent interpersonal and communication skills, both written and verbal
  • Demonstrated ability to balance multiple projects, often with competing deadlines
  • Experience leading projects and ensuring on-time and successful completion of tasks
  • Proficiency with Microsoft Office applications, including Excel and Word
  • Project and process management skills
  • Discretion, sound judgment, tact and diplomacy in all communications
  • Strong preference for well-organized, self-assured, self-starters willing to work irregular hours when needed
  • Contracts drafting and negotiation experience is a strong plus
  • Mandarin helpful but not required
  • BA/BS and/or ABA-approved paralegal certificate, or other comparable legal experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

138) Clinical Contracts Administrator / Paralegal – Full Time Position (San Francisco Bay Area) GY111P

DESCRIPTION:

  • Experience working on clinical contracts in the biotech/pharma setting and significant experience working on international clinical studies.
  • Assist attorneys and team members in the intake, drafting, negotiation and post-execution administration of non-disclosure, material transfer, clinical trial, vendor services, and other agreements. 
  • Must be a self-starter and comfortable working in a fast-paced environment with high volume production requirements, and meeting frequent tight deadlines under minimal supervision. 
  • Manage the process and workflow of contracts, assure compliance with existing agreements, and ensure the proper routing of documents for full execution by corporate officers and outside parties and perform other duties as assigned by 
  • attorneys and other team members. 
  • Prepare drafts of agreements and negotiations with outside parties
  • Gather and confirm facts necessary to initiate contract formation with  Legal team and internal stakeholders
  • Generate initial contract drafts and prepare successive redlines
  • Perform initial review of contracts and comments from outside parties
  • Negotiation with outside parties
  • Prepare/format and finalize contracts for execution
  • Work with the Legal team to administer a document-tracking database, including data entry and the generation of summary reports on agreement status
  • Monitor contracts for compliance with company and department policies
  • Perform other tasks as assigned by the Legal team members

EXPERIENCE AND QUALIFICATIONS:

  • Minimum of three years’ experience in the review, negotiation and administration of clinical contracts (biotech preferred)
  • Familiarity with the clinical study process
  • Intellectual property law background preferred
  • Excellent communication skills, both written and verbal
  • Excellent organizational and analytical skills
  • Demonstrated proficiency with Microsoft Office applications (Word, Outlook, Excel, Access) and experience with contract management and database applications
  • Flexible team-player with ability to balance multiple projects and instructions often with competing deadlines
  • Creative, self-motivated, self-starter with strong organizational, prioritization and interpersonal skills
  • BA/BS and/or ABA-approved paralegal certificate, or other comparable legal experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

139) Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) MT114R

DESCRIPTION:

This position reports to the Clinical Operations department and has overall responsibility for developing, implementing, managing and maintaining Clinical Trial Master File (CTMF) systems according to FDA GCP requirements, ICH GCP requirements and typical pharmaceutical and biotech industry practices.
 
Key Accountabilities/Core Job Responsibilities:

  • Develops and oversees CTMF document control policies, procedures, processes and systems in accordance with all applicable regulatory requirements and established  procedures and policies.
  • Develops document management systems to meet the needs of the Clinical Development department, including paper-based CTMF storage and maintenance systems, as well as electronic CTMF systems (eCTMF).
  • Develops, implements and maintains CTMFs for all clinical trials.
  • Interacts with Clinical Development department staff and relevant cross-functional departments to establish priorities and deadlines for processing and filing of CTMF required documents.
  • Ensures all required CTMF documents are filed, tracked, maintained, and archived in accordance with regulatory requirements and  procedures and processes.
  • Manages and controls the paper-based CTMF storage room and its contents.
  • Manages and controls the eCTMF storage and maintenance systems.
  • Creates systems to ensure that CTMF documents are filed correctly, easily retrievable, and maintained in accordance with all applicable regulatory requirements and  procedures and processes.
  • Develops and manages the archiving systems and retrieval of archived CTMF documents.
  • Functions as the Subject Matter Expert for CTMF document management systems and processes within
  • Provides CTMF support and guidance for internal and external CTMF audits.
  • Provides CTMF support and guidance for US and Ex-US regulatory authority inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent working knowledge of current paper-based CTMF systems and standards and GCPs.
  • Excellent working knowledge of current electronic CTMF systems and standards.
  • Ability to analyze and reconcile complex issues independently.
  • Ability to independently and effectively manage assigned task and projects.
  • Ability to lead and manage CTMF support personnel.
  • Ability to develop or update Standard Operating Procedures and Work Instructions.
  • Excellent verbal and written communication and interpersonal skills.
  • Must be an individual with proven initiative and demonstrated ability in a fast paced environment
  • Established experience and knowledge of general CTMF systems and standards.
  • Established experience and knowledge of paper-based document CTMF systems.
  • Established experience and knowledge of electronic CTMF systems.
  • Established experience providing CTMF support for US and Ex-US regulatory authority inspections
  • Demonstrated knowledge of US and Ex-US regulatory authority CTMF requirements.
  • Proficient in creation of document tracking systems and use of Adobe Acrobat and MS Office Suite.
  • Established experience with design, development and implementation of a paper-based CTMF storage room.
  • Established experience with identification, selection, implementation and maintenance of an electronic CTMF system.
  • Established understanding and experience with Web-based applications for controlled document indexing, tracking and viewing.
  • Must have Bachelor’s Degree or equivalent with a minimum of 8 years of relevant pharmaceutical or biotech CTMF development and management experience, or equivalent experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

140) Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) MT114R

DESCRIPTION:

This position reports to the Clinical Operations department and has overall responsibility for developing, implementing, managing and maintaining Clinical Trial Master File (CTMF) systems according to FDA GCP requirements, ICH GCP requirements and typical pharmaceutical and biotech industry practices.
 
Key Accountabilities/Core Job Responsibilities:
  • Develops and oversees CTMF document control policies, procedures, processes and systems in accordance with all applicable regulatory requirements and established  procedures and policies.
  • Develops document management systems to meet the needs of the Clinical Development department, including paper-based CTMF storage and maintenance systems, as well as electronic CTMF systems (eCTMF).
  • Develops, implements and maintains CTMFs for all clinical trials.
  • Interacts with Clinical Development department staff and relevant cross-functional departments to establish priorities and deadlines for processing and filing of CTMF required documents.
  • Ensures all required CTMF documents are filed, tracked, maintained, and archived in accordance with regulatory requirements and  procedures and processes.
  • Manages and controls the paper-based CTMF storage room and its contents.
  • Manages and controls the eCTMF storage and maintenance systems.
  • Creates systems to ensure that CTMF documents are filed correctly, easily retrievable, and maintained in accordance with all applicable regulatory requirements and  procedures and processes.
  • Develops and manages the archiving systems and retrieval of archived CTMF documents.
  • Functions as the Subject Matter Expert for CTMF document management systems and processes within
  • Provides CTMF support and guidance for internal and external CTMF audits.
  • Provides CTMF support and guidance for US and Ex-US regulatory authority inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent working knowledge of current paper-based CTMF systems and standards and GCPs.
  • Excellent working knowledge of current electronic CTMF systems and standards.
  • Ability to analyze and reconcile complex issues independently.
  • Ability to independently and effectively manage assigned task and projects.
  • Ability to lead and manage CTMF support personnel.
  • Ability to develop or update Standard Operating Procedures and Work Instructions.
  • Excellent verbal and written communication and interpersonal skills.
  • Must be an individual with proven initiative and demonstrated ability in a fast paced environment
  • Established experience and knowledge of general CTMF systems and standards.
  • Established experience and knowledge of paper-based document CTMF systems.
  • Established experience and knowledge of electronic CTMF systems.
  •  Established experience providing CTMF support for US and Ex-US regulatory authority inspections
  • Demonstrated knowledge of US and Ex-US regulatory authority CTMF requirements.
  • Proficient in creation of document tracking systems and use of Adobe Acrobat and MS Office Suite.
  • Established experience with design, development and implementation of a paper-based CTMF storage room.
  • Established experience with identification, selection, implementation and maintenance of an electronic CTMF system.
  • Established understanding and experience with Web-based applications for controlled document indexing, tracking and viewing.
  • Must have Bachelor’s Degree or equivalent with a minimum of 8 years of relevant pharmaceutical or biotech CTMF development and management experience, or equivalent experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

141) Director, Statistical Programming – Full Time Position (San Francisco Bay Area) X111JP

DESCRIPTION:

  • Lead the statistical programming activities for multiple compounds and will lead the programming submission related activities. 
  • Establish standards for programming and efficiency within the group.
  • Manages a team of statistical programmers.
  • Identifies new tools to increase group productivity.
  • Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
  • Provides primary and secondary programming support as needed and harmonizes strategic initiatives (e.g., process improvement) across a therapeutic area or equivalent. 
  • Excellent verbal and written communication skills and interpersonal skills are required.Has understanding of the business beyond the functional area.
  • Capable of recommending new operating procedures as appropriate and determining if the analysis infrastructure needs changes to improve efficiency and minimize errors.
  • Must be able to lead strategic initiatives for the statistical programming group.
  • Represents the statistical programming group at project team meetings.
  • Has the proven ability to directly supervise personnel.

EXPERIENCE AND QUALIFICATIONS:


  • Submission, ISS, and ISE expertise
  • Leadership skills
  • Experience in multiple therapeutic areas is desired
  • Experience in clinical development statistical programming methods and processes in industry setting required
  • Experience in direct management of statistical programmers
  • Experience and in-depth knowledge in CDISC including SDTM, ADaM, Metadata, and controlled terminologies
  • Enable to establish process and develop utilities efficiently for different versions of Implementation Guides and Standards. Enable to assess the impact of procedural or system changes , and develop/implement strategies to maintain consistency of programming
  • Knowledge of SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
  • Good presentation, oral and written communication skills, including a customer base focus, a commitment to quality management, and problem solving experience. 
  • 11 years of experience and a BS degree in Biostatistics/Computer Science or equivalent, or 7 years of experience and a MS degree in Biostatistics/Computer Science or equivalent, or 5 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

142) IVD Systems & Verification Engineer – Full Time Position (San Francisco Bay Area) B118HZ

DESCRIPTION:

  • Work closely with marketing to develop product requirements. 
  • Work closely with other senior technical staff to identify the key technical challenges to meeting said requirements, and develop system architectures for IVD products.  
  • Improve on the process for system and sub-system verification, including test automation and traceability to requirements, specifications and risk. Partake in verification and validation testing as needed. These responsibilities also apply to integration testing. 
  • Perform system level modeling to determine power consumption, throughput/speed, cost, etc.,  for complex IVD products.
  • Perform risk analysis, compliant to relevant international standards, for products in development.  
  • Some lab work with blood based in vitro diagnostics. 
  • Support activities and processes in compliance with applicable international standards and FDA guidelines.

EXPERIENCE AND QUALIFICATIONS:

  • Travel requirements: up to 10%. 
  • Experience with Regulatory requirements for IVD products
  • Experience with SysML and/or UML, Fluidic and electromechanical systems  
  • Experience with MATLAB/Simulink
  • Experience with Code development in one or more of the following: C#, C, Python
  • Experience with DOE, Statistics, and associated tools
  • Good written and oral communication skills are a must.
  • At least eight years overall engineering experience, with at least five years in the medical device or diagnostics industry, or other highly regulated industry (e.g., aerospace, automotive), including one or more successful product launch.
  • Direct experience in test automation, and generally improving the process of verification.
  • Direct experience solving complex system engineering issues, including the interaction of the instrument, assay and consumables, and user.
  • Direct experience working with marketing in the product definition stage, and continuing to the successful verification and validation of a product.
  • BS in Electrical, Mechanical, or Biomedical Engineering. M.S. or Ph.D. is preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

143) Senior QA Specialist, Manager – Contract to Full Time (San Francisco Bay Area) BK106P

DESCRIPTION:

  • Ensure that product and process changes are properly qualified prior to becoming effective. 
  • Review validation activities (IQ/OQ/PQ) including protocols and final reports related to manufacturing processes including inspection equipment and analytical test methods.
  • Establish and manage the design and development process.
  • Manage product risk management file updates, risk assessments to support complaints, CAPAs, and related product risk assessments.
  • Perform training to support compliance to internal procedures and external regulations.
  • Develop and enhance measurement, inspection and test systems for existing products and processes. 
  • Maintain and develop quality assurance inspection and test procedures and work instructions.
  • Coordinate and perform audits of both internal and external operations.  
  • Identify compliance risks and report findings to appropriate management with recommendations for resolution.
  • Design History Record/Batch record review and product release including review of analytical test data.
  • Establish and maintain quality engineering methodologies such as design control, change control, quality planning, complaint handling, auditing, CAPA and supplier management. 
  • Provide quality engineering support/product risk management and technical problem-solving.
  • Review and approval of facility, equipment and manufacturing process/change control documentation.

EXPERIENCE AND QUALIFICATIONS:


  • Strong knowledge of drug cGMP (21 CFR Parts 210, 211 and 820); Knowledge of device or combination product highly desierable
  • Excellent written and verbal communication skills.
  • Experience with analytical and statistical techniques such as DOE.
  • Ability to critically evaluate and troubleshoot complex problems is essential. 
  • Must take initiative and be solution oriented.
  • Must be able to work in a team oriented, fast paced environment with multiple priorities.
  • Minimum 5+ years in drug delivery or combination (drug/device) products.
  • BA/BS Degree in scientific discipline.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

144) Sr. Database Developer (Software Engineering III) – Two Full Time Positions (Midwest) G73RP

DESCRIPTION:

Description:
There are 2 positions, one with more validation and verification. The purpose of the Database Developer is to apply best-practices of engineering disciplines to the management of large amounts of complex data, and to provide oversight and leadership to the Development Team. The emphasis is on data analysis, data integration, systems integration, and system administration but this position will also have some software development.  The technical challenge is natural language processing, big data analysis, requirement identification, prototyping, design and implementation through to customer acceptance. 

Essential Functions:
  • Use prior knowledge and experience to provide functional support and leadership to colleagues
  • Responsible for initial design and development of new database, software and/or extensive revisions.
  • Define technical requirements and create high-level architectural specifications, ensuring feasibility, functionality, and integration with existing systems/platforms
  • Demonstrate expertise in a variety of the field's concepts, practices, and procedures. Rely on extensive experience and judgment to understand complex problems and resolve them efficiently
  • Participate in training and orienting new engineers as they join the team
  • Manage the care and feeding of large and complex data stores serving multiple internal and external consumers
  • Transition R & D reference bioinformatics methods/implementations into operational offerings
  • Integrate third-party database, data transformation, and data visualization systems
  • Design, build, and maintain internal tools to support data curation and ongoing research
  • Maintain existing suite of customer-facing solutions including substantial system and database administration

EXPERIENCE AND QUALIFICATIONS:

  • Skilled in SQL and object-oriented programming (Java preferred, but Ruby, Python, C++, etc. considered) including common data structures
  • Prior exposure to scripting languages (e.g. Perl, Bash), Linux, and web development
  • Data storage and management expertise using a variety of traditional (Oracle, MySQL) and non-traditional “big data” technologies (MongoDB, CouchDB, Cassandra, Neo4j)
  • Experience with data modeling, data integration, data analysis, data mining, database design, and ETL technologies
  • Comfortable with or willing to learn a variety of system administration tasks (command-line interfaces, Linux, yum, CPAN, networking and firewalls, etc.)
  • Values simplicity in software architecture, design, and practices (DTSTTCPW, YAGNI, refactor ruthlessly)
  • Has proven experience with testing and testability
  • Masters and/or Ph.D degree and/or minimum 6 years work experience in related fields.
  • Experience in natural language processing – Preferred, but not required.
  • Experience interacting with semantic web ontologies (OWL, RDF) – Preferred, but not required.
  • Experience working in an Agile or Scrum environment – Preferred, but not required.
  • Experience working in a regulated health sciences related environment – Preferred, but not required.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

145) SCRA / Clinical Trial Manager – Contract or Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JX111Q

DESCRIPTION:

  • Manage Phase 2 global clinical study, CRO’s and Vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
 

EXPERIENCE AND QUALIFICATIONS:

  • Must be hands on and used to a start-up environment
  • Knowledge of GCP and ICH guidelines required
  • Proficiency in the implementation, monitoring, and management of clinical trials
  • Able to work collegially within a team and carry out duties/responsibilities with general instructions
  • Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project
  • Must be willing to travel occasionally (this is an in-house position so very little travel is required)
  • Previous experience as a CPM managing more than one trial in Phase 3 or Phase 2B trial
  • Study start-up experience is highly desirable
  • Global trial experience is highly desirable
  • Demonstrated stellar track record in the oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities.
  • At least 6 years of relevant clinical experience in the pharmaceutical industry or equivalent with 3+ years as a CRA in biotech or Pharmaceutical clinical operations (not a device or diagnostics company) environment, and 1 year prior experience as a CPM preferred
  • 1+ years managing staff/direct reports preferred
  • Bachelor’s degree in a relevant scientific discipline or equivalent

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

146) Senior Director, Healthcare Compliance – Full Time Position (San Francisco Bay Area) BR114F

DESCRIPTION:

Candidate will partner with the leaders of the Commercial, Medical Affairs and Clinical teams, while ensuring that these business units are in compliance with company compliance policies and SOPs.  This role will lead the implementation of corporate compliance programs in multiple departments, and will oversee the design and maintenance of such programs, including but not limited to, maintaining, reviewing and updating Policies and Procedures, developing and conducting training and working in conjunction with the Compliance Operations function to ensure compliance within the company and across business units.  The successful candidate will have exceptional verbal and written communication skills, and be a collaborative, team-player with a demonstrated ability to influence people at all levels of the company to take action.  The candidate will be a strong leader and manager, with experience managing a growing team of professionals at different levels

Job Responsibilities:
  • Support the Chief Compliance Officer in building and operationalizing a robust and effective Corporate Compliance Program for a fast-paced, rapidly growing, company emerging into the Commercial market.
  • Assist the Chief Compliance Officer in the development and implementation of, compliance policy and SOPs, audit/monitoring programs and/or other risk detection and evaluation techniques to monitor compliance.
  • Provide leadership in compliance and further ownership/accountability for compliance & ethics throughout the identified departments within the organization. Effectively and efficiently identify compliance risks, prioritize focus, and implement appropriate Compliance & Ethics controls and management systems as seen with company activities such as sales and marketing, medical affairs, clinical trials, advisory boards, grants, sponsorships and charitable contributions, market access, and other activities.
  • Work cross-functionally with Legal, HR and other stakeholders on planning and implementing company and department specific compliance education programs and content customization. Will require both development and implementation of training programs and management of various 3rd party vendors for training
  • Effectively collaborate with Corporate Compliance teams of third-party business partners and business alliances, while supporting company business in meeting its goals in a compliant fashion
  • Coordinate with Legal, and other stakeholders to conduct reviews of business activities against company’s corporate compliance policies and procedures, and participate in and provide guidance for investigations and internal audits, as deemed necessary.
  • Champion proper resources are integrated with the business to help identify and implement opportunities for improvement in the effectiveness and efficiency of compliance and ethics programs. Implement appropriate metrics to drive desired compliance and ethics focus, behavior and results.

EXPERIENCE AND QUALIFICATIONS:

  • Experience in designing, building and implementing a successful corporate compliance program in a pharmaceutical/biotech company
  • Proven record of accomplishment in the areas of drafting and implementing compliance policies, training, auditing, monitoring and investigations
  • Knowledge of and experience with laws, regulations and industry guidance that affect the pharmaceutical industry including OIG and PhRMA guidelines, healthcare standard operating procedures, federal sunshine act, Foreign Corrupt Practices Act, the UK bribery act, and other anti-bribery laws federal state marketing disclosure laws, and state price reporting statutes,
  • Excellent oral and written communication skills, including presentation capabilities, and the ability to effectively influence employees across departments and throughout the company, including at Senior Management level
  • Exceptional interpersonal skills, and a collaborative team-player, with ability to resolve conflicts at all levels of the organization
  • Experience working with third-party business collaboration partners and in business alliances helpful
  • Ability to recruit and manage a high performing compliance team consisting of professionals at various levels and with various duties
  • Ability to work in a fast-paced, rapidly expanding environment, and to handle multiple complex and confidential tasks, in an organized and efficient fashion to ensure meeting very aggressive project deadlines are met in a timely manner
  • 10-15 years pharmaceutical/biotech company experience,  with 8-10 years of legal, regulatory and/or corporate compliance related experience required
  • Certified Compliance and Ethics Professional (CCEP) certification helpful, but not required
  • Bachelors degree required and Law degree (Juris Doctor) or post-graduate Healthcare related degree strongly preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

147) Clinical Trial Manager / Sr Clinical Trial Manager – Full Time Position (San Francisco Bay Area) RF117Q

DESCRIPTION:

  • Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs
  • Independently oversees and tracks study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects.
  • Initiates and participates in development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study related documents.
  • Oversees and works directly with CROs, vendors, investigators, monitors and other external partners.
  • Leads and participates in internal cross-functional clinical team meetings; serves as main point of contact study-level status updates.
  • Leads and coordinates study start-up activities including feasibility, investigational product and materials preparation, trial master file set-up, CRFs, regulatory documents, and site contracts in conjunction with relevant departments.
  • Supports and coordinates tasks related to data management, participates in database creation and user acceptance testing, input for edit checks and monitoring guidelines, data cleaning activities between study sites, data management and field monitors.
  • Supports CPM in coordination of receipt of all ancillary data e.g. safety lab data, analytic lab data, IVRS randomization data to ensure data is received at the time of database lock.
  • Conducts Trial Master File review and line listing data review

EXPERIENCE AND QUALIFICATIONS:

  • Experience: 7-10+ years clinical research experience in a pharmaceutical/biotech, CRO setting, monitoring experience
  • Phase 3 experience strongly preferred
  • Immunology or Oncology clinical trial experience preferred
  • Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
  • Strong interpersonal, organizational, and multi-tasking skills
  • Able to work independently
  • Excellent attention to detail and problem solving skills
  • Ability to work effectively work in a team setting
  • Travel domestic – up to 25%
  • Science background BS or healthcare degree required, Masters preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

148) Scientist (QC) – Contract (Southern California) 2815V73

DESCRIPTION:

  • Carry out standard operating procedures involving basic laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture products. 
  • Responsible for Batch Data Records, notebooks, customer reports and work order documents. 
  • Utilize specialized technical knowledge and skills to make detailed observations and analyze data to ensure processes and products are within operating parameters. 
  • Advise manager of factors that may affect quality of product. 
  • Suggest options / ideas for corrective and preventative actions. 
  • Complete quality analysis of reagents, components and finished products in accordance with the Manufacturing Schedule. 
  • Maintain equipment, product inventories and related records as assigned. 
  • Note variances on manufacturing documents; audit and evaluate process documents and propose revisions. 
  • Complete, distribute and file records as required in accordance with Document Control Practices. 
  • Actively participate in the identification and implementation of manufacturing procedures intended to optimize existing processes and ensure achievement of regulatory requirements. 
  • Procedures will typically target improvements in assay variability, reduced cycle time, reduced manufacturing time and cost. 
  • Actively participate in troubleshooting and variable identification for specific processes or activities as assigned. 
  • Report findings to team management and members with recommendations for improvement. 
  • May research new methods or steps in a process and present findings and recommendations to the team, including developing new and revised Standard Operating Procedures. 
  • Complete, distribute and file records; prepare ad hoc reports as requested. 
  • May perform other related duties as required and/or assigned. 

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated proficiency in the use of scientific laboratory techniques, equipment and materials required. 
  • Experience in the use of basic laboratory techniques, including buffer preparation, PCR, RT-PCR, quantitative PCR, protein and nucleic acid gel electrophoresis, cloning, nucleic acid isolation/purification, restriction enzyme digests, transformations, flourometry, UV Spec. and Western, Northern and Southern blotting is beneficial. 
  • Experience with analytical methods also a plus: MALDI, CE, HPLC etc. 
  • Experience with radioactive isotopes handling is also desired. 
  • Demonstrated ability to carry out scientific procedures and make recommendations for improvement required. 
  • Experience assessing current processes and techniques and implementing procedural improvements preferred. 
  • Good problem solving skills necessary. 
  • Working knowledge of manufacturing related computer software preferred. Intermediate math skills required.
  • Requires at least two (2) years experience in the application of Molecular Biology laboratory techniques in a manufacturing environment or research laboratory. 
  • Bachelor's Degree in Molecular biology, biochemistry or related life science with at least 5 years of lab experience.
  • Master's Degree in Molecular biology, biochemistry or related life science with at least 2 years of lab experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

149) Clinical Project Manager – Full Time Position - 1-2 days/wk in-house (San Francisco Bay Area) ZG104M

DESCRIPTION:

  • Prepares and revises clinical protocols and informed consent documents
  • Participates in development of case report forms
  • Manages study supplies
  • Recruits and qualifies investigational sites for participation in clinical studies
  • Ensures studies are conducted in compliance with regulatory requirements
  • Oversees monitoring and close-out of study sites
  • May be able to work 20-40% from home, 1-2 days on site

EXPERIENCE AND QUALIFICATIONS:

  • Must be able to work independently while contributing to a team; take initiative
  • Demonstrate excellent verbal and written communication skills
  • Familiarity with medical and pharmaceutical industry terminology and practices
  • Proven effectiveness as a team leader
  • Prior experience successfully managing multifaceted studies from inception through implementation and completion.
  • Computer proficiency in Microsoft Word, Excel, and PowerPoint are required. 
  • Experience with MS Project a plus
  • Ophthalmology or Oncology experience required
  • 4-year degree, preferably in a scientific or health care discipline
  • 4-5 years of prior experience in the Clinical Research Associate role, plus at least two years of CPM experience.
  • 25-40% travel domestic

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

150) Scientist II (Purification) – Contract (Southern California) 73T2809

DESCRIPTION:

  • Carry out standard operating procedures involving basic laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture products. 
  • Responsible for Batch Data Records, notebooks, customer reports and work order documents. 
  • Utilize specialized technical knowledge and skills to make detailed observations and analyze data to ensure processes and products are within operating parameters. 
  • Advise manager of factors that may affect quality of product. 
  • Suggest options / ideas for corrective and preventative actions. 
  • Complete quality analysis of reagents, components and finished products in accordance with the Manufacturing Schedule. 
  • Maintain equipment, product inventories and related records as assigned. 
  • Note variances on manufacturing documents; audit and evaluate process documents and propose revisions. 
  • Complete, distribute and file records as required in accordance with Document Control Practices. Actively participate in the identification and implementation of manufacturing procedures intended to optimize existing processes and ensure achievement of regulatory requirements. 
  • Procedures will typically target improvements in assay variability, reduced cycle time, reduced manufacturing time and cost. 
  • Actively participate in troubleshooting and variable identification for specific processes or activities as assigned. 
  • Report findings to team management and members with recommendations for improvement. 
  • May research new methods or steps in a process and present findings and recommendations to the team, including developing new and revised Standard Operating Procedures. 
  • Complete, distribute and file records; prepare ad hoc reports as requested. 
  • May perform other related duties as required and/or assigned. 

EXPERIENCE AND QUALIFICATIONS:

  • Requires at least two (2) years experience in the application of Molecular Biology laboratory techniques in a manufacturing environment or research laboratory. 
  • Demonstrated proficiency in the use of scientific laboratory techniques, equipment and materials required. 
  • Experience in the use of basic laboratory techniques, including buffer preparation, Protein Purification using column chromatography (AKTA system experience preferred,) TFF, gel electrophoresis and various cell lysis methods.  
  • Experience assessing current processes and techniques and implementing procedural improvements preferred. 
  • Good problem solving skills necessary. 
  • Working knowledge of manufacturing related computer software preferred. 
  • Advanced math skills required.
  • Bachelor's Degree in Molecular biology, biochemistry or related life science with at least 5 years of lab experience.
  • Masters's Degree in Molecular biology, biochemistry or related life science with at least 2 years of lab experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

151) Senior Statistical Programmer – Full Time Position (San Francisco Bay Area) ZA111H

DESCRIPTION:

  • Participate in CRF design, database review, data management plan, data review, data validation procedures, and review of data listings.
  • Design, develop, implement, and maintain software for the monitoring of ongoing studies, reporting, and analysis of clinical trials. 
  • Provide consistency across protocols within a project on CRFs, database design, analysis files, and tables, listings, and graphs.
  • Produce data listings, summary tables and graphics for interim and final analyses and publications.
  • Create statistical files for statistical analysis. 
  • Integrate data across studies within a project. 
  • Test, document, review and validate all programs according to department guidelines.
  • Provide consulting and systems support for applications software. 
  • Develop new applications software and identify key feature set.
  • Coordinate data transfer and/or programming standards with CROs and vendors. 
  • Work with minimal supervision.

EXPERIENCE AND QUALIFICATIONS:

  • Expertise in SAS programming language (especially data step, and summarization procedures), report generation, and standards for programming and validation.
  • Experienced in macro writing. 
  • Knowledge of advanced statistical procedures in SAS including LIFETEST, MIXED, GLM, especially SAS/GRAPH (required). 
  • Experience with CDISC data standards required.
  • Knowledge of database and data warehouse theory. 
  • Data mining experience is a plus.
  • Understanding of regulatory guidelines that affect statistical deliverable.
  • Ability to work on multiple tasks simultaneously and meet project deadlines.
  • Good verbal and written communication skills.
  • MA/MS in a related field with 5 years experience, or BA/BS in computer science, statistics, math with 7 years experience. 
  • Minimum of 7 years of SAS programming and 5 years of clinical trial experience.
  • Mandarin language skills is a plus but not required

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

152) (Sr) Manager Regulatory – Full Time Position (San Francisco Bay Area) KS132P

DESCRIPTION:

  • Actively contributes in the development and implementation of regulatory strategies for product development and approval.  
  • Responsible for specific regulatory document, submission, and compliance issues.  
  • Provide regulatory support to other departments, project teams, and committees in managing the development of company products. Interaction with FDA representatives.
  • Manage the day-to-day regulatory affairs activities for specific projects and related domestic and international applications (INDs, MFs, IMPDs, CTXs, etc.), and prepare for the filing of subsequent licensing applications (NDA, MAA, e-CTD, etc.).
  • Coordinate multiple submissions and projects effectively
  • Execute, independently or with very limited guidance and supervision, product development and regulatory strategies regarding submissions and compliance issues
  • Assess and exercise good, independent judgment in interpretation and implementation of governmental regulations and procedures. 
  • Maintain, organize, prepare and review, clear and effective submissions for existing and new products
  • Manage interdepartmental regulatory matters and provide regulatory guidance to internal personnel (e.g., executive committee; project teams; clinical, preclinical, and manufacturing departments and subcommittees; etc.)
  • Direct interaction with regulatory agencies on defined matters.  Build and maintain excellent relationships with FDA personnel and representatives from corporate partners
  • Foster teamwork and improve intra-/inter-departmental communications
  • Supervise regulatory staff and guide subordinates in carrying out responsibilities.  
  • Coordinate subordinate activities and career development
  • Actively participate in and contribute to various meetings, e.g., project teams, departmental regarding regulatory and product development issues
  • Position will regularly interact with all departments and all levels within a department
  • Position may have direct reports

EXPERIENCE AND QUALIFICATIONS:

  • Thorough working knowledge and understanding (application of knowledge/experience) of FDA regulations
  • Ability to learn and assimilate scientific information
  • Minimally five years regulatory pharmaceutical/biotechnology industry experience
  • Experience and knowledge in the preparation of NDAs and global submissions; Commericial product experience nice to have.
  • Some previous experience in interpretation of FDA regulations, guidelines, policy statements, etc.
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
  • Knowledge of GMPs, GLPs, and GCPs
  • Well organized, detail oriented, effective written and oral communication skills, and good grammatical skills
  • Ability to guide, train, and supervise personnel
  • Computer literate
  • Previous experience in managing interactions with FDA and other regulatory authorities preferred.
  • Previous regulatory/technical management experience preferred
  • B.S. degree in sciences, preferably life science.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

153) Sr. Director, Clinical Quality Assurance – Full Time Position (San Francisco Bay Area) XR96B

DESCRIPTION:

This hands-on position will lead the Clinical Quality Assurance program.  Will develop and improve the existing GCP-related quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures and protocols. Responsible for developing specific internal procedures, training of staff, and hosting FDA inspections.

Job Responsibilities:
  • Develop GCP-related quality system SOPs in compliance with all applicable regulatory requirements.
  • Ensure clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements.
  • Oversee/conduct audits of investigator sites, clinical research organization (CRO) facilities and various clinical vendors.
  • Oversee/conduct audits of clinical study documents, which include investigator brochures, clinical protocols and study reports, case report forms and informed consents forms.
  • Oversee/conduct internal audits to ensure compliance with department guidelines and procedures, and Good Clinical Practice and ICH Guidelines.
  • Provide expert GCP QA advice to Clinical Operations based on analysis and interpretation of updates to GCP regulations to assure best practices.
  • Support the administration of the company’s training program by conducting GCP training to internal departments and externally, if applicable.
  • Manage/conduct targeted training of investigators/site staff.
  • Report GCP deficiencies to QA management.
  • Assist clinical study teams in the development of CAPAs.
  • Coordinate responses to regulatory agency inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Current and strong working knowledge interpretation/implementation of Code of Federal Regulations and ICH Guidelines governing clinical trials and recent initiatives.
  • Excellent verbal and written communication skills, able to lead cross-functional teams and independently, able to prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
  • Position requires a highly diplomatic, tactful and detail oriented individual with exceptional critical reasoning skills.
  • Experience working with clinical sites.
  • Experience in developing SOPs in for quality assurance and compliance.
  • Experience with clinical trials at all phases of development.
  • Experience with creating quality systems in a small company environment.
  • BS/BA degree and minimum 10 years of related experience; or MS/MA degree in related discipline and minimum 7 years of related experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

154) Sr. Director, Clinical Quality Assurance – Full Time Position (San Francisco Bay Area) XR96B

DESCRIPTION:


This hands-on position will lead the Clinical Quality Assurance program.  Will develop and improve the existing GCP-related quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures and protocols. Responsible for developing specific internal procedures, training of staff, and hosting FDA inspections.

Job Responsibilities:
  • Develop GCP-related quality system SOPs in compliance with all applicable regulatory requirements.
  • Ensure clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements.
  • Oversee/conduct audits of investigator sites, clinical research organization (CRO) facilities and various clinical vendors.
  • Oversee/conduct audits of clinical study documents, which include investigator brochures, clinical protocols and study reports, case report forms and informed consents forms.
  • Oversee/conduct internal audits to ensure compliance with department guidelines and procedures, and Good Clinical Practice and ICH Guidelines.
  • Provide expert GCP QA advice to Clinical Operations based on analysis and interpretation of updates to GCP regulations to assure best practices.
  • Support the administration of the company’s training program by conducting GCP training to internal departments and externally, if applicable.
  • Manage/conduct targeted training of investigators/site staff.
  • Report GCP deficiencies to QA management.
  • Assist clinical study teams in the development of CAPAs.
  • Coordinate responses to regulatory agency inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Current and strong working knowledge interpretation/implementation of Code of Federal Regulations and ICH Guidelines governing clinical trials and recent initiatives.
  • Excellent verbal and written communication skills, able to lead cross-functional teams and independently, able to prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
  • Position requires a highly diplomatic, tactful and detail oriented individual with exceptional critical reasoning skills.
  • Experience working with clinical sites.
  • Experience in developing SOPs in for quality assurance and compliance.
  • Experience with clinical trials at all phases of development.
  • Experience with creating quality systems in a small company environment.
  • BS/BA degree and minimum 10 years of related experience; or MS/MA degree in related discipline and minimum 7 years of related experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

155) Consulting Ontologist – Contract (San Francisco Bay Area) FR103P

DESCRIPTION:

  • Assist the ontology group in the development of large, high-quality knowledge base of biological concepts with a particular emphasis on the extension of the system to cover new biological concepts.
  • Focus of this position is on chemistry and drug content.
  • Represent and connect biological and chemical concepts
  • May be involved in quality control of modeled concepts

EXPERIENCE AND QUALIFICATIONS:

  • Detail-oriented
  • Strong logic skills
  • Internet savvy
  • Available for training via phone/web conferences; position is off-site
  • Must maintain minimum level of productivity (currently corresponds to at least 10 hrs/week)
  • Must be legally able to accept consulting work in the US
  • Experience with public sources of information about biochemicals, such as PubChem
  • Experience with public sources of information about drugs, such as Drugs@FDA and ClinicalTrials.gov
  • PhD (or Masters with substantial research experience) in biochemistry or organic chemistry
  • No travel required

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

156) Lead CRA (in-house) – Full Time Position (San Francisco Bay Area) ZW104M

DESCRIPTION:

  • Responsible for tasks that relate to the operations and management of clinical trials. 
  • Monitoring clinical studies of investigational and approved products. This may include qualification, initiation, interim monitoring, and close out site visits.
  • Acting as primary liaison between the study site staff and sponsor company.
  • Monitoring studies by reviewing and reporting to the sponsor on the following: site enrollment and subject status, findings at monitoring visits, protocol deviations/exceptions, serious adverse events and laboratory abnormalities. 
  • Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
  • Reviewing investigational product accountability, including discrepancy resolution.
  • Processing or overseeing transmission of study data to sponsor according to protocol-specified timelines.
  • Reviewing data queries and listings, and working with the study site staff to resolve data discrepancies.
  • Overseeing the study site staff to assess protocol compliance and appropriate data collection including proper handling, storage and shipment of biological samples.
  • Maintaining consistent contact with the study site staff, including investigators, coordinators, client personnel, and other individuals involved in the clinical study.
  • Visit report writing and site correspondence.
  • Training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
  • Managing the preparation, collection and maintenance of trial regulatory documents. 
  • Maintaining complete and accurate study files, and reviewing files to ensure all appropriate documentation is present.
  • Managing, preparing, sending, tracking, and returning investigational supplies at individual sites. 
  • Managing investigational product ordering, packaging, labeling and ongoing inventory.
  • Managing the reporting of serious adverse events. 
  • Developing study-related documents such as: protocols, case report forms, informed consent forms, study binders, standard operating procedures, study guidelines, study management/tracking tools, and monitoring plans.
  • Preparing contracts with investigators/hospitals, and negotiating budgets and payment schedules. 
  • Planning, preparing for, and giving presentations at investigator meetings. 
  • Development and management of study timelines.
  • Assisting with medical writing and regulatory submissions, such as interim, final study, and annual progress reports. Developing or updating Investigational Product Brochures. Preparing documentation for regulatory submissions (IND, NDA, BLA, IDE, PMA).
  • Visit report writing and site correspondence.
  • Interacting with project manager (sponsor or other) through formal and informal communications, including providing updates, identifying issues, sharing of information and instructions.
  • Managing the resource requirements of the project.
  • Supervision and guidance of CRAs, CR Assistants, and external CROs. Conduct of co-monitoring, training and audit visits. Creation of visit report templates. Review of completed visit reports.
  • Managing all aspects of the implementation of a clinical study. 
  • Interdepartmental liaison working with regulatory, data management, bSelection and management of outside vendors, such as CROs, DM groups, investigational product packaging, and central laboratories.

EXPERIENCE AND QUALIFICATIONS:


  • Detail oriented. 
  • Excellent organizational skills, strong interpersonal and communications skills, and strong problem solving skills.
  • Familiarity with medical and pharmaceutical industry, and related terminology and practices. 
  • Extensive knowledge of FDA regulations and their practical implementation.
  • Willingness to travel.
  • Computer proficiency in Microsoft Word, Excel, and PowerPoint
  • Oncology, vaccines or dermatology experience a plus
  • RN or BS degree in biological sciences or related field or equivalent combination of education and experience: 4 or more years successful CRA experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

157) Senior Manager, Bioinformatics – Full Time Position (Midwest) B73FN

DESCRIPTION:

The purpose of this position is to lead a bioinformatics team that focuses on two areas:  (1) develop and maintain the informatics pipelines and algorithms that comprise our knowledge base, and (2) provide project-based bioinformatics support to the Pharma and Clinical Diagnostic Services business to enable the application of cancer knowledge base and bioinformatics methods.
This team mission is to develop and continuously improve methods for identifying the driver aberrations in cancer through the systematic analysis of high-throughput molecular profiling data.

RESPONSIBILITIES

  • Manage a bioinformatics team that provides: Algorithm and method development in support of the continuous growth and improvement of core compendium of genomic data and cancer knowledge. and Project based bioinformatics support to our Pharma Services and Clinical Diagnostics businesses
  • Organizing and leading the Bioinformatics team to ensure a robust and scalable end to end working bioinformatics pipeline and, working with customers and other teams, provide custom bioinformatics analysis and solutions.
  • Provide strategic direction and guidance to Bioinformaticians in their daily analysis and product development efforts as well as their individual career development and growth.
  • Critical assessment of experimental data to identify patterns that improve content usability to answer core questions
  • Guide team in matrixed environment. Ability to allocate development resources to staff projects appropriately in that environment.
  • Provide accurate scoping and estimation of development efforts for projects based on product requirements and a solid grasp of the relevant bioinformatics tools.
  • Investigate, create and develop new methods and technologies for project advancement.
  • Coordination with other R&D functions as well as Product Management and Marketing to identify critical product development features to prioritize for future releases
  • Communication and coordination with leadership to promote effective systems development.
  • Maintain high level of professional expertise through familiarity with current scientific literature, competing technologies and/or products and attendance of scientific seminars and meetings.
  • Communicates the significance of recent scientific and technology developments to peer group.
  • Collaborate with sequencing teams and clinical researchers to qualify product performance.
  • When needed, select external vendors and consultants and manage engagements.
  • Enthusiasm to collaborate with other departments as a technical consultant.
  • Serve as internal technical expert

EXPERIENCE AND QUALIFICATIONS:

  • Expertise in both bioinformatics and genomics applications is required.
  • Proven understanding and experience in the fields of genomics, experimental data processing, high-throughput data analysis, and genomic databases. 
  • Understanding of basic biology and cancer biology a must.
  • Firm grasp of univariate statistical analysis fundamentals necessary. 
  • Experience with multivariate statistics or statistical modeling a plus.
  • Candidates should have knowledge of leading NGS processing techniques for the quantification of gene expression and copy number, and the identification of somatic mutations, gene fusions, and genomic rearrangements.  Direct experience processing NGS data is a plus.  Candidates should be familiar with the limitations of the various NGS platforms and informatic pipelines, so that data are appropriately integrated into analyses.
  • Strong computational skills, particularly in data parsing, cleansing, data modeling, analysis, and database design and implementation.
  • Solid knowledge of unix/linux. Experience with cluster computing a plus.
  • Previous bioinformatics and scientific programming experience necessary; experience with Spotfire, Pipeline Pilot, R, SQL, and NGS a plus.
  • Ability to review, synthesize, and present scientific data and methods.
  • Good written and verbal communication skills.
  • Inspires, motivates and collaborates with others.
  • Anticipates needs and problems while creating solutions.
  • 7 or more years of post-graduate work experience
  • PhD in computer science, computational biology, biostatistics, bioinformatics, or similar (MS acceptable for the candidate with the right experience)

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

158) Clinical Trial Manager – Full Time Position (San Francisco Bay Area) T96NH

DESCRIPTION:

  • Leads activities associated with LOI evaluation and protocol review.  
  • Coordinates the review and communication comments on studies.  
  • In collaboration with the Director, oversees team members, including oversight of vendors.  
  • Coordinates the training of staff involved in programs.  
  • Provides training to Medical Affairs staff and performs performance appraisals of direct reports.
  • Responsible for the review and finalization of project and study-related documents including: protocols, informed consent forms, contracts, budgets, safety reporting, IND Annual updates and review of proposed clinical trial presentations and publications, as required.
  • Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to Director
  • Coordinate and manage Investigational product supply, including overall accountability and reconciliation
  • Responsible for  the preparation of study budgets and timelines
  • Manage project timelines and correlative studies to meet goals
  • Manage contracts, budgets and payment processes for all vendors including clinical trial sites
  • Monitor and track clinical trial progress and provide status update reports
  • Manage vendors
  • Responsible for selection of staff and coordinating training, including documentation
  • Provide guidance on site issues
  • Lead, with minimal supervision, the planning of meetings and presentations, as required
  • Lead the review of clinical data as needed
  • Represent Medical Affairs on the Review Teams
  • Partner with other research and development groups to achieve deliverables
  • Monitoring of sites for adherence to protocol and GCP as required
  • Travel as required to carry out responsibilities
  • Identify and escalate site, vendor and study related issues to director, as appropriate
  • Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner
  • Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals
  • Perform other duties as assigned

EXPERIENCE AND QUALIFICATIONS:

  • Must have demonstrated expertise in relevant clinical trial activities
  • Ability to exercise independent judgment within generally defined practices and policies that lead to processes for achieving results
  • Good organization and planning skills
  • Strong interpersonal skills and communication skills (both written and oral)
  • Ability to problem solve and delegate appropriate tasks to subordinates
  • Knowledge of ICH/GCP guidelines and FDA regulations
  • Strong leadership skills, self-motivated, adaptable to a dynamic environment
  • Able to collaborate effectively with study sites, cross-functional team members, and external partners
  • Proficiency in MS Word, Excel and PowerPoint
  • Able and willing to travel approximately 10-20%  
  • 7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience)
  • Experience in oncology preferred
  • Experience in global trials preferred 
  • BA/BS/MS in a scientific discipline

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

159) Senior Clinical Research Associate / Clinical Trial Manager – Full Time Position (San Francisco Bay Area) MJ96F

DESCRIPTION:

  • Responsible for implementing set-up, execution, oversight and reporting of clinical studies while ensuring that the conduct of the trial is in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.
  • Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements
  • Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents
  • Develop study budget and timelines
  • Prepare regulatory documents and submissions
  • Execute project specific training for internal and external staff
  • Maintain Trial Master File
  • Manage Investigational Product (IP)
  • Manage safety reporting
  • Procure and manage contracts with CROs, study vendors and investigative sites
  • Provide oversight of CROs, independent field monitors and other clinical vendors
  • Review monitoring trip reports and track resolution of all action items
  • Co-monitor at investigative sites to evaluate study site and field monitor performance
  • Collaborate with medical experts, clinical study sites, and clinical study vendors
  • Performs  in-house review of clinical database listings for completeness and accuracy
  • Develops clinical study reports

EXPERIENCE AND QUALIFICATIONS:

  • Excellent verbal and written communication skills
  • Attention to detail
  • Able to organize, manage and set priorities for multiple tasks
  • Strong leadership skills, self-motivated, adaptable to a dynamic environment
  • Able to collaborate effectively with the study team, cross-functional team members, and external partners
  • Knowledge of ICH/GCP and FDA regulations
  • Proficiency in MS Word, Excel and PowerPoint
  • Able and willing to travel approximately 25-30%  
  • 6+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including on-site monitoring experience) 
  • Experience in oncology preferred
  • Experience in global trials preferred
  • Experience with Electronic Data Capture systems preferred 
  • BS/BA degree in a life science, RN, or related field

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

160) Regulatory Consultant – Contract (San Francisco Bay Area) P108DR

DESCRIPTION:

  • Support regulatory affairs activities
  • Support  global clinical trials applications working directly with the CRE

EXPERIENCE AND QUALIFICATIONS:

  • Deep understanding of FDA and rest of world regulations
  • Highly experienced and can work independently; Minimum previous title of Senior Manager Regulatory Affairs in a pharmaceutical or biotechnology company; Higher level preferred
  • On-site work at least part of the time
  • Minimum education at the Bachelors degree level

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

161) Sr. Staff Scientist, Translational Medicine – Full Time (Midwest) M73QL

DESCRIPTION:

  • Provide leadership in the application of cancer data sciences to translational medicine and diagnostics opportunities. 
  • Will be expected to exhibit scientific leadership of cancer genome data sciences.
  • Provide scientific review, and ensure that results intended for internal and external customers are presented clearly and effectively.
  • Strong scientific and technical leadership is expected, along with ability to foster collaboration and innovation from the Translational Medicine team.
  • Partner with bioinformatics colleagues to develop and assess bioinformatics strategies.
  • Contribute to the development of innovative methods, software platforms, and infrastructure.
  • Support and/or lead the development of scientific presentations for scientific conferences and publications.
  • May be required to perform other related duties as required and/or assigned. 

EXPERIENCE AND QUALIFICATIONS:

  • Requires a minimum of  5 years of relevant post-graduate experience in a cancer focused translational medicine related field. Industry experience is a plus.
  • Requires demonstrated expertise and experience working with cancer genomics data, along with a solid understanding of tumor biology and oncogenic signaling pathways.
  • Proven scientific excellence exemplified by lead author publications in high impact trade journals and/or significant contributions to industry programs.
  • Ability to work independently and collaboratively.
  • Requires ability to communicate effectively in spoken and written English language.
  • Prior work experience in industry or tenure-track academic position preferred.
  • Solid understanding of common statistical approaches used with genomic data preferred. 
  • PhD and/or MD in relevant field required.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

162) Staff Scientist, Bioinformatics – Full Time (Midwest) W73BH

DESCRIPTION:

  • Seeking individuals with expertise in bioinformatics and an understanding of the cancer genome to identify cancer driver aberrations and to associate those genetic events with potential therapeutic strategies.  
  • Work collaboratively in a matrix environment to develop data analysis strategies to address key questions about cancer for our internal and external customers.  
  • Applications include diagnostics, target and biomarker discovery, indication selection, and clinical development strategies.
  • Collaborate with Medical Sciences Informatics (MSI) colleagues to understand our customer’s questions about cancer, patients, and drugs, and develop data analysis strategies and plans to answer them.
  • Implement bioinformatics data integration and analysis pipelines in Pipeline Pilot and/or scripting languages, drawing on MSI's large collection of high-throughput genomic data and sample annotations.
  • Develop visualization environments in Spotfire to enable scientists to explore the data and answer questions.
  • Written and verbal presentation of results and methods.
  • May be required to perform other related duties as required and/or assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Proven understanding and experience in the fields of genomics, experimental data processing, high-throughput data analysis, and genomic databases. Understanding of basic biology and cancer biology a must.
  • Firm grasp of univariate statistical analysis fundamentals necessary. Experience with multivariate statistics or statistical modeling a plus.
  • Candidates should have knowledge of leading NGS processing techniques for the quantification of gene expression and copy number, and the identification of somatic mutations, gene fusions, and genomic rearrangements.  Direct experience processing NGS data is a plus.  Candidates should be familiar with the limitations of the various NGS platforms and informatic pipelines, so that data are appropriately integrated into analyses.
  • Strong computational skills, particularly in data parsing, cleansing, data modeling, analysis, and database design and implementation.
  • Solid knowledge of unix/linux. Experience with cluster computing a plus.
  • Previous bioinformatics and scientific programming experience necessary; experience with Spotfire, Pipeline Pilot, R, SQL, and NGS a plus.
  • Ability to review, synthesize, and present scientific data and methods.
  • Good written and verbal communication skills.
  • Inspires, motivates and collaborates with others.
  • Anticipates needs and problems while creating solutions.
  • 5 years of post-graduate work experience
  • PhD in computer science, computational biology, biostatistics, bioinformatics, or similar (MS acceptable for the candidate with the right experience)

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

163) Scientist III, Bioinformatics – Full Time Position (Midwest) P73NA

DESCRIPTION:

  • Collaborate with scientists to understand customer’s questions about cancer, patients, and drugs, and to develop data analysis strategies and plans to answer them.
  • Collaborate with colleagues to understand our customer’s questions about cancer, patients, and drugs, and develop data analysis strategies and plans to answer them. 
  • Implement bioinformatics data integration and analysis pipelines in Pipeline Pilot and/or scripting languages, drawing on large collection of high-throughput genomic data and sample annotations. 
  • Develop visualization environments in Spotfire to enable scientists to explore the data and answer questions. 
  • Written and verbal presentation of results and methods. 
  • May be required to perform other related duties as required and/or assigned. 

EXPERIENCE AND QUALIFICATIONS:

  • Proven understanding and experience in the fields of genomics, experimental data processing, high-throughput data analysis, and genomic databases. 
  • Understanding of basic biology and cancer biology a must.
  • Firm grasp of univariate statistical analysis fundamentals necessary.  
  • Experience with multivariate statistics or statistical modeling a plus.
  • Strong computational skills, particularly in data parsing, cleansing, data modeling, analysis, and database design and implementation. 
  • Solid knowledge of unix/linux.  
  • Experience with cluster computing a plus. 
  • Ability to review, synthesize, and present scientific data and methods. 
  • Outstanding written and verbal communication skills. 
  • Previous bioinformatics and scientific programming experience necessary; experience with Spotfire, Pipeline Pilot, R, SQL, and NGS a plus. 
  • Scientific experience in cancer study and/or research a plus. 
  • Pharmaceutical experience and lead author publications are highly valued. 
  • Inspires, motivates and collaborates with others. 
  • Anticipates needs and problems while creating solutions.
  • Requires a Masters and/or PhD along with minimum 5 years post-graduate work experience in related field

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

164) Associate Director, Clinical Data Management – Full Time Position (San Francisco Bay Area) XT96G

DESCRIPTION:

  • Responsible for the management of the data management group staff and deliverables. 
  • The ideal candidate will build and enforce the appropriate standards in the department for Phase 3 ready. 
  • Responsible for managing CROs and other outside vendors as appropriate. 
  • Act as a liaison between Data Management and Clinical staff.
  • Supervise and provide technical support to the members of the data management department in all activities related to data management.
  • Ensure the data management activities (CRO) adherence to standard and policies that are appropriate and applicable.
  • Direct interaction with functional departments, including Clinical, Regulatory, Safety, and Quality Assurance
  • Ensure data integrity across department following Good Clinical Practices (GCP) and Standard Operating Procedures (SOP)
  • Manage appropriate revision to SOP and policies related to DM and consistent with other department. 
  • Direct supervision all staff in DM department
  • Oversees the work of direct reports to ensure on-time, on-target and within-budget results
  • Provides ongoing coaching, guidance and feedback to ensure direct reports are successful in their work, as well as have the necessary and timely access to information and other resources
  • Conducts regular one-on-one and any other staff meetings to ensure timely communication with direct reports
  • Provides formal performance reviews and career development planning for all direct reports
  • Complies with all company HR policies and procedures, as well as state/federal employment-related laws

EXPERIENCE AND QUALIFICATIONS:

  • Experience working with Oncology trials highly desirable.
  • Phase 3 experience is must, NDA experience is highly desired
  • Strong communication skills, both written and oral
  • 8+ years of Priori management experience in DM
  • Strong computer skills including technical aspects
  • Ability to analyze complex problems/situations requiring in-depth evaluation
  • Ability to use judgment based upon standards and policies to solve problems, meet timelines and provide alternative approaches
  • BS or BA degree in science/computer related field
  • 15+ years clinical data management experience in pharmaceutical/biotech industry, including EDC.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

165) Senior Data Manager – Full Time Position (San Francisco Bay Area) GL85B

DESCRIPTION:

  • Responsible for leading all activities of data management for clinical trials from start up to close out. 
  • Work with internal development colleagues and external clients to ensure delivery to time, quality and cost expectations.
  • Ensure that management’s clinical development objectives are met with regards to Data Management activities
  • Provide operational leadership to the direction, planning, execution, collection and interpretation of all clinical data to the highest quality standards
  • Report status of clinical data management activities to project teams and management
  • Involved in data preparation for reporting clinical study results for regulatory filings, publications, presentations
  • Conduct clinical data management activities using OmniComm’s Trial Master® and Oracle’s Clintrial® Data Management Systems
  • Develop and implement data management standard operating procedures
  • Create written data management plans
  • Design database structures and case report forms consistent with CDISC and CDASH initiatives
  • Manage group of junior data management personnel
  • Work with third-party vendors to develop data transfer specifications
  • Responsible for directing, managing and training CRO/internal staff as appropriate
  • Oversees the data management work and performs day-to-day data management activities. These include resources planning, developing and implementing standard data management procedures, training and supervising junior data management personnel, performing day-to-day data management activities according to ICH guidelines, regulatory requirements and the company’s standard operating procedures. 

EXPERIENCE AND QUALIFICATIONS:


  • Advanced proficiency in core data management activities (e.g., case report form design, data edit specifications and data validation, creation of data management plans, expert use of adverse events and concomitant medication coding dictionaries, attention to detail and data quality)
  • Excellent communication skills and ability to direct others work efforts
  • Strong track record of leading clinical data management activities 
  • Undergraduate or higher degree; at least five years of experience in clinical trial data management in a pharmaceutical, biotech or CRO setting 
  • Bachelors with 5-8 years experience in pharmaceutical / biotech industry

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

166) IT Technical Writer – 6 month contract (San Jose Area) N96GB

DESCRIPTION:

  • Core document areas are ERP implementation, SOX documentation, CRM/Salesforce/Veeva, and General IT controls
  • Types of documents – requirement specifications, design specifications, test strategy, test plans, i.e. IT software development specification documents




      EXPERIENCE AND QUALIFICATIONS:

      • Need deep expertise in the following software:  Word, Excel, Visio, and PowerPoint
      • Previous experience writing and editing IT software development documents
      • Work on site one day a week telecommute is OK.

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      167) ERP Finance / IT Analyst – Contract or Full Time Position (San Francisco Bay Area) GN96Q

      DESCRIPTION:

      • Will serve as the technical lead for the ERP Finance module from implementation through ongoing direct support of the Finance group.
      • Should have completed projects utilizing Microsoft Dynamics AX and preferably AX 2012.
      • Will focus on general business processes (AR, AP, GL) as well as 3PL integration, the Sunshine act and data flows from all other resources which will require integration and reporting. These will include but not be limited to CCM / CRM / SFA.
      • This will be accomplished in a compliant manner. 
      • Responsible for custom reporting, system documentation, requirements gathering, end user training, and system testing (unit and integration).

      EXPERIENCE AND QUALIFICATIONS:


      • Demonstrated ability to successfully and simultaneously manage multiple projects with conflicting objectives
      • Excellent verbal and written communication skills
      • Experience with various FP&A tools
      • Ability to facilitate evaluation and compromise among individuals with different perspectives and needs. Must have initiative and the ability to analyze and recommend solutions.
      • Excellent analytical skills, especially at detailed levels, and the ability to organize data into structured plans.
      • A history of professional progress improvement, especially through certification programs or through educational institutions
      • Background in pharma/biotech a plus
      • Prior experience of configuration in association with excellent business logic to guide away from any customization.
      • Demonstrated ability to provide key metrics; make these metrics available and used throughout the corporation. 
      • Working knowledge of Finance and Accounting functions from an operational perspective including tools, processes (Close, Budget cycles, Headcount planning, etc.), & cross-functional interactions.
      • Willingness and flexibility to accommodate needs of finance team through cyclical processes.
      • Collect, analyze, and document business requirements among Finance, Accounting, and Supply Chain functions, and translate these into necessary SOPs to document ERP processes as directed
      • Experience with supporting commercial aspects of Finance ERP implementation (sales, revenue), as well as non-commercial areas of the business.
      • Inventory management including costing of manufacturing by third party manufacturers
      • May assist in an ERP HR module or integration of a stand-alone HR specific application.
      • At least 3-5 years of ERP implementation experience
      • Bachelors degree in IT, Finance or related

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      168) Sr. Product Manager, Software Solutions – Full Time Position (San Francisco Bay Area) B73XS

      DESCRIPTION:

      Position Objective 

      The objective of this position is to develop and manage portfolio of software products and services that provide value added growth for the business segment. This person will develop business cases and own all product management responsibilities for a growing portfolio of software products and services. Will develop and manage a portfolio of on-market and new software products and services. Will be responsible for development of product definition, positioning, pricing and product lifecycle management. Responsibilities include developing market research, leading product management function in new product development teams, managing inventory, pricing, customer communications, support, and revenue forecasts. This position will manage transitioning of products from standalone desktop software to browser based products along with licensing and commercialization models (SaaS) and will manage maintenance and support plans. This position reports to the Director of IT Solutions Product Management.

      • Manage worldwide supply, demand, revenue, margin and pricing for product portfolio; update and present forecasts regularly to management, finance, and manufacturing teams. 
      • Analyze market trends, customer requirements and competitive strategy, and identify opportunities for increasing customer and business value through product differentiation. 
      • Lead new product development process from concept through commercialization, including voice of customer research, definition of customer and product requirements and value proposition, formulating and communicating global launch plans including commercialization strategy, public presentations, competitive analysis, forecasting, positioning and training of internal groups, service, support and sales. 
      • Lead business aspects of both internally-developed products, as well as those leveraged from external collaborations. .
      • Strong leader within cross-functional teams developing the right product to fill market needs, and will serve as the customer advocate interacting w/ functional partners including R&D, Program Management, Manufacturing, Market Development, Finance, Customer Services, Quality and Regulatory Associates. 
      • Will partner closely with the Instrument/Product Managers and Technical Marketing Specialists to ensure system synergies and optimal customer experiences. 
      • The software strategy will be developed and executed in concert with the centrally managed CIO office- ensuring best practices from one division are shared across all operating groups.
      • Desired applicants should bring specific experiences in building software development communities, designing software and building scalable architectures as well as SDKs. 
      • Some knowledge of biological sciences and/or genomics is desirable, but not required. An aptitude and interest in learning science including bioinformatics is important. 
      • Candidate must possess a track record of success in driving business innovation, product development, building/leading cross functional teams and effective executive level communication.
      • Implement business strategy for software, including software as a product or a service 
      • Lead product definition teams, defining critical product requirement documents with prioritized features and corresponding business or financial justification with ROI.
      • Assess and evaluate competitive landscape – including product offerings.
      • Monetize software through direct and indirect economic business models, segregating differentiated value propositions for customer segments
      • Accurate market analysis, value proposition and forecasting for new products 
      • Write business cases communicating global launch plans that include regulatory strategy, reimbursement approach, competitive analysis, forecasting, pricing, positioning and training of internal groups
      • Set pricing to meet revenue and profitability goals
      • Develop customer oriented sales tools and collateral in partnership with market development
      • Manage total product lifecycle, setting organizational cadence for retirement, refresh or enhancement of existing products- in concert with software engineering organization
      • Contribute globally to the company CIO office as part of larger stakeholder community
      • Develop a thorough knowledge of target customer segments, markets and the competition
      • Contribute to overarching IT solutions strategy and roadmap
      • May be required to perform other related duties as required and/or assigned

      EXPERIENCE AND QUALIFICATIONS:

      • Outstanding written and verbal communication skills are required
      • Track record of success in launching software products and services
      • Demonstrated ability to develop business cases, customer and product requirements for strategic and/or complex products, soliciting and integrating Voice of Customer and User Centered Innovation inputs
      • Demonstrated experience successfully managing product lines, pricing, and forecasting
      • Strong leadership skills within cross functional teams; a demonstrated leader through influence with strong negotiation skills
      • Is customer-centric and keenly aware of markets, trends and competitors
      • Is authentic, transparent and leads by example, holding self and others accountable 
      • Organized with strong project management skills
      • Demonstrates a sense of urgency, contagious optimism and a “can do” attitude
      • Inspires, motivates and collaborates with others; team-first attitude
      • Stretches across borders, breaks silos and builds effective partnerships with customers and colleagues
      • Adept with software development life cycle methodologies and software technologies
      • Experience with validated and regulated markets is a plus
      • 25% travel (domestic and international) is required on periodic basis. 
      • This position is not eligible for relocation benefits.
      • Works in an office environment. 
      • 5-8 years’ experience in software Product Management required
      • Bachelor's degree in software development or information management (MBA strong plus)

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      169) Sr. Product Manager, Software – Full Time Position (San Francisco Bay Area) B73XS

      DESCRIPTION:

      The objective of this position is to develop and manage portfolio of software products and services that provide value added growth for the business segment. This person will develop business cases and own all product management responsibilities for a growing portfolio of software products and services. Will develop and manage a portfolio of on-market and new software products and services. Will be responsible for development of product definition, positioning, pricing and product lifecycle management. Responsibilities include developing market research, leading product management function in new product development teams, managing inventory, pricing, customer communications, support, and revenue forecasts. This position will manage transitioning of products from standalone desktop software to browser based products along with licensing and commercialization models (SaaS) and will manage maintenance and support plans. This position reports to the Director of IT Solutions Product Management.

      • Manage worldwide supply, demand, revenue, margin and pricing for product portfolio; update and present forecasts regularly to management, finance, and manufacturing teams.
      • Analyze market trends, customer requirements and competitive strategy, and identify opportunities for increasing customer and business value through product differentiation.
      • Lead new product development process from concept through commercialization, including voice of customer research, definition of customer and product requirements and value proposition, formulating and communicating global launch plans including commercialization strategy, public presentations, competitive analysis, forecasting, positioning and training of internal groups, service, support and sales.
      • Lead business aspects of both internally-developed products, as well as those leveraged from external collaborations.
      • Strong leader within cross-functional teams developing the right product to fill market needs, and will serve as the customer advocate interacting w/ functional partners including R&D, Program Management, Manufacturing, Market Development, Finance, Customer Services, Quality and Regulatory Associates.
      • Will partner closely with the Instrument/Product Managers and Technical Marketing Specialists to ensure system synergies and optimal customer experiences.
      • The software strategy will be developed and executed in concert with the centrally managed CIO office- ensuring best practices from one division are shared across all operating groups.
      • Desired applicants should bring specific experiences in building software development communities, designing software and building scalable architectures as well as SDKs.
      • Some knowledge of biological sciences and/or genomics is desirable, but not required. An aptitude and interest in learning science including bioinformatics is important.
      • Candidate must possess a track record of success in driving business innovation, product development, building/leading cross functional teams and effective executive level communication.
      • Implement business strategy for software, including software as a product or a service
      • Lead product definition teams, defining critical product requirement documents with prioritized features and corresponding business or financial justification with ROI.
      • Assess and evaluate competitive landscape – including product offerings.
      • Monetize software through direct and indirect economic business models, segregating differentiated value propositions for customer segments
      • Accurate market analysis, value proposition and forecasting for new products
      • Write business cases communicating global launch plans that include regulatory strategy, reimbursement approach, competitive analysis, forecasting, pricing, positioning and training of internal groups
      • Set pricing to meet revenue and profitability goals
      • Develop customer oriented sales tools and collateral in partnership with market development
      • Manage total product lifecycle, setting organizational cadence for retirement, refresh or enhancement of existing products- in concert with software engineering organization
      • Contribute globally to the company CIO office as part of larger stakeholder community
      • Develop a thorough knowledge of target customer segments, markets and the competition
      • Contribute to overarching IT solutions strategy and roadmap
      • May be required to perform other related duties as required and/or assigned

      EXPERIENCE AND QUALIFICATIONS:

      • Outstanding written and verbal communication skills are required
      • Track record of success in launching software products and services
      • Demonstrated ability to develop business cases, customer and product requirements for strategic and/or complex products, soliciting and integrating Voice of Customer and User Centered Innovation inputs
      • Demonstrated experience successfully managing product lines, pricing, and forecasting
      • Experienced with software Product Management from concept through commercialization and all phases in between
      • Experience with Cloud/SaaS based software
      • Experienced with software pricing and/or training in pricing such as from Pragmatic Marketing Certification or other similar
      • Strong leadership skills within cross functional teams; a demonstrated leader through influence with strong negotiation skills
      • Is customer-centric and keenly aware of markets, trends and competitors
      • Is authentic, transparent and leads by example, holding self and others accountable
      • Organized with strong project management skills
      • Demonstrates a sense of urgency, contagious optimism and a “can do” attitude
      • Inspires, motivates and collaborates with others; team-first attitude
      • Stretches across borders, breaks silos and builds effective partnerships with customers and colleagues
      • Adept with software development life cycle methodologies and software technologies
      • Experience with validated and regulated markets is a plus
      • 25% travel (domestic and international) is required on periodic basis.
      • This position is not eligible for relocation benefits.
      • Works in an office environment.
      • 5-8 years’ experience in software Product Management required
      • Bachelor's degree in software development or information management (MBA strong plus)

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      170) General Warehouse Worker – Contract (Pennsylvania) 5225

      DESCRIPTION:

      • Support all warehousing activities including shipping product worldwide
      • Support receiving of Incoming goods
      • Dispensing packaging components to the packaging department
      • Support the annual physical Inventory, 
      • Support the destruction process and any other Inventory management activities.  

      EXPERIENCE AND QUALIFICATIONS:

      • Familiarity with GMP compliance is a plus.
      • Knowledge of Inventory Management software a plus.   
      • Must be detailed oriented, dependable, and able to work independently and also in a team environment.  
      • Looking for a candidate who can pick up tasks quickly and multi-task/prioritize workload in a dynamic, timeline driven, culturally diverse organization.
      • High school diploma or equivalent is required. 
      • Spoken and written English required.

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      171) Clinical Recruiter – Contract or Full Time Position (San Francisco Bay Area) NG104B

      DESCRIPTION:

      • Coordinate with Management Team and Staffing Manager to determine needs 
      • Source and recruit clinical research professionals (Clinical Research Associates, Clinical Project Managers, Clinical Research Assistants and Clinical Line Managers) within the pharmaceutical, biotech, and medical device industry for contract and permanent positions.
      • Identify potential candidates via: internet recruiting, job postings, referrals, pro-active recruiting methods, i.e. cold calling, networking, staff agencies, LinkedIn, maintain database of candidates and professional recruiters
      • Review and respond to incoming and posted resumes
      • Present and sell open jobs to candidates based upon the needs of the position and the candidate's qualifications and preferences
      • Conduct initial phone screens and/or face to face interviews of potential candidates
      • Present qualified candidates to internal managers; coordinate interviews between managers and candidates, and clients, where applicable
      • Conduct/coordinate background screens, skill evaluations, and professional reference checks for all potential new hires
      • Arrange travel for incoming candidates, and submit expense reports for candidate travel
      • Aggressively follow-up with candidates and recruiters (if applicable) throughout the recruitment process from initial interview to final offer and closing
      • Closing responsibilities for all candidates who are extended an offer including securing agreement with the candidate on an entire compensation and benefits package and securing their firm acceptance of the offer.
      • Attend association and industry meetings, job fairs for networking and recruiting
      • Update internal candidate database on regular basis with interview information, client and candidate contacts, new job openings, and placements 
      • Maintain database by calling/e-mailing network minimally every 1-2 months in order to keep contacts active

      EXPERIENCE AND QUALIFICATIONS:


      • Bachelors Degree from an accredited university or college required 2+ years experience as a recruiter in either a permanent or contract capacity
      • Knowledge of and experience in a staffing environment, preferably within a recruitment agency, with an understanding of gross profit margins, markup, and overall profitability to drive recruiting strategy
      • Experience recruiting for clinical research positions and/or knowledge of the clinical industry is required 
      • Ability to self-motivate and develop personal recruiting strategies to meet individual goals
      • Well developed telephone marketing, recruiting and networking skills and the ability to spend 4+ hours per day on the telephone 
      • Exceptional interpersonal, relationship building, presentation and communication skills (verbal & written)
      • Enthusiastic, positive, and persistent approach to business
      • Detail oriented with excellent organizational and time management skills
      • Ability to excel in a fast paced, team environment 
      • Computer proficiency with Outlook, Word & Excel and familiarity with databases

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      172) Diagnostics Product Line Business Owner – Full Time Position (San Francisco Bay Area) RC103X

      DESCRIPTION:

      • Responsible for leading, developing and executing the business, product and go to market (GTM) strategy including business model optimization, new market introduction and ongoing P/L operations for the product line. 
      • Work closely with the extended marketing, product management, sales, software development and executive teams to develop business plans based on in-depth market analysis, define the overall product strategy, and define and implement the product GTM strategy and programs.  
      • Be the key go-to business / product line leader who owns end-to-end business success for the product in the market including P/L.
      • Own the GTM strategy, planning and execution engaging with cross-functional teams to align and manage key capabilities and timelines for successful delivery.
      • Be the go-to person for understanding and guiding product strategy and together with NGS development team drive product roadmap and execution.
      • Conduct market research and develop frameworks for identifying, evaluating and prioritizing business opportunities.
      • Work with business development / channel development to recruit and support new and existing channel partners expanding market reach and penetration.
      • Work with marketing to define, execute and deliver successful marketing programs to generate demand and achieve revenue targets.
      • Be the business and product champion/evangelist externally at events, customer and channel engagements, and the passionate voice of the customer internally.

      EXPERIENCE AND QUALIFICATIONS:

      • Entrepreneur with exceptional value creation instincts and problem solving skills.
      • Deep understanding of the biological diagnostics marketplace with experience successfully launching new molecular diagnostics products.
      • A passionate self-starter with a combination of business, product, and technical knowledge who has a proven ability to kick-start new products and see them through to successful completion
      • Able to evaluate, frame and make compelling recommendations so the executive team can effectively make business strategy and product investment decisions.
      • A strong leader and evangelist who is results driven, detailed, follows through, and has an ability to work effectively at all levels within the organization, customers and partners.
      • Strong analytical skills with experience in data driven decision-making.
      • Comfortable working with scientific, technical, medical and non-technical personnel with exceptional communication skills, including the ability to effectively present to customers.
      • MD or BS in life sciences with MBA or equivalent experience (including relevant advanced studies preferred, ie MS, PhD, bioinformatics certification, etc).
      • Solid business experience with a minimum five years experience in marketing, business, business development and/or channel development.

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      173) Regional Clinical Research Associate – Full Time Position (Texas) N104BX

      DESCRIPTION:

      • Primary responsibility of this position is to provide site management and monitoring of clinical research studies. 
      • Verification of reported study data
      • Investigational product accountability
      • Oversight of compliance and training of site staff on regulatory and protocol-related issues
      • Review of regulatory documents
      • Accurate and timely documentation
      • Reporting and communication
      • Oversight of safety reporting   

      EXPERIENCE AND QUALIFICATIONS:


      • Infectious disease, oncology, dermatology and/or ophthalmology experience a plus.
      • Understanding of regulatory principles and practices
      • Attention to detail
      • Ability to efficiently perform multiple tasks
      • Ability to identify and solve logistical problems
      • Excellent organizational skills
      • Ability to maintain an effective travel schedule
      • Flexibility with changing priorities
      • Effective communication and personal skills necessary for successful teamwork.
      • Travel up to 65% may be required.
      • General computer skills with proficiency in PC-based Microsoft Word and Excel are mandatory. 
      • Qualified candidates must have an RN or 4-year college degree, preferably in a biomedical or science related field, and at least 3 years recent experience as a Clinical Research monitor.  

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      174) Senior Software/Scientific Quality Engineer – Full Time Position (San Francisco Bay Area) MZ103R

      DESCRIPTION:

      • Work with a dynamic and hard-working team to help improve the quality of the flagship systems biology product as well as other scientific analysis products and services.  
      • Work towards improving overall product quality, testing and risk management process.  
      • Work closely with developers, product management, customer service and other groups to proactively seek product information, develop test plans, derive practical use cases, author test cases.
      • Responsible for communicating risks, test status, results to QA, Development, Management.  
      • Perform functional black box testing, white box and test automation. 
      • Scientific testing of biological content through our flagship software
      • Develop test automation scripts with Java based automation tools (such as FitNesse, Selenium, etc)
      • Functional testing including using both GUI and backend tests
      • Involvement with Agile iterative software development process - test-driven development, continuous integration testing, rapid automation to efficiently build best industry software
      • Interpret requirements, specifications to develop test plans, test cases, test documentation
      • As an individual contributor, hands-on involvement in all areas of Quality Assurance including: processes, test plan, test case creation, bug tracking lifecycle, functional testing
      • Think from a customer perspective , creatively solve real user problems
      • Make recommendations for QA process, best practices, other implementation as per business goals
      • Recommend, implement enhancements to automated testing framework 
      • Coordinate/lead efforts for cross functional testing and/or integration tasks

      EXPERIENCE AND QUALIFICATIONS:

      • Strong knowledge of molecular biology and genomics
      • Proficiency with Java or other object-oriented programming languages, automation with WebDriver (Selenium 2), Unix and Windows operating systems, and experience with testing web-based and java-based applications
      • Experience in both white and black box testing and with performance/load testing web apps
      • Familiarity with SQL and database design, and version control software such as CVS or Subversion, and defect-tracking software /processes
      • Experience developing test plans, designing, implementing, executing, analyzing test cases, writing bug reports, assessing risk 
      • Scripting experience with Perl or Python 
      • Experience in test automation using Silk Test, Fitnesse
      • Strong experience with analysis of algorithms, statistical analysis skills and understanding Agile Development Methodologies
      • Experience with multi-tiered web technologies including web servers and application servers
      • Experience with or interest in working with life sciences:
      • Familiarity with the bioinformatics field and with computational biology tools and practices
      • Familiarity with viral and bacterial pathogens, host-pathogen interaction, disease response, infection and inflammation pathways
      • Experience working with data from Next Generation Sequencing (NGS) platforms
      • Familiarity with ontologies, specifically bio-ontologies.
      • Familiarity with general bioinformatics databases and computational biology resources
      • Minimum 3+ years experience in biotech or bioinformatics
      • Preferred 2+ years experience in molecular biology research
      • Preferred 3+ years experience in test automation
      • Minimum M.S. in Molecular Biology (biology, biochemistry, genetics) or equivalent industry experience.
      • Preferred B.S. /M.S. in Computer Science or equivalent industry experience.
      • Preferred PhD in Molecular Biology

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      175) Senior Software/Scientific Quality Engineer – Full Time Position (San Francisco Bay Area) MZ103R

      DESCRIPTION:


      • Work with a dynamic and hard-working team to help improve the quality of the flagship systems biology product as well as other scientific analysis products and services.  
      • Work towards improving overall product quality, testing and risk management process.  
      • Work closely with developers, product management, customer service and other groups to proactively seek product information, develop test plans, derive practical use cases, author test cases.
      • Responsible for communicating risks, test status, results to QA, Development, Management.  
      • Perform functional black box testing, white box and test automation. 
      • Scientific testing of biological content through our flagship software
      • Develop test automation scripts with Java based automation tools (such as FitNesse, Selenium, etc)
      • Functional testing including using both GUI and backend tests
      • Involvement with Agile iterative software development process - test-driven development, continuous integration testing, rapid automation to efficiently build best industry software
      • Interpret requirements, specifications to develop test plans, test cases, test documentation
      • As an individual contributor, hands-on involvement in all areas of Quality Assurance including: processes, test plan, test case creation, bug tracking lifecycle, functional testing
      • Think from a customer perspective , creatively solve real user problems
      • Make recommendations for QA process, best practices, other implementation as per business goals
      • Recommend, implement enhancements to automated testing framework 
      • Coordinate/lead efforts for cross functional testing and/or integration tasks

      EXPERIENCE AND QUALIFICATIONS:


      • Strong knowledge of molecular biology and genomics
      • Proficiency with Java or other object-oriented programming languages, automation with WebDriver (Selenium 2), Unix and Windows operating systems, and experience with testing web-based and java-based applications
      • Experience in both white and black box testing and with performance/load testing web apps
      • Familiarity with SQL and database design, and version control software such as CVS or Subversion, and defect-tracking software /processes
      • Experience developing test plans, designing, implementing, executing, analyzing test cases, writing bug reports, assessing risk 
      • Scripting experience with Perl or Python 
      • Experience in test automation using Silk Test, Fitnesse
      • Strong experience with analysis of algorithms, statistical analysis skills and understanding Agile Development Methodologies
      • Experience with multi-tiered web technologies including web servers and application servers
      • Experience with or interest in working with life sciences:
      • Familiarity with the bioinformatics field and with computational biology tools and practices
      • Familiarity with viral and bacterial pathogens, host-pathogen interaction, disease response, infection and inflammation pathways
      • Experience working with data from Next Generation Sequencing (NGS) platforms
      • Familiarity with ontologies, specifically bio-ontologies.
      • Familiarity with general bioinformatics databases and computational biology resources
      • Minimum 3+ years experience in biotech or bioinformatics
      • Preferred 2+ years experience in molecular biology research
      • Preferred 3+ years experience in test automation
      • Minimum M.S. in Molecular Biology (biology, biochemistry, genetics) or equivalent industry experience.
      • Preferred B.S. /M.S. in Computer Science or equivalent industry experience.
      • Preferred PhD in Molecular Biology

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      176) Clinical Database Programmer – Full Time Position (New York / New Jersey) M100PT

      DESCRIPTION:

      • Accountable for the timely production of clinical database structures, clinical data logic checks, clinical data extraction programs and tools and the conversion of clinical views to extraction datasets for multiple uses.
      • Corresponding Process Diagrams for Electronic Data Capture (EDC) studies)
      • Database programming, including the creation and implementation of eCRF behaviors, validation and derivation procedures and complex data logic checks/programs electronic case report forms (eCRF) (process diagrams for eCRF Design and Set-up and eCRF Updates)
      • Evaluates and manages changes to eCRF / database programming as a result of study change requests or UAT findings.
      • Presents eCRF update options to the SMT.
      • Sets up and manage data extraction (process diagrams for Data Extraction, Final Extraction and Unblinding, Set-up for Data Extraction and EDC file transfer protocol (FTP) Accounts for Data Extracts)
      • Develops, tests and reviews extraction programs, based on user requirements, for reporting and statistical analysis
      • Develops and maintains custom outputs for multiple uses (e.g. medical data review, clinical study reports)
      • Trouble-shoots and contributes to the resolution of data loading and extraction issues
      • Implements software programming standards (e.g. study data tabulation model (SDTM).
      • Communicates effectively with members of the study management team (SMT) to ensure that assigned study-level reporting requirements are clearly communicated and agreed upon
      • Liaises with colleagues for consistent approach to modeling and extraction
      • May participate in SMT and other meetings as needed
      • May be required to give presentations on functional topics

      EXPERIENCE AND QUALIFICATIONS:

      • College/University degree in science or computer-related subject with significant bioinformatics content or two or more years experience in handling biomedical data using programming languages such as PL/SQL, C# or SAS.
      • 5+ to 7 years of experience. 
      • Bachelor's Degree.
      • Willingness to travel occasionally.
      • Demonstrated knowledge of programming Clinical Data Management applications with experience of relational databases most specifically with RAVE.
      • Good written and verbal English communication skills demonstrated by an ability to present clear instruction/direction to individuals and teams.
      • Experience of working as part of or leading a team with a proven ability to make an active contribution to the team's performance. 
      • Ability to communicate clearly with technical and non-technical colleagues.
      • Good presentation skills

       

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      177) (Senior) Clinical Trial Manager – Full Time (San Francisco Bay Area) R96TW

      DESCRIPTION:

      Leads activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines.  Leads study management team, including oversight of CRO and Vendors.  Coordinates the training of staff involved in clinical trial management.  Provides training to clinical operations staff and performs performance appraisals of direct reports.
       

      Key Accountabilities/Core Job Responsibilities:
      • Responsible for  the preparation and finalization of project and study-related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required
      • Responsible for  the selection of investigators and study sites
      • Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor
      • Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT
      • Ensure that CRF data queries are resolved
      • Coordinate and manage Investigational Product including overall accountability and reconciliation
      • Responsible for  the preparation of study  budgets and timelines
      • Manage project timelines and vendor performance to meet departmental and corporate goals
      • Manage study budget and payment process for all clinical trial vendors including investigative sites
      • Monitor and track clinical trial progress and provide status update reports
      • Manage all clinical trial vendors
      • Responsible for selection of CRO study staff and coordinating training including documentation
      • Hire, train and oversee study Field Monitors (e.g., review of all trip reports) and provide guidance on site issues
      • Lead with minimal supervision in the planning of investigator meetings and making presentations, as required
      • Lead  the review of clinical data at the CRF, data listing, and report table levels
      • Represent Clinical Operations at the Project Team level for individual studies, as appropriate 
      • Partner with other research and development groups to achieve deliverables
      • Participate in Site Initiation Visits (SIVs) as required
      • Co-Monitoring of regional sites for adherence to protocol and GCP as required
      • Travel as required to carry out responsibilities
      • Identify and escalate site, vendor and study related issues to supervisor, as appropriate
      • Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner
      • Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals
      • Perform other duties as assigned

      EXPERIENCE AND QUALIFICATIONS:

      • Must have demonstrated expertise in relevant clinical operations activities
      • Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results
      • Good organization and planning skills
      • Strong interpersonal skills and communication skills (both written and oral)
      • Ability to problem solve and delegate appropriate tasks to subordinates
      • Knowledge of ICH/GCP guidelines and FDA regulations
      • Strong leadership skills, self-motivated, adaptable to a dynamic environment
      • Able to collaborate effectively with the study team, cross-functional team members, and external partners
      • Proficiency in MS Word, Excel and PowerPoint
      • Able and willing to travel approximately 25-30%  
      • 7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience)
      • Experience in oncology preferred
      • Experience in global trials preferred

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      178) Human Resources Assistant – Full Time (San Francisco Bay area)

      DESCRIPTION:

      • Set up and confirm candidate interviews with clients
      • Post job advertisements
      • Update company applicant tracking system
      • Find and submit qualified candidates for open positions in the client facilities. 
      • Must have exceptional interpersonal skills to manage the recruitment database, post jobs, generate leads, pre-screen and follow-up with candidates.
      • Other tasks as needed

      EXPERIENCE AND QUALIFICATIONS:

      • Excellent computer skills: Applicant tracking systems; database experience, Microsoft Word, Excel, Outlook
      • Bachelor’s degree strongly preferred -- BS/BA in Biology or Life Science preferred.
      • Must be self-motivated, present well and be able to develop relationships with candidates and individuals at all levels of the of the organization.
      • Ability to navigate through change and demonstrate flexibility as organizational needs shift.
      • Excellent organizational skills and the ability to work independently are extremely important.
      • Must live in the United States or Puerto Rico and have U.S. work status.  San Francisco Bay area preferred.

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      179) Internal Auditor III (Finance) – Full Time Position (San Francisco Bay Area) H95TJ

      DESCRIPTION:

      • Conducts internal financial audits and risk assessments. 
      • Performs and documents financial records for integrity and transaction accuracy. 
      • Identifies control and process deficiencies and reports discrepancies. 
      • Prepares audit plans and understands the specific issues to be evaluated. 
      • Executes internal audits of established business process controls. 
      • Develops formal written reports to communicate audit results to management and makes recommendations as appropriate. 
      • May facilitate work of external auditors during on-site visits. 
      • Requires audit knowledge and skills in finance/accounting and/or information system operations.
      • Up to 25% international travel may be required.

      EXPERIENCE AND QUALIFICATIONS:


      • 3-5 years current experience in a Big 4 Accounting Firm or second tier firm.
      • Forensic accounting experience is a plus.
      • Finance investigation experience is a plus.
      • CFE, CPA or CIA certifications a plus.
      • Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint. Experience with SAP ERP software desired. 
      • Domestic and possibly international travel will be occasional.
      • Bachelors degree and 5 years of related experience or Masters Degree with 3 years of related experience.


      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      180) CRAII / Senior Clinical Research Associate II (SCRA) – Contract or Full Time Position (San Francisco Bay Area) B80CR

      DESCRIPTION:

      • Reports to Clinical Program Manager (CPM).
      • May review and edit documents including protocols, informed consents, case report forms, monitoring plans, edit specifications, abstracts, presentations, manuscripts and clinical study reports
      • May write protocols and protocol amendments, with supervision
      • Will present at investigator meetings
      • May manage CROs and/or contract CRAs with guidance from CPM
      • Chair or participate in meetings or conference calls with CROs and multi-disciplinary study team
      • Assist in review of data and preparation of safety, interim and final study reports, and resolution of data discrepancies
      • Assist in setting and updating study timelines
      • Participate in abstract preparation, presentation preparation and manuscript development
      • Train clinical site staff to ensure protocol and regulatory compliance. May assist in training CRA I and CRA Assistant

      EXPERIENCE AND QUALIFICATIONS:

      • Bachelor’s degree in a relevant scientific discipline or equivalent
      • At least 3 years Clinical Operations Pharmaceutical experience for CRAII; and at least 5.5 year of relevant experience as a CRA in the biotech / pharmaceutical (not diagnostics / device) industry in an in-house (not Regional monitor, CRO or Hospital / Site based position) for SCRA.
      • Phase 3 experience, Study start-up experience, and Global trial experience are desirable
      • Must have some experience with direct monitoring of sites (in order to manage the CRO; direct monitoring is not part of this job)
      • Experience in a start-up environment preferred
      • Knowledge of GCP and ICH guidelines
      • Ability to work collegially within a team
      • Able to perform routine assignments with general instructions and new assignments with detailed instructions
      • Must be able to go on occasional travel (this is an in-house position so very little travel is expected)
      • Proficiency with MS Word, Excel, Outlook, and PowerPoint
      • Basic Relocation Provided

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      181) Clinical Program Manager – Full Time Position (San Francisco Bay Area) R80BS

      DESCRIPTION:

      Clinical Program Manager to manage multiple clinical trials.

      • Reports to Director level
      • Manage late stage global clinical study teams, CRO’s and Vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
      • Manage CRA to SCRA level clinical operations personnel

      EXPERIENCE AND QUALIFICATIONS:

      • Bachelor’s degree in a relevant scientific discipline or equivalent
      • At least 7 years of relevant clinical experience in the pharmaceutical industry or equivalent with 3+ years as a CRA in biotech or Pharmaceutical clinical operations (not a device or diagnostics company) environment, and 1 year prior experience as a CPM preferred
      • 1+ years managing staff/direct reports preferred
      • Must be hands on and used to a start-up environment
      • Knowledge of GCP and ICH guidelines required
      • Proficiency in the implementation, monitoring, and management of clinical trials
      • Able to work collegially within a team and carry out duties/responsibilities with general instructions
      • Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project
      • Must be willing to travel occasionally (this is an in-house position so very little travel is required)
      • Previous experience as a CPM managing more than one trial in Phase 3 or a large Phase 2B trial
      • Study start-up experience is highly desirable
      • Global (Asia, Europe, South America, Middle East, or Africa) trial experience is highly desirable
      • Demonstrated stellar track record in the oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities.
      • Basic relocation provided

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      182) Biotechl Recruiter / Sourcing Specialist – (Full Time or Part-time, San Francisco Bay area preferred)

      DESCRIPTION:

      We have openings for several recruiters and are therefore flexible in terms of full or part time.

      • Primary responsibilities are to source open positions with qualified candidates
      • Document/track recruiting activities in candidate tracking system.
      • Source, screen and interview candidates
      • Prepare candidate summary for submission to the Account Manager
      • May also act as Account Manager depending on experience or recruiter
      • Other work as assigned (e.g. attend networking meetings, do job postings etc.)

      EXPERIENCE AND QUALIFICATIONS:

      • Must have minimum of 4 years of solid recruiting experience.
      • Experience must be with Pharma, diagnostics or medical devices companies.
      • Prior experience and absolute comfort with making cold calls
      • Must be self-motivated, present well and be able to develop relationships with candidates.
      • Should feel comfortable representing the company at networking meetings
      • Ability to navigate through change and demonstrate flexibility as organizational needs shift.
      • Excellent organizational skills and the ability to work independently is very important
      • Must develop and implement creative sourcing strategies to identify talent in addition to utilizing company sourcing tools
      • Bachelor degree required
      • Must live in the United States and have U.S. work status;  Residence in California especially the San Francisco Bay area preferred

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      183) Clinical Laboratory Scientists (CLS)/Research Associate (RA) – Full Time Position (San Francisco Bay Area) BD64G

      DESCRIPTION:

      Responsible for performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures and complying with all applicable local, state and federal laboratory requirements. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules and the ability to work independently in a team environment.

      Principal responsibilities include:

      • Perform laboratory tests, procedures and analyses according to the laboratory’s standard operating procedures.
      • Perform, review and document laboratory quality control procedures.
      • Operate, maintain and troubleshoot laboratory equipment.
      • Prepare reagents required for laboratory testing.
      • Review, interpret and report patient results.
      • Independently identify and troubleshoot basic problems that adversely affect test performance.
      • Report all concerns of test quality and/or safety to the Supervisor or Safety Officer
      • Assist with final development of protocol and processes for a Laboratory Developed Test and perform other duties as assigned.

      EXPERIENCE AND QUALIFICATIONS:

      • Proven successful track record and comfortable with a start-up environment.
      • Must possess a valid California CLS license, generalist preferred.
      • Completion of a CLS training program at an accredited institution or clinical laboratory work experience within the last five years.
      • Possess working knowledge of local, state and federal laboratory regulations.
      • Computer skills a must, automation skills preferred.
      • Ability to analyze and problem solve basic issues that impact test performance.
      • Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed.
      • Must communicate effectively with coworkers and non-laboratory personnel
      • Able to integrate and apply feedback in a professional manner.
      • Able to manage daily test processing needs with high emphasis on quality.
      • Ability to work as part of a team.
      • Ability to perform repetitive tasks.
      • High volume laboratory experience preferred.
      • Training in molecular biology techniques preferred.

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      184) Associate Director – Full time Position (San Francisco Bay Area) Y132Q

      DESCRIPTION:

      • Lead functional work process optimization, continuous improvement, and change management in partnership with Clinical Operations leadership team colleagues [Study Management, Site Contracting, and Clinical Monitoring] for global clinical trials.
      • Line management of CTA Manager(s),Clinical Trial Associates (CTAs) , and other functional members as needed
      • Provide leadership, operational expertise and guidance as a point of escalation for clinical operations coordination issues.
      • Ensure that employees complete assigned project tasks on schedule and meet/exceed the expectations of that project.
      • Performance management: Tasks include and are not limited to: setting/communicating performance standards; performing ongoing performance management activities including individual goal setting/periodic performance assessments/timely performance feedback/coaching/development planning; and tracking and monitoring attendance/timesheets/expense reports. Identify and address performance issues and training needs.
      • Develop and track FTE resourcing requirements and participate in headcount planning.
      • Lead interviewing, hiring, training, mentoring, and personnel development activities within area of functional responsibility.
      • Interact with Study Teams to ensure consistent functional performance and quality of work.
      • Strategically assess metrics and ensure implementation of appropriate measures as necessary to support project or program targets / deliverables.
      • Lead strategic planning and process development/ implementation for the function(s), tracking timelines to remain on schedule, and developing contingency strategies, if needed.
      • Ensure GCP/ICH and Standard Operating Procedures (SOP) compliance and implementation across clinical trials.
      • Lead/participate in meetings to plan and implement cross-functional operational activities to increase quality, productivity, and efficiency within Clinical Operations.
      • Ensure effective and efficient collaboration between internal customers and external providers (CROs). Liaise with internal (Study Management, Site Contracting, Central Services, etc.) and external (investigational sites and vendors) partners/stakeholders to assess functional team processes/performance and opportunities for development/enhancement.
      • Collaborate and work effectively with other functional managers to establish high quality and efficient processes and ensure consistency and alignment throughout the team.
      • Maintain clear lines of communication with functional managers to ensure high quality deliverables are met.

      EXPERIENCE AND QUALIFICATIONS:

      • BA/BS or equivalent degree in life sciences or allied health field.
      • Minimum of 8 years experience in clinical operations roles, including at least 3 years of global clinical trial experience. Oncology or other complex clinical indication experience required.
      • Phase 2 or 3 experience required.
      • Line management experience preferred.
      • Excellent people interaction and communication skills, strong professional diplomacy and positive attitude a must.
      • Ability to foster a collaborative team environment, motivate others, work in teams in a matrix environment and with various levels both within company and with vendors as appropriate.
      • Excellent problem solving ability, detail oriented, excellent organizational skills, ability to multi-task, re-prioritize duties, and work effectively in a fast paced matrix environment.
      • Demonstrated competency in leading cross-functional process improvement efforts.
      • Demonstrated leadership and management skills, prior supervisory experience with demonstrated success in managing people, and expertise in mentoring and coaching.
      • Financial budgeting and resourcing planning skills.
      • Solid knowledge of ICH/GCP, regulatory guidelines/directives and drug development process. Knowledge of medical terminology.
      • Strong computer skills to include MS Office: Word, Excel and PowerPoint.
      • Excellent oral/written/presentation – communication skills.
      • Cross-functional and cross-cultural awareness.

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      185) R&D Software Developer Medical Technology – Full Time or Contract Position (San Francisco Bay Area) L74HT

      DESCRIPTION:

      • Design, develop and prototype pattern recognition, data collection and data processing algorithms
      • Use various software tools for processing and visualization of the experimental data
      • Work closely with interdisciplinary development team on acquisition and processing high quality data
      • Participate in digital signal processing algorithm development
      • Write documentation and white papers on algorithms, data processing and data presentation
      • Participate in definition of features, functionality and other software requirements

      EXPERIENCE AND QUALIFICATIONS:

      • Excellent written and oral communication skills
      • Experience in object oriented design and development
      • Knowledge of Linux and Windows operating systems
      • Experience in Qt and/or .NET frameworks
      • Familiarity with source code control tools preferably Mercurial (Hg)
      • Experience in grant proposal writing
      • MS/PhD in Computer Science, Math or Physics
      • Strong knowledge of pattern recognition and signal processing algorithms
      • Strong knowledge of statistics and data processing
      • Experience in MATLAB and Scilab
      • Experience in software development using C++ or other object-oriented language
      • Experience in data presentation and visualization

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      186) Clinical Laboratory Scientists (CLS)/Research Associate (RA) – Full Time Position (San Francisco Bay Area) BD64G

      DESCRIPTION:

      Responsible for performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures and complying with all applicable local, state and federal laboratory requirements. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules and the ability to work independently in a team environment.

      Principal responsibilities include:

      • Perform laboratory tests, procedures and analyses according to the laboratory’s standard operating procedures.
      • Perform, review and document laboratory quality control procedures.
      • Operate, maintain and troubleshoot laboratory equipment.
      • Prepare reagents required for laboratory testing.
      • Review, interpret and report patient results.
      • Independently identify and troubleshoot basic problems that adversely affect test performance.
      • Report all concerns of test quality and/or safety to the Supervisor or Safety Officer
      • Assist with final development of protocol and processes for a Laboratory Developed Test and perform other duties as assigned.

      EXPERIENCE AND QUALIFICATIONS:

      • Proven successful track record and comfortable with a start-up environment.
      • Must possess a valid California CLS license, generalist preferred.
      • Completion of a CLS training program at an accredited institution or clinical laboratory work experience within the last five years.
      • Possess working knowledge of local, state and federal laboratory regulations.
      • Computer skills a must, automation skills preferred.
      • Ability to analyze and problem solve basic issues that impact test performance.
      • Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed.
      • Must communicate effectively with coworkers and non-laboratory personnel
      • Able to integrate and apply feedback in a professional manner.
      • Able to manage daily test processing needs with high emphasis on quality.
      • Ability to work as part of a team.
      • Ability to perform repetitive tasks.
      • High volume laboratory experience preferred.
      • Training in molecular biology techniques preferred.

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      187) Senior/Associate Director Program Manager – Full Time or Contract (San Francisco Bay Area) P73BY

      DESCRIPTION:

      The Program Manager for the Molecular Diagnostics (MDx) Business Unit manages the development of internally developed diagnostics products or companion diagnostics products co-developed with external partners. This responsibility requires involving departmental or cross-functional teams focused on the delivery of new products. Plans and directs schedules and may monitor budget/spending. Monitors the project from initiation through delivery. Organizes the interdepartmental activities ensuring completion of the project/product on schedule and within budget constraints. Has overall project management responsibility. In this role, direct people management responsibility is not required.

      Essential Functions:

      • Leads cross functional core team through product launch
      • Develops project plan and timeline
      • Coordinates with external Assay Partner teams to achieve project / product deliverables
      • Be the internal expert in PCP process and IVD project management.
      • Act as “mini GM” as leader of cross functional core team.
      • Act as communication liaison with Business Unit Management to assure deliverables are met, appropriate resources are applied and team(s) remains focused and engaged

      Competencies:

      • Facilitative leadership skills, particularly the ability to influence stakeholders in other functions over whom the Project Manager has no direct authority. Must be a highly-motivated driver able to complete tasks by leveraging relationships and established goals.
      • Has analytical skills, especially the ability to generate alternative solutions and manage risk by identifying criteria for trade-off decisions and helping to facilitate difficult conversations.
      • Willingness to be flexible and adaptable in a complex, matrixed environment. The ability to adapt to changing needs and parameters caused by time, budget, or other constraints
      • Discusses and presents factual information to other members of the team. Ability to convey very complex information in both written and oral form. Actively and constructively contributes to core team’s efforts through networking within the organization and effectively communicating to MDx management. Able to influence others and gain acceptance and build consensus.
      • Ability to manage moderately complex projects and initiatives.
      • Acts as a mentor/role model for team members.
      • Demonstrates understanding of company’s external customer needs and how they affect business unit products and services.
      • Makes decisions that involve the consideration of complex issues.
      • Works autonomously and checks-in as decisions are made.

      EXPERIENCE AND QUALIFICATIONS:

      • The candidate will have 3-5 years of project management experience in IVD product development
      • Experience with Device Design Control and biological/PCR based diagnostics is strongly desired
      • Working knowledge of design control and FDA QSR requirements
      • Microsoft Project Management skills
      • The candidate will have proven ability to execute through influence within a matrixed organization
      • The candidate will have an undergraduate degree in science or engineering. Additional advanced degrees are preferred but not required
      • In their repertoire, the candidate will be self-motivated & a driving force of execution in their current or past organizations
      • Experience working with external collaborators; Negotiations skills; Leading through influence
      • Strong written and verbal communication skills
      • Strong presentation skills
      • PMP certification is preferred

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      188) R&D Software Developer Medical Technology – Full Time or Contract Position (San Francisco Bay Area) L74HT

      DESCRIPTION:

      • Design, develop and prototype pattern recognition, data collection and data processing algorithms
      • Use various software tools for processing and visualization of the experimental data
      • Work closely with interdisciplinary development team on acquisition and processing high quality data
      • Participate in digital signal processing algorithm development
      • Write documentation and white papers on algorithms, data processing and data presentation
      • Participate in definition of features, functionality and other software requirements

      EXPERIENCE AND QUALIFICATIONS:

      • Excellent written and oral communication skills
      • Experience in object oriented design and development
      • Knowledge of Linux and Windows operating systems
      • Experience in Qt and/or .NET frameworks
      • Familiarity with source code control tools preferably Mercurial (Hg)
      • Experience in grant proposal writing
      • MS/PhD in Computer Science, Math or Physics
      • Strong knowledge of pattern recognition and signal processing algorithms
      • Strong knowledge of statistics and data processing
      • Experience in MATLAB and Scilab
      • Experience in software development using C++ or other object-oriented language
      • Experience in data presentation and visualization

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      189) Paralegal/Contracts Associate – Part Time Position 20 Hrs/week (San Francisco Bay Area) YR90W

      DESCRIPTION:

      Will work under the direction of the Contracts Manager and will be primarily responsible for all contract management duties within the department. Responsible for preparing and executing signature of contracts including, confidential disclosure agreements, consulting agreements, master service agreements, SOW, and other contract types. Shall provide professional legal support; drafting, reviewing and negotiating standard form contracts. Will manage the contract lifecycle for all corporate contracts, organize and maintain contracts database, provide contract review, interpretation of contract terms, and provide contract status updates and tracking.

      • Personal commitment to the company mission and vision.
      • Ability to identify problems and creatively solve them.
      • Superior communication skills both written and verbal.
      • Exceptional organizational and negotiation skills and attention to details.
      • Capable of prioritizing, handling multiple projects simultaneously and the ability to meet strict timelines.
      • Ability to maintain a positive attitude in a fast pace environment.
      • Willingness to share knowledge and train.
      • Demonstrate flexibility and ability to work independently and in a team/collaborative environment.
      • Interpret, draft and negotiate standard form contracts.
      • Guide other business function/department members on company contracts process as required.
      • Work with and support maintenance of the Legal Department’s contract request and database systems.
      • Maintain the workflow, prioritize, and complete multiple concurrent tasks in the face of constantly changing and competing priorities.
      • Provide and/or coordinate advice to internal clients on contract matters.
      • Ensure business activities and contracts comply with internal policies and guidelines, and industry laws and regulations.
      • Manage patent and trademark portfolio and coordinate with outside counsel as needed.
      • Manage the contracts database.
      • Monitor and track the status of contracts to ensure completion.
      • Know when to escalate to executive management any conflicts arising from contracts.
      • Train internal teams on contract forms and procedures.

      EXPERIENCE AND QUALIFICATIONS:

      • A bachelor’s degree or paralegal certificate is preferred with three (3) to six (6) years of relevant experience required.
      • Experience with drafting and negotiating contracts in a pharmaceutical or biotech industry, highly preferred.
      • Thorough understanding of the contract process including contract evaluation, negotiation, approval, tracking and close-out.
      • Experience with or knowledge of intellectual property and data privacy contract issues, highly preferred.
      • Experience with or knowledge of Pharma contract issues that overlap with FDA/pharmaceutical regulation is desirable, but not required.
      • The ideal candidate will be flexible and willing to learn new procedures and skill sets.
      • Strong computer literacy (Word, Excel and contract databases knowledge).

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      190) Manager, Sr. Manager, Regulatory Affairs CMC – Contract or Full Time Position (San Francisco Bay Area) Q77AB

      DESCRIPTION:

      Expertise with biologics and/or small molecule experience is essential. Manage CMC aspects of domestic and international regulatory affairs for multiple commercial and clinical projects. Responsible for obtaining and interpreting global CMC regulations and guidance and providing regulatory advice to Quality and Manufacturing team members.

      Work closely with CMC teams, corporate partners, and contract manufacturing organizations to prepare complete and accurate CMC submissions and meet established timelines. Responsible for interaction with global Regulatory authorities to ensure acceptance, rapid review, and approval of marketing applications, supplements, Variations, clinical trial applications, and other filings which present CMC information. Demonstrated strong communication and submission/ personnel management skills are required.

      • Plan, manage, and oversee preparation, and submission of global CMC submissions, including marketing and clinical trial applications.
      • Ensure that CMC content is complete, well-written, and meets all relevant requirements. Assess proposed manufacturing changes for global impact, and provide strategic regulatory guidance for optimal implementation of changes.
      • Provide regulatory advice to technical operations departments based on knowledge of current requirements.
      • Manage interactions with FDA or other regulatory authorities for assigned projects.
      • Develop excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.
      • May supervise one or more Associates.

      EXPERIENCE AND QUALIFICATIONS:

      • BA/BS degree in life sciences is required; advanced degree is a plus.
      • Required:
        • At least 5 years of experience in Regulatory Affairs or related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to both development and commercial phases of product lifecycle).
        • Experience in management and filing of marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the U.S. and/or Europe.
        • Experience in assessing post-marketing changes is critical.
        • Proven ability to lead cross functional CMC teams on projects and sub-teams.
        • Thorough understanding of relevant CMC drug development regulations and guidelines.
        • Outstanding interpersonal and communication (written and verbal) skills.
        • Proficiency with standard software programs (e.g., Word).
      • Preferred:
        • Proven ability to successfully interact with Regulatory Authorities.
        • eCTD experience is desirable.
        • Demonstration of effective skills in managing regulatory professionals.
        • Strong background in chemistry, molecular biology, or similar is desirable.

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      191) (Senior) Reliability Engineer Manufacturing & Production/ Industrial Manufacturing – Full Time Position (San Francisco Bay Area) S62BA

      DESCRIPTION:

      The Reliability Engineer II/Senior Reliability supports individual contributor activities in the areas of Reliability and Maintenance Engineering. The position reports to the Senior Manager of Process

      Engineering in the Technology Department. The Reliability Engineering group’s mission is to maximize equipment availability through the deployment of Reliability Engineering best practices in equipment design, assessment of operating equipment health, and structured root cause analysis of failed equipment in order to enable the site to meet the needs of patients through sustained equipment reliability.

      Responsibilities:

      Development and implementation of the overall site Reliability strategy and program, and support the incorporation of this into the site Integrated Risk Management program. Development, execution, analysis and optimization of:

      • predictive and condition based maintenance and monitoring programs, including lubrication, vibration, thermography, motor circuit analysis, eddy current, ultrasound, and corrosion trending.
      • reliability-centered maintenance, design and spares programs to ensure reliable asset operations and an optimized maintenance cost structure.
      • asset lifecycle strategies to support reliable operations and integration of asset retirement into site business planning processes.

      Execute Maintenance Engineering activities:

      • Determination of component/equipment repair, replacement, and retirement strategies.
      • Development, review and approval of repair procedures.
      • Technical reviews for spare parts requirements and obsolete component replacements.
      • Development and review of maintenance procedures and practices.
      • Review and revision of engineering specifications.
      • Audits of maintenance-related suppliers.

      Other duties:

      • Complete analysis and reporting of equipment performance metrics, and identification and prioritization of asset improvements.
      • Execute failure and root cause analyses to identify failure modes and causes to provide technical assessments.
      • Develop and implement recommendations to mitigate identified reliability risks.
      • Develop and deliver reliability and maintenance training to site maintenance, operations, and technical personnel.
      • Identify, develop, and implement industry and company network best practices into the Reliability and Maintenance Engineering programs.

      EXPERIENCE AND QUALIFICATIONS:

      • Bachelors of Science in Mechanical, Chemical or Electrical Engineering with a minimum of 8 years of experience in a Reliability and Maintenance Engineering role.
      • Advanced engineering degree and/or certification in maintenance and reliability, experience with SAP Plant Maintenance module, and cGMP knowledge is desirable.
      • Demonstrate strong proficiency in Reliability Engineering principles and techniques, and the successful application/implementation of this knowledge.
      • Demonstrate effective communication and interpersonal skills with technical and non-technical personnel, including Operations, Maintenance, Technology, Quality and Senior Management.
      • Work collaboratively across departments and lead cross-functional teams in the development, implementation, and sustainment of an overall Site Reliability Program.
      • Experience in industrial or pharmaceutical manufacturing facilities, knowledge in the use of computerized maintenance management systems, and Level 2 certification in lubrication, vibration, thermography and motor circuit analysis is preferred.
      • 7+ to 10 years of relevant experience.
      • No management experience required.
      • Willingness to travel – occasionally.

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      192) Senior Statistical Analyst/ Manager, Statistical Programming – Full Time Position (San Francisco Bay Area) JM96B

      DESCRIPTION:

      Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Generate Study specific and ad-hoc clinical data listings, summary tables and figures.

      • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
      • Create CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
      • Performs data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
      • Review Data Management Plan, data validation plan and edit check specifications.
      • Interact with statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
      • Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
      • Recognizes inconsistencies and initiates resolution of data problems.
      • Acts as a liaison between statistical programming, subcommittees and project teams as needed.
      • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
      • Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
      • Acts independently to determine methods and procedures on new assignments.
      • May provide guidance to other lower level personnel.
      • Generate and QC summary tables, data listings and figures for in-house analyses of study data or publications using SAS standard coding practices.
      • Validate work of other programmer/analysts at CRO or in-house.
      • Maintain complete and auditable documentation of all programming activities.
      • Works closely with biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP).
      • Create/acquire tools to improve programming efficiency or quality.
      • Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.

      EXPERIENCE AND QUALIFICATIONS:

      • Ability to use professional concepts to achieve objectives in creative and effective ways.
      • Experience in the analysis of complex Oncology clinical trial data.
      • Solid knowledge of CDISC standard (SDTM & ADaM).
      • Minimum 9 years Pharmaceutical/Biotech programming experience.
      • Experience working with Oncology trials required.
      • NDA submission experience is a plus.
      • Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
      • BS/MS in Statistics, Math or Scientific Discipline.

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      193) Associate Director/ Principal, Biostatistics – Full Time Position (San Francisco Bay Area) F96MP

      DESCRIPTION:


      DESCRIPTION:

      Responsible for designing, planning and conduct of clinical studies for a development molecule candidate. Contributes to technical and managerial leadership and organizational improvement. Responsible for providing leadership within the biostatistics department and making recommendations with regards to the strategic aspects of clinical studies as well as oversight of biostatistics activities.

      • Ensures that proper activities are undertaken for the timely and quality to meet corporate objectives.
      • Collaborates interdepartmental and scientific activities, especially collaboration with medical monitors on protocol design (author or supervisor statistical methods section and generate study randomization). 
      • Generate statistical analysis plan for assigned protocols (including mock displays).
      • Assume responsibility for individual studies, write statistical portion of integrated clinical/ statistical reports.
      • Develop statistical programs as necessary to perform analysis, prepare data displays, verify data accuracy and validity.
      • Supply statistical input for NDA submissions and in response to FDA queries.
      • Provide support for investigator publications.
      • Review case report forms to ensure that protocol objectives are met and project standards are maintained.
      • Responsible for ensuring compliance with departmental and company goals.
      • Effectively communicates timely and relevant updates to all team members involved.
      • Expected to lead projects or direct reports, and is responsible for ensuring and overseeing the work of others including mentoring of staff on all assigned clinical studies.


      EXPERIENCE AND QUALIFICATIONS:

      • Demonstrated sound knowledge of applied statistics and biostatistics and relevant experience in the application of statistics to medical trials.
      • Applies judgment and professional expertise independently.
      • Able to prioritize and handle multiple tasks simultaneously.
      • Prior management/supervisory experience (for Associate Director title).
      • 15 years related experience in clinical development in a pharmaceutical company. 
      • 2-5 years supervisory experience.
      • Previous experience with all phases of clinical research.
      • Previous experience in successful NDA.
      • Leadership in resource allocation, budget forecasting, project planning and implementation.
      • PhD in Biostatistics preferred.

      To apply for a position send your resume to Jobs@JGBBioPharma.com

      Back to Top

      linebreak

      Copyright © 2005-2014 JGB BioPharma Consulting Inc. All rights reserved.