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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.

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1) Sr. Clinical Research Associate – Contract (San Francisco or Greater Bay Area) AC166K

2) Document Control Specialist 1 – Contract to FTE (San Francisco or Greater Bay Area) P180FB

3) Staff Automation & Controls Engineer – Full Time (San Francisco or Greater Bay Area) BT162P

4) Manager/Senior Manager, Project Management – Full Time (San Francisco or Greater Bay Area) BY168A

5) Director Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) LP166W

6) Research Associate – Contract to FTE (San Francisco or Greater Bay Area) PA122T

7) Staff Project Engineer – Full Time (San Francisco or Greater Bay Area) Y162FN

8) Clinical Research Associate III/Sr. Clinical Research Associate – Full Time (San Francisco or Greater Bay Area) PA179G

9) Clinical Trial Manager – Full Time (San Francisco or Greater Bay Area) K178WE

10) (Associate) Director/ Principal Biotatistician – Full Time (San Francisco or Greater Bay Area) ZB178C

11) Sr Director Clinical Operations – Full Time (San Francisco or Greater Bay Area) PG166T

12) Clinical Trial Manager – Contract (Pennsylvania) 4338

13) Pharmacovigilance Writer – Contract (New York) GR177Z

14) Senior Clinical Program Manager, CNS – Full Time (San Francisco or Greater Bay Area) PS174A

15) Director / Associate Director, Document Control, Quality Assurance – Full Time (San Francisco or Greater Bay Area) JM174A

16) Director of Quality Assurance – Full Time (North Carolina) XT176B

17) Senior Project Manager, Business Technology Management – Full Time (San Francisco or Greater Bay Area) LQ166C

18) Sr. Manager, Clinical Operations, Oncology – Full Time (San Francisco or Greater Bay Area) G166AT

19) Manager, Clinical Operations – Full Time (San Francisco or Greater Bay Area) PD166N

20) Director Clinical Operations – Full Time (San Francisco or Greater Bay Area) BW175M

21) Manufacturing Site Training & Development Manager – Full Time (San Francisco or Greater Bay Area) F162XB

22) (Senior) Safety Associate – Full Time (San Francisco or Greater Bay Area) PH174A

23) Associate Director, Director Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) F166YL

24) Sr. Manager, Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) XA166R

25) Associate Director, Development Sciences Project Management, Oncology – Full Time (San Francisco or Greater Bay Area) TS166W

26) Regulatory Operations Specialist – Contract (San Francisco or Greater Bay Area) AT171H

27) SCRA / CTM – Full Time (San Francisco or Greater Bay Area) Q173DR

28) Sr. Clinical Operations Associate / SCRA – Full Time (San Francisco or Greater Bay Area) XA173P

29) Sr. Clinical Project Coordinator – Contract (San Francisco or Greater Bay Area) RE171B

30) Scientist I, II – Pharmacology/Tumor Immunology – Full Time (San Francisco or Greater Bay Area) AC171B

31) Director, Bioanalytical Development – Full Time (San Francisco or Greater Bay Area) M171JL

32) (Senior) Director Oncology Companion Diagnostics – Full Time (San Francisco or Greater Bay Area) TH171Q

33) Senior Scientist/Scientist III - Immuno-Oncology – Full Time (San Francisco or Greater Bay Area) K171BN

34) Director, Antibody Engineering – Full Time (San Francisco or Greater Bay Area) BA171X

35) Senior Administrative Assistant – Clinical Development & Regulatory – Full Time (San Francisco or Greater Bay Area) Z171GL

36) Clinical Program Manager, Clinical Operations – Full Time (San Francisco or Greater Bay Area) WE170Y

37) Senior Clinical Research Associate – Contract (San Francisco or Greater Bay Area) H170TP

38) Program Manager – Contract or FTE (San Diego) or Contract (San Francisco Bay Area) M167GB

39) Associate Project Manager – Contract or FTE (San Diego) or Contract (San Francisco Bay Area) PB167X

40) Executive Director, Clinical Operations – Full Time (San Francisco or Greater Bay Area) G166WA

41) Manager, Process Engineering – Full Time (San Francisco or Greater Bay Area) A146FV

42) Director/VP Regulatory Consultant – Contract (San Francisco or Greater Bay Area) GP164X

43) CRA II / SCRA – Contract 20 hr per wk (San Francisco or Greater Bay Area) P163AL

44) Staff Program Engineer (Validation/Compliance) – Full Time (San Francisco or Greater Bay Area) A162FT

45) (Sr) Director, Financial Planning & Analysis – Full Time (San Francisco or Greater Bay Area) A133FT

46) BioPharma Account Manager/ Recruiter – Full Time (San Francisco or Greater Bay Area)

47) Senior Clinical Research Associate – Full Time (San Francisco or Greater Bay Area) ER111Z

48) SCRA/Clinical Trial Manager – Full Time (San Francisco or Greater Bay Area) B111KN

49) (Senior) Manager, Statistical Programming – Full Time (San Francisco or Greater Bay Area) J111YT

50) Project Director – Full Time (San Francisco or Greater Bay Area) P113DQ

51) Director/Associate Director Clinical Scientist – Full Time (San Francisco or Greater Bay Area) B139MT

52) Senior Director / VP, Process Development & Manufacturing – Full Time (San Francisco or Greater Bay Area) FL161B

53) Field Service Specialist – Full Time (San Francisco or Seattle Area) D103GX

54) Product Management, Director – Full Time (San Francisco or Greater Bay Area) GZ146F

55) Senior Manager, Patient Advocacy Oncology – Full Time (San Francisco or Greater Bay Area) YR113J

56) Director of Portfolio & Program Management – Full Time (San Francisco or Greater Bay Area) AM146P

57) Senior CMC Regulatory Program Director – Full Time (San Francisco or Greater Bay Area) AB100Z

58) Senior Director - Clinical Operations – Full Time (San Francisco or Greater Bay Area) B139KP

59) Sr Assoc.Director/Director/ Sr Director, Biostatistics-Clinical Pharmacology – Full Time (Massachusetts) MP153G

60) Recruitment Account Manager – Contract or Full Time (San Francisco or Greater Bay Area)

61) CRA II / SCRA – Contract or Full Time (San Francisco or Greater Bay Area) GR132M

62) Senior Clinical Financial Analyst – Full Time Position (San Francisco or Greater Bay Area) RM133B

63) Field Application Scientist – Full Time (San Francisco or Greater Bay Area) BZ146J

64) Director, Biostatistics – Full Time (San Francisco or Greater Bay Area) D113HX

65) Associate Director / Director, Biostatistics – Full Time (San Francisco or Greater Bay Area) FM129R

66) QA Specialist / Sr. Quality Assurance Specialist – Full Time (San Francisco or Greater Bay Area) HN82Q

67) Staff Mechanical Engineer – Full Time (San Francisco or Greater Bay Area) PZ73N

68) Supply Chain Associate / Assistant – Full Time (San Francisco or Greater Bay Area) RA111H

69) Sr Mgr/AD Clinical Document Control & Training – Full Time (San Francisco or Greater Bay Area) GX82P

70) Team Leader (Sr Director to VP Level) – Full Time (San Francisco or Greater Bay Area) R155JM

71) Director / Sr. Director CMC Operations – Full Time (San Francisco or Greater Bay Area) BZ155F

72) Specialist / Sr. Specialist/Manager – Quality GCP Compliance – Contract or FTE (San Francisco or Greater Bay Area) RA82H

73) Manager, Process Engineering – Full Time (San Francisco or Greater Bay Area) A146FV

74) Clinical Trial Assistant – Full Time (San Francisco or Greater Bay Area) AP82R

75) CDM Systems Project Manager – Contract Position (San Francisco or Greater Bay Area) RP156B

76) Senior Medical Director / Medical Director, Clinical Development – Full Time (San Francisco or Greater Bay Area) YS139B

77) Regulatory Project Manager 1 – Full Time (San Francisco or Greater Bay Area) DY113R

78) (Senior) Manager, Regulatory Operations – Full Time (San Francisco or Greater Bay Area) JN113W

79) CDM Systems Project Manager – Contract Position (San Francisco or Greater Bay Area) RP156B

80) Director QA, GxP Quality Systems – Full Time (San Francisco or Greater Bay Area) F110JV

81) Chief Medical Officer – Full Time (San Francisco or Greater Bay Area) TG155B

82) Executive Human Resources Coordinator – Full Time (San Francisco Bay Area)

83) (Senior) Clinical Document Assistant – Full Time or Contract (San Francisco or Greater Bay Area) FH82P

84) Director, Clinical Operations – Full Time (San Francisco or Greater Bay Area) B151GQ

85) Sr Programmer / Principal Dataset Statistical Programmer – Full Time (Boston Area) GP153F

86) Director Project Manager – Contract (10 to 15 hrs/wk long term) (San Francisco or Greater Bay Area) GB152Y

87) CTM / Sr. CTM, Oncology or Pulmonary – Full Time (San Francisco or Greater Bay Area) JM82P

88) Clinical Program Manager – Full Time or Contract to Full Time (San Francisco or Greater Bay Area) G121PA

89) Project Team Leader/ Sr Director – Full Time (San Francisco or Greater Bay Area) RY151F

90) CTM / Senior CTM – Full Time (San Francisco or Greater Bay Area) GA139X

91) Associate Director / Director of Quality Assurance – Full Time or Consultant (San Francisco or Greater Bay Area) P150WB

92) Senior Director – Project Team Leader – Full Time (San Francisco or Greater Bay Area) A139JX

93) Clinical Program Manager – Full Time (San Francisco or Greater Bay Area) G149PR

94) Statistical Programmer Manager / Associate Director – Full Time (San Francisco or Greater Bay Area) MG140P

95) Senior HFM Analyst – Contract (Southern California)

96) R&D Scientist (Senior Scientist) – Full Time (San Francisco or Greater Bay Area) W146KQ

97) Senior Global Project Manager – Full Time (San Francisco or Greater Bay Area) B100FQ

98) Biostatistics Sr Manager / Associate Director/ Director – Full Time (San Francisco or Greater Bay Area) J140FB

99) (Senior) VP Medical Oncology – Full Time (South San Francisco) ZR121P

100) (Senior) Bioinformatics Scientist – Full Time (New York) GP143V

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

102) CTM / Associate Director Clinical Operations – Full Time (San Francisco or Greater Bay Area) A129DK

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

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

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

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

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

108) Biotech Recruiter / Sourcing Specialist – Full Time or Part Time (San Francisco Bay Area)

109) CRA – Full Time (San Francisco or Greater Bay Area) XB128G

110) Recruiting Assistant – Part Time Position (San Francisco Bay Area Preferred)

111) Sr Human Resources Coordinator/ Associate / Manager – Full Time (San Francisco Bay area)

112) Recruiting Coordinator – Full Time (San Francisco Bay Area)



1) Sr. Clinical Research Associate – Contract (San Francisco or Greater Bay Area) AC166K

DESCRIPTION:

  • Participates in the planning, oversees, and is accountable for the conduct of clinical studies, with a strong focus on enrollment, quality of data, site relationships, and oversight of challenging and/or complex studies.
  • Regularly represents department in team meetings, leads teams and drive collaborative efforts (protocol development, CRO selection).
  • Oversees and is accountable for feasibility assessments for new studies.
  • Responsible for TMF contents and accountable for TMF reconciliation.
  • Oversee and accountable for content of study documents (consents, study instructions).
  • Oversee and accountable for content of study workshops and investigator meeting materials and presents at study training workshops and investigator meetings.
  • Development and management of study start-up, maintenance, and close-out activities, including the development of the monitoring plan.
  • Adherence to timelines, study quality, budget for assigned studies and participates in timeline development.
  • Preparation of training materials and training of internal and external staff involved in the study team.
  • Oversee vendor identification and evaluation process including RFP development.
  • Consistency and quality of content of clinical protocols and amendments and leads the protocol development process.
  • Development and completion of individual site recruitment and back-up plans and is responsible for the development of risk mitigation and contingency plans to keep trial enrollment on target.
  • Oversight of all monitoring of clinical sites, may include complex or challenging studies and sites.
  • Identification and qualification of clinical investigators and assists in the selection of investigators.
  • Development of investigator site budgets, manages routine site budget negotiations and assists with more complex site budget negotiations.
  • Development of the vendor evaluation and selection process and development of vendor budget.
  • Responsible for drafting Central Ethics Committee applications for studies conducted outside of the United States
  • Responsible for providing input in eCRF content development
  • Responsible for the assessment and management of vendor performance and in collaboration, develops and manages performance metrics.
  • Direct supervision of internal personnel including annual performance reviews and assists in the development of long-term professional development plans for direct reports.

EXPERIENCE AND QUALIFICATIONS:

  • 4-6 years industry experience, including a minimum 4 years clinical research experience.
  • Competent in the skills for the CRA II
  • Experience in line management and/or mentoring of CR Assistants and CRAs
  • Contributes in process improvement teams
  • Understanding of the clinical development plan and how the individual projects are impacted
  • Demonstrates understanding of CRO and other vendor roles
  • Strong knowledge of the Code of Federal Regulations FDA guidance, CFR Title 21 and ICH GCPs.
  • Ability to travel is required
  • Bachelor’s degree in biological science preferred.
  • Combination of educational and work experience providing competencies to perform the required accountabilities specific to position.

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

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2) Document Control Specialist 1 – Contract to FTE (San Francisco or Greater Bay Area) P180FB

DESCRIPTION:

  • Help mitigate the departure / transition of current document control manager
  • Assist with documenting current work practices, cataloguing all document locations, creating document maps as a baseline for improvements
  • Support Regulatory and QA with outstanding filing and reorganizing of existing records to ensure all critical documents are secure and readily retrievable
  • Assist with development of a complete document inventory, including scanning and reconciling electronically available documents against their hardcopy counterparts
  • Assist with preparing records for offsite archiving, including obtaining review/approval, creating inventory sheets, and updating (and consolidating) trackers
  • Assist with assessment, clean up, and standardization of current GxP employee training files
  • Assist with document processing across all departments, as needed (document formatting, annotation reconciliation, table standardization, template checking, cross-reference checking, converting to PDF)

EXPERIENCE AND QUALIFICATIONS:

  • Quality experience
  • Detail oriented
  • Strong organizational skills
  • Background of Executive Assistant who has supported C-level
  • Document control experience
  • Microsoft Office
  • Adobe software
  • Document management is a plus

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

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3) Staff Automation & Controls Engineer – Full Time (San Francisco or Greater Bay Area) BT162P

DESCRIPTION:

  • Providing technical and sustaining engineering support for product manufacturing and development control systems.  
  • Establishing operating equipment specifications, improves manufacturing techniques and production yields, and introduces new process equipment to improve production efficiencies.  
  • Interacts with product design and development personnel to ensure that processes and designs are compatible.
  • Leading cross discipline project team and provide technical expertise, guidance and judgment.
  • Participating in site wide initiatives and global best practice networks (BPN) to set technical benchmarks locally and globally
  • Provides automation systems support for 24x7 manufacturing operations 
  • Participate in after hours and weekend on call support rotation
  • Programs and troubleshoots PLC's, distributed controls systems and other controllers as required.
  • Programs and configures various types of man-machine interfaces and SCADA systems.
  • Provides documentation to aid in the qualification and validation of automated, computer-controlled systems.
  • Provides system installation, start-up and qualification assistance as required.
  • Serves as project manager or project engineer and as a designated contact on capital and expense projects. 
  • Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
  • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
  • Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
  • Determines methods and procedures on new assignments. 
  • Calculates, using engineering formulas and skills for design, instrumentation selection, process control, statistics and other equipment sizing.
  • Provides drawings for own designs and produce sketches to be incorporated in drawings by drafters.
  • Researches design options and documents findings.
  • Reviews shop drawings.
  • Develops probable construction cost estimates for projects within the department.
  • Handles contract administration.
  • Uses computer-assisted engineering and design software and equipment to prepare engineering and design documents.
  • Participates / leads the Automation team in system life cycle planning and execution.
  • Ensures compliance with GMP/HSE regulations, policies, procedures and standards as appropriate for the role.  
  • Champions a Quality Culture and ensures a safe working environment
  • Plans, proposes and secures personnel and financial support for projects

EXPERIENCE AND QUALIFICATIONS:

  • Requires a minimum of 15+ years related work experience.
  • Must be very comfortable with 21 CFR Part 11 and GAMP.
  • Must have 5 years experience in a GMP pharmaceutical manufacturing environment or other regulated environment.
  • Experience with computer-assisted engineering and design software, CAD and graphics skills are a plus.
  • Batch processing and/or filling/packaging controls experience are a must.
  • BMS experience is a plus.
  • Must possess sound technical judgment and use structured decision-making techniques.
  • Good oral and written communication skills are a must.
  • Strong computer skills are required.
  • Must have an ability to provide technical engineering support in a collaborative, team-oriented project environment.
  • Project management skills are a plus.
  • Requires a Bachelors degree in an engineering or related discipline. Equivalent experience may be accepted

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

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4) Manager/Senior Manager, Project Management – Full Time (San Francisco or Greater Bay Area) BY168A

DESCRIPTION:

  • Supports Sr Project Management staff and works with the Project Team Lead in coordinating all aspects of communication and activities related to a late-stage BLA-ready project. 
  • Prepare for, attend, and follow-up for internal working group meetings; create and manage critical cross-functional timelines; coordinate the document review process; manage the project files; prepare project activity tracking reports; and provide project management support to the clinical development organization.
  • Establish and maintain functionally integrated project schedules and other tracking tools to enable accurate project management across various functional areas
  • Work closely with the Clinical Operations, Clinical Development and Data Management groups to publish and track clinical metrics
  • Schedule, organize, and drive project team meeting(s): prepare and distribute agendas/minutes; track action items, and escalate areas of concern to appropriate management entity
  • Facilitate communication of sub-team issues & outcomes to the Core Team/Project team leader
  • Manage the interfaces between functional areas and ensure effective handoff and communication between department functions to execute on important project milestones
  • Works with project Lead and/or SME to prepare status reports, specific project updates, or scenarios
  • Manage document review practice to support BLA submission activities and other key project deliverables

EXPERIENCE AND QUALIFICATIONS:

  • A BA or BS degree in the Life Sciences
  • The ideal candidate will have at least 4 years multi-disciplinary experience in the biotech/pharmaceutical industry, with at least 2 years direct project management in drug development, and PMP (Project Management Professional) certification or equivalent a plus
  • Relevant experience consists of work with specific experience in Clinical Operations, biotech or pharma association with R&D project teams and/or in cross-functional project management activities
  • Advanced proficiency and experience using Project Management software (including MS project, Excel, Word, Visio and PowerPoint) to manage and maintain complex project timelines
  • Experience with BLA/NDA submissions preferred
  • Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills
  • Results and detail-oriented; self-motivated
  • Ability to perform in a fast-paced environment under tight deadlines

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

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5) Director Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) LP166W

DESCRIPTION:

  • Leads an interdisciplinary regulatory team responsible for defining and implementing global regulatory strategy, including plans to submit global marketing applications.  
  • Provides regulatory leadership on cross-functional development teams.  
  • Leads interactions with global health authorities and corporate partners.  
  • Continues to expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs and biologics. 
  • Lead interdisciplinary regulatory team in establishing global regulatory strategy for late-stage development
  • Oversee planning, preparation, and submission of clinical trial applications and marketing applications in the US and internationally
  • Provide strategic regulatory insight to the project team regarding product development
  • Lead interactions with regulatory health authorities
  • Manage and mentor multiple manager-level and associate-level direct reports (3 direct reports)
  • Communicate with regulatory consultants regarding product development plans
  • Interact with executive leadership team to discuss global regulatory plans

EXPERIENCE AND QUALIFICATIONS:

  • Proven track record of managing a marketing submission (NDA, BLA, MAA etc) as the lead or a participant with a large amount of responsibility as part of of the team and the ability to take the lead role at this time.
  • Skilled at gathering supportive information and developing product approval strategies
  • History of achieving regulatory goals in ambiguous and sometimes challenging situations
  • Proven track record of successfully interacting and negotiating with regulatory health authorities
  • Prior experience leading cross-functional teams in the coordination of regulatory submissions and successfully managing projects to deadlines
  • Global regulatory experience preferred (EU and USA etc.)
  • Outstanding interpersonal and communication (written and verbal) skills
  • Effective task planning and coordination abilities
  • History of solving regulatory problems while exhibiting superior judgment and a balanced, realistic understanding of issues
  • Experience in managing regulatory staff preferred but not required
  • MD, PharmD, or PhD, preferably in a science related to medicine and minimum of 6 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry with a clinical and nonclinical emphasis, or
  • MS degree with 8+ years of experience described above, or
  • Bachelor's degree with 10+ years of experience described above

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

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6) Research Associate – Contract to FTE (San Francisco or Greater Bay Area) PA122T

DESCRIPTION:

  • Create standard curves with accuracy and precision, and modify gradients to enhance performance.  
  • Prepare  mobile phase.  
  • HPLC (C-18 RP-HPLC).
  • HPLC Potency assays (Standard curves).
  • Aerosol Test methods (will be trained).
  • Cascade impactor MMAD
  • Emitted dose
  • Ultraviolet spectroscopy assay.
  • Buffer preparations.
  • Formulation stability study time points.
  • Ordering lab consumables.

EXPERIENCE AND QUALIFICATIONS:

  • QC background is a plus.  
  • Solid understanding of a pH and buffers.  
  • The ability to be flexible and work independently. 
  • Excellent  ability to document your work in a notebook. 
  • RP-HPLC experience.  
  • Protein experience is a plus.  
  • Exposure to Waters Empower Software  mandatory.  
  • Detail oriented and fluent with concentration/dilution equations (Ci  x Vi = Cf x Vf). 
  • BS in chemistry or related life science 2+ years  experience

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

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7) Staff Project Engineer – Full Time (San Francisco or Greater Bay Area) Y162FN

DESCRIPTION:

  • Takes the leadership role on assigned projects, plans, conducts, coordinates, and executes assigned project work. 
  • Monitors work for compliance to applicable codes and standards. Implements comany policies, guidelines, and procedures in support of good manufacturing engineering practices. 
  • Manages multiple, concurrent projects and/or high-value capital projects. Manages engineering consultants and contractors as required. 
  • High degree of independent decision making, professionalism, project management skills and experience is required. 
  • Interacts with process development, manufacturing, automation and controls, facilities, quality and design engineering groups in design, scale-up and hand-off of technology transfers to clinical and commercial manufacturing along with facilitating, documenting, and providing equipment commissioning and qualification support. 
  • Establishes and oversees manufacturing process and engineering continuous improvement projects. 
  • Develops cost/performance models, where necessary, for project justifications. 
  • Supports the preparation of all manufacturing and support documentation (SOP’s, PM’s, Spare Parts Lists). 
  • Demonstrates working knowledge of manufacturing equipment and processes, automation technology, commissioning, and qualifications. 
  • Demonstrates working knowledge of application of engineering to plant constructability as applied to construction methods and materials, and the economics involved. 
  • Performs assignments independently with minimal guidance as to the general results expected, often times dealing with unusual or complex problems. 
  • Provides direction and regular contact to consultants, vendors and contractors assigned to the project. 
  • Ensures effective communication and coordination on assigned projects between all parties. 
  • Plans, schedules, and coordinates: engineering, construction, qualification, and validation activities for projects. 
  • Perform project cost estimating, project controls, and project manpower planning functions. 
  • Analyze, prepare, and/or review reports, studies, specifications, drawings, test plans, and other data to execute work. 
  • Oversee preparation of documents for bid, approval, and construction/fabrication use. 
  • Prepare and/or review bid analyses and make recommendations for contract awards. 
  • Prepare or review construction drawings, P&IDs, equipment, materials, and construction specifications, turnover packages, as-built drawings, and material requisitions. 
  • Select project engineering personnel and/or consultants. 
  • Participate in jobsite visits, meetings and presentations. 
  • Achieve quality, schedule and budget targets on assigned projects. 
  • Keep site management informed of all circumstances that could affect projects. 
  • Prepare monthly project reports detailing project progress. Scope, schedule, cost and quality is-sues relating to the project shall be addressed in the monthly report.  
  • Keep abreast of best practices as they relate to project engineering and project management. 
  • Attend technical and professional society meetings and seminars. 
  • Ensures compliance with GMP/HSE regulations, policies, procedures and  standards as appropriate for the role. Champions a quality culture and ensures a safe working environment. 

EXPERIENCE AND QUALIFICATIONS:

  • A minimum of 10 years industry work experience is required. 
  • Must have 8 years experience in project engineering or project management role. 
  • Previous supervisory experience is preferred. 
  • Formal project management training and/or certification is desirable. 
  • Extensive Project Management experience associated with continuous improvement. 
  • Excellent management, leadership and communications skills. 
  • Creative problem solving and trouble shooting skills. 
  • FDA, regulatory, and agency compliance experience is essential. 
  • Must be able to demonstrate working knowledge of engineering principles and concepts. 
  • Must be a team player with excellent interpersonal skills. 
  • Excellent communication skills, both writ-ten and oral are required. 
  • A working knowledge of regulatory requirements for pharmaceutical industry is required. 
  • Demonstrated technical writing skills in support of regulatory filings is a plus. 
  • Good documentation and record keeping skills and attention to detail are essential. 
  • Must possess excellent technical judgment and use structured decision-making techniques. 
  • Must be able to demonstrate influencing and persuasion skills with an ability to drive decisions with executive staff. 
  • Computer literacy and documentation skills. 
  • Proficient at Microsoft Project.
  • A minimum of a Bachelors degree in an engineering discipline is required. Equivalent experience may be accepted. 

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

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8) Clinical Research Associate III/Sr. Clinical Research Associate – Full Time (San Francisco or Greater Bay Area) PA179G

DESCRIPTION:

  • Independently design, plan and implement, and provide overall direction of clinical research projects.  
  • Managing all aspects of unblinded assigned clinical studies to ensure studies are completed on time, within budget, and in compliance with Good Clinical Practice (GCP), government regulations, and overall clinical objectives.  
  • Develop protocols, investigator brochures and study reports, and assist in new drug applications.  
  • Will function with greater independence and may lead and supervise lower level staff.
  • Daily activities will vary depending on the clinical phase of the program.  Will have responsibilities for managing more than one project.  Determine methods and procedures for performing new assignments.  
  • May oversee the activities of CTAs and CRAs. 
  • Manage contract research organization (CRO) personnel and study sites to ensure studies are completed on time, within budget and in compliance with the protocol, GCPs, FDA regulations and ICH/GCP guidelines, and overall clinical objectives.  
  • Manage all study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out.  
  • Supervise monitoring activities of study data verification on source documentation and case report forms (CRFs) to ensure compliance with the study protocols, GCPs, and SOPs.  Ensure data discrepancies are identified and resolved. 
  • Supervise on-site monitoring visits, including site qualification, initiation, interim, co-monitoring with CRO, and close-out visits.  Review site visit reports. 
  • Supervise activities related the preparation of all study-related clinical documents including, but not limited to, informed consent forms, site training materials, CRFs, clinical monitoring plans, source document templates, and data audit worksheets. 
  • Lead the evaluation and selection of sites and CROs, and planning of clinical meetings (investigator meeting, steering committee meeting, CRO meetings) 
  • Broad knowledge of FDA and ICH regulatory requirements. 
  • Assist in the preparation of study protocols, and the clinical sections of INDs and other regulatory submissions. 
  • Assist in the analysis of clinical trial data and prepare clinical study reports. 
  • May be the lead clinical operation representative in project team meetings. 
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork. 
  • Travel is required – up to 25%. 

EXPERIENCE AND QUALIFICATIONS:

  • Experience in one or more of the following therapeutic areas:  oncology, allergy, autoimmune, and infectious disease. 
  • Demonstrated management experience of regional and in-house CRAs a plus. 
  • Broad knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical trials. 
  • Proven ability to exercise independent judgment, use critical-thinking to analyze problems which may require multiple factors and approaches.  
  • Excellent technical writing skills. 
  • Proven experience working in cross functional project teams. 
  • Excellent communication and interpersonal skills. 
  • Computer proficiency. 
  • Flexibility and integrity
  • Experienced with successfully juggling multiple teams, external sites and projects in a dynamic environment
  • Proactive in spotting potential problems and seeking successful solutions
  • Action and goal oriented
  • Practical approach to clinical and regulatory processes
  • Good judgment and decision-making experience
  • Collaborative and team-oriented
  • Excellent attention to detail 
  • Research Associate III, a BS, RN/PA, BSN degree or equivalent, with 5+ years’ in-house clinical research experience in the biotechnology industry.  
  • The Senior Research Associate will have at with 8+ years of clinical research experience, of which at least 5 years must be industry in-house experience. 

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

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9) Clinical Trial Manager – Full Time (San Francisco or Greater Bay Area) K178WE

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.
  • 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 (IVRS, central labs, IRB, and central ECG)
  • 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

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
  • Knowledge of ICH/GCP and FDA regulations
  • 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
  • Education Requirements:
  • BA/BS/MS in a scientific discipline

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

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10) (Associate) Director/ Principal Biotatistician – Full Time (San Francisco or Greater Bay Area) ZB178C

DESCRIPTION:

  • Responsible for designing, planning and conduct of clinical studies for a development molecule candidate. 
  • Maintains departmental infrastructure and procedures and ensures adherence to standards, and all applicable regulations and guidelines. 
  • 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
  • 15 years related experience in clinical development
  • 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

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11) Sr Director Clinical Operations – Full Time (San Francisco or Greater Bay Area) PG166T

DESCRIPTION:

  • Provide oversight of activities for the management of clinical trials globally, ensuring high quality and reliable clinical trial data in a timely fashion. 
  • This position will have a number of direct and indirect reports, including the management of contractors, and will lead or participate in discussions related to resource management, department and staff development initiatives, staff training initiatives and be responsible for management and development of staff. 
  • Ensure appropriate oversight and management of external vendors including CROs, and for timelines, budgets, study quality, and risk management in support of our rare disease programs.  In addition, the incumbent will lead department or cross-functional initiatives and will serve on internal governance committees.   
  • Management, with minimal supervision, of all aspects of clinical trials to ensure GCP and regulatory compliance, quality, and timely completion
  • Supervision and management of internal Clinical Operations, Patient Advocacy and Clinical Training and Education staff
  • Participation in the review of clinical outsourcing strategies and plans
  • Development and management of the assigned clinical trial budgets and resource assignment
  • Responsible for representing clinical operations on cross-functional project teams and vendor/CRO executive meetings and ensuring compliance with global operational standards and procedures
  • Provide leadership for clinical 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 operational guidance for investigators and provide CRO training related to  the study conduct
  • Participate or oversee activities leading to Internal GCP audits and regulatory Inspections related to clinical trial conduct
  • Contribute to the development of global SOPs and policies to ensure compliance with global regulatory requirements and to drive improvements in global processes
  • Interview, select, manage, and train employees
  • Evaluate employees’ efficiency, productivity, and quality of work

EXPERIENCE AND QUALIFICATIONS:

  • A minimum of 12 years of management experience in a clinical research environment
  • Significant hands on experience in early phase and late phase clinical trials
  • Communicates big picture implication and considerations of drug develop strategies to organization and teams
  • Contributes to clinical development planning and document development
  • Coaches and trains others on drug development concepts
  • Extensive experience working in GCP environments on global studies across a range of phases. Experience in regulatory GCP inspections.
  • Demonstrates ability to recognize and manage breaches in GCP.  Takes appropriate steps to remedy or escalate
  • Demonstrated ability to ensure effective and efficient management of clinical research projects
  • Creative problem-solver
  • Expert tactician who can devise plans regarding operational challenges such as site activation, patient enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
  • Experience and willingness to partner with other R&D functions and a customer-service oriented mentality
  • Outstanding verbal and written communication skills, in addition to excellent organizational skills
  • Proven track record as a leader in oncology clinical trials in the biotech or pharmaceutical industry
  • A Bachelor of Science / Masters preferred in a scientific field.

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

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12) Clinical Trial Manager – Contract (Pennsylvania) 4338

DESCRIPTION:

  • Interact at project team and clinical team level to streamline product flow management throughout the product value chain: sourcing, packaging, distribution and reverse logistics.
  • Delivery of key trial supply documentation (including writing, review and approval as per procedures)
  • Label specifications (master labels are in English and get translated by translation department) packaging requirements packaging instructions when local partner involved packaging order issuance
  • Follow-up of quality control and release activities.
  • Follow-up and coordination of shipping clinical logistics activities for timely deliver up to clinical sites.
  • Coordination of reconciliation effort and delivery of global reconciliation report.
  • Quality control of documentation and archival of trial supply documentation in accordance to trial master file requirements.
  • Setup, preparation and facilitation of working sessions with the key participants (trial managers, clinical logistics coordinator, clinical statistician, packaging unit coordinator, quality representatives, shipping unit representative). Weekly progress report to the CSC Project managers in charge.
  • Timely reporting to CSC Project manager of issues that may affect the commitment given to clinical and project teams.
  • Provide assistance for conflict resolution

EXPERIENCE AND QUALIFICATIONS:

  • 3-6 years of experience
  • Thorough understanding of GXP regulations with respect to vaccine label/packaging, distribution, returns, and reconciliation as well as experience with supply chain procedures and clinical trial operations is required. 
  • Excellent ability to interface with a variety of functional areas within the clinical supply chain.  
  • Excellent oral and written communication skills to include presentations in support of training on new procedures. High attention to detail. 
  • Excellent negotiation skills. Strong problem solving skills. 
  • Excellent ability to multitask and prioritize workload within a dynamic, timeline driven, culturally diverse organization; effective time management skills. Exercises calm, sound constructive judgment during high demanding situations. Ability to organize and lead meetings.
  • MS Office solutions (word, excel, powerpoint, Excel, and Outlook)
  • Documentation management systems and Quality management systems
  • Collaborative platforms (sharepoint, eRooms)
  • Past exposure to SAP would be a plus
  • BS Health Science, engineering or related discipline. 
  • At least 5 years' experience in pharmaceutical business required, preferably within supply chain, clinical operations or manufacturing environments.
  • Project management and APICS certifications desired.

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

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13) Pharmacovigilance Writer – Contract (New York) GR177Z

DESCRIPTION:

  • Work under the direction and supervision of the Manager, Pharmacovigilance in supporting the compilation of safety data for the Medical Affairs group.  
  • As produce regulatory documents such as Developmental Safety Update Reports (DSUR), draft Risk Management Plans (RMP) and it is important that these documents be available to withstand regulatory scrutiny and be available for license partners. 
  • Important that to have scientifically valid and consistent documents. 
  • Development & writing of the 1st Risk Management Plan (RMP)
  • Development & writing of the Update to Investigator’s Brochure (IB)
  • Development & writing of the Core IB; 

EXPERIENCE AND QUALIFICATIONS:

  • Minimum 5 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge, plus strong knowledge of medical writing processes
  • Strong experience in medical writing for regulatory and safety submissions
  • Minimum: B.S. in life sciences or equivalent. 
  • Advanced degree desirable.
  • Excellent medical writing, communication, leadership, and presentation skills
  • Expert knowledge and writing of safety reports (i.e. DSURs, PBRERs, RMPs, etc.)
  • Good understanding of statistics
  • Expert knowledge of global safety and regulatory requirements and clinical development

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

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14) Senior Clinical Program Manager, CNS – Full Time (San Francisco or Greater Bay Area) PS174A

DESCRIPTION:

  • Lead and manage clinical trials and oversee all operational aspects including budgets, timelines, resources, vendor selection and management as well as oversight of clinical team staff during study start-up, interium monitoring and closeout periods. 
  • This position is similar in scope to the CPM level with more experience overall in areas such as Phase III trial execution, global trial management and vendor management. This level has significant experience in managing staff. 
  • Reports to a Director or Associate Director in clinical operations. 
  • Leads and manages clinical study teams to ensure that trials are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
  • Leads and manages multiple study teams and associated activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports
  • Provides management oversight and team leadership in the management of study sites and the training of clinical site personnel to ensure protocol and regulatory compliance
  • Responsible for multiple clinical trial clinical site budgets
  • Leads and manages efforts of multiple studies and the oversight of the Contract Research Organizations (CROs) responsible for the conduct of these clinical studies, and including clinical services, data management, bio statistical services, and central laboratory services
  • Lead and manage several levels of clinical personnel, including in-house and contract Clinical Research Associates (CRA)
  • Responsible for ensuring SOP and regulatory compliance of staff on multiple studies.
  • Supports efforts on several studies in the development and writing of study protocols, study plans, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA).
  • Supports communication efforts and interactions with investigators and thought leaders for protocol development, presentations and publications
  • Leads and manages efforts for multiple investigator meetings
  • Mentors and develop junior staff.
  • Leads efforts in the management of clinical supplies needed for the conduct of several clinical trials.
  • Develop clinical monitoring plans and monitor team adherence to these plans in multiple clinical trials.
  • Identification and resolution of administrative issues with investigational sites and/or CROs

EXPERIENCE AND QUALIFICATIONS:

  • Greater than 8 years of relevant clinical operations experience in a CRA functional role in the pharmaceutical industry, Biotech or equivalent.
  • Knowledge of GCP and ICH guidelines required
  • Proficiency in the implementation, monitoring, and management of clinical trials
  • Demonstrated managerial and supervisory skills
  • Excellent communication and interpersonal skills. Detail oriented
  • Able to problem solve and use good judgment
  • Able to work within a team and work with general instructions
  • Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project skills preferred
  • Must be willing to travel (approx. 10%)
  • Bachelor's degree in a relevant scientific discipline or equivalent

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

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15) Director / Associate Director, Document Control, Quality Assurance – Full Time (San Francisco or Greater Bay Area) JM174A

DESCRIPTION:

  • Supports the testing and manufacture of drug substance and drug products (and/or devices) through managing and archiving related documentation 
  • The scope of the position involves quality oversight of all aspects of GxP documents, ownership of the validated electronic document management system, GxP compliance training, support for audit/inspection/due diligence, and documentation related multi-project management. 
  • The essential function of this role is to provide a high level of customer service, continuous process improvement, strategic planning, cross-functional support and guidance, and operational/technical assistance
  • Oversee the management of the electronic controlled document management system (CDMS)
  • Develop metrics and reports to assess the health of CDMS and associated work processes
  • Provide technical support and lead the design and development of life cycles and workflows as required by the various regulatory authorities
  • Provide guidance and oversight of the controlled management of Quality System documentation, including CAPAs, DRs, OSNs, etc.
  • Strategize with quality and cross-departmentally to assess effectiveness of current systems and processes and make recommendations and plans for improvements
  • Oversee the maintenance and organization of an up-to-date file room of required hardcopies (incl. SOPs, training records, reports, protocols, etc.), including managing offsite storage and retrieval
  • Strategize with Quality and cross-departmentally to identify and implement common goals and leverage common processes and systems for archiving, retention, tracking, and retrieval
  • Develop robust GxP training program to ensure employees are qualified to perform duties
  • Ensure employee training records are tracked and maintained appropriately and can be readily accessed during inspections
  • Develop and deliver change control, good documentation practices, quality manual, GMP annual, and CDMS training to all GxP employees, among other training needs identified
  • Develop metrics and reports to assess the health of the continual GxP training program
  • Identify areas of improvement, including evaluating and advocating for an electronic learning management system, and make recommendations
  • Audit company-wide GxP training records regularly
  • Operational project management; prep documentation and applicable work process lead for all inspections, due diligence, and audits 
  • Management of operations, documentation, controlled docs, systems, and training SME during audits and inspections
  • Training and support in the preparation for and during partner due diligence and regulatory agency inspections
  • Strategic contributions before, during, and after inspections, as necessary
  • Develop and implement plans to maintain a constant state of inspection readiness
  • Advise quality VP on budget, resources, equipment, staffing, training, or other departmental needs
  • Serve as the quality operational technical representative on any teams evaluating new documentation processes document Control set-up and implementation, including participating in review of potential candidates, evaluating and implementing document management, training, and trial master file (TMF) management systems
  • Serve as the Quality lead for the clinical operations TMF Management Program to ensure documentation and processes are controlled, standardized, and relevant
  • Develop and guide direct reports, interns, temps and consultants

EXPERIENCE AND QUALIFICATIONS:

  • Electronic document management system implementation experience, including project management, administration, and training
  • Advanced software skills (including Documentum, SharePoint, Visio, Project, Acrobat Pro, LiveLink, Trackwise, and Topyx), and demonstrated troubleshooting and problem-solving techniques
  • Seasoned lead on validation projects
  • Impeccable writing, proofreading, editing, and formatting skills
  • Strategic planning, leadership, and negotiation skills, and the ability to develop and present training materials to large groups; attend conferences as a speaker
  • A Bachelor’s degree, preferably in Business Administration / Management, Computer Science or a Life Science (technical/operations background preferred)
  • A min of 10 years experience in doc control and/or doc management in pharma / biotech. Experience in the medical device industry, a plus
  • A min of 6 years experience as a business administrator of an EDMS. Documentum preferred.
  • Working knowledge of US / EU regulations and guidelines, including 21 CFR Parts 11, 210, 211, 820

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

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16) Director of Quality Assurance – Full Time (North Carolina) XT176B

DESCRIPTION:

  • Responsible for strategy development and execution of quality improvement programs and oversight of the corporate QA auditing function and the GXP training function, which are key contributors to the identification and implementation of these programs. 
  • Participates in the development of the overall corporate quality strategy 
  • Development of a strong quality Improvement program focused on maintaining compliance at all sites and leveraging ideas/best practices identified through the external auditing programs and participation in industry/FDA meetings.  
  • Develop the budget for operations under the responsibility of the role and ensure services are delivered within budget and on time.
  • Develop in participation with the quality leadership team the strategy, projects and programs to ensure quality systems, processes and procedures evolve in a timely manner to address these changes.  
  • Manage the project tasks and deliverables for identified projects.
  • Responsible for oversight, management and leadership of the internal and external auditing programs working with internal customers within the quality organization and supply chain to ensure appropriate prioritization and follow up of identified issues and actions.  Lead extended due diligence activities for the organization to identify issues/investments needed to ensure compliance and allow appropriate valuation of potential assets under consideration for acquisition.
  • Responsible for oversight of the GXP training group and its evolution to effectively and efficiently support regulated training needs for the organization.
  • Lead initiatives to harmonize systems throughout the organization where appropriate.  Ensure risk identification and mitigation tools are used in the assessment of systems, procedures and deviations.
  • Provide project management oversight of integration of new product and company acquisitions to ensure continued acceptable compliance levels.
  • Performs other related assignments and duties as required and assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated thorough knowledge of quality processes and compliance.   
  • Knowledge of GxPs and regulatory requirements (US and international), acquired through education, experience or training. 
  • Proven track record of interactions with FDA and other regulatory agencies.
  • Project management experience including project definition, strategy and negotiation for resources to support implementation. Demonstrated success in team building and development.
  • Demonstrated expertise in process mapping, Lean Manufacturing & Six Sigma techniques for process optimization.
  • Ability to negotiate needed actions and manage difficult interactions effectively
  • Effective written and oral communication skills
  • Minimum BS degree in a scientific discipline plus fifteen years’ pharmaceutical quality assurance/quality control experience, including management experience and budget responsibility.

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

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17) Senior Project Manager, Business Technology Management – Full Time (San Francisco or Greater Bay Area) LQ166C

DESCRIPTION:

  • Responsible for ensuring the success of technology projects within the development sciences organization by effectively managing the scope, schedule and cost as well as effectively communicating and managing stakeholders to attain specific organizational goals.
  • Responsible for the full project lifecycle from creation through project implementation
  • The PM works with internal business functional areas, IT, vendors, consultants, and other identified specialists.
  • Full life-cycle management of BTM technology projects
  • Plans and manages project timelines, deliverables, and milestones, independently, using a structured, disciplined project management approach
  • Works across business functions, as necessary, to determine and define requirements and plan project deployment
  • Defines resources and schedules for projects implementation.
  • Responsible for managing issues, identifying risks, contingency planning and resolving issues, as necessary.
  • Assists in development of documentation deliverables, as applicable.
  • Manages vendor and contractor management as applicable to the project(s)
  • Regular status reporting to management.
  • Adheres to project management office (PMO) standards and processes.

EXPERIENCE AND QUALIFICATIONS:

  • Minimum 12-15 years overall experience within Pharmaceutical/biotech industry
  • 7 years project management experience in regulated/life sciences industry
  • 5 years professional experience with software or technology used on the job, including business application and / or platform implementation. 
  • Strong leadership skills in project definition and delivery
  • Excellent communication and team building skills with an ability to balance, negotiate and work with a variety of internal and external stakeholders to build strategic partnerships.
  • Experience with commercial applications that are used in R&D within the pharmaceutical/biotech industry.
  • Proven experience simultaneously managing and delivering on multiple competing priorities.
  • Expertise managing through ambiguity and finding ways to be productive even when uncertainty is unavoidable.
  • Anticipates and actively manages project risks.
  • Competent at documenting and formalizing business processes.
  • Demonstrated skills in resource organization, project/task prioritization and schedule development.
  • Excellent quantitative and qualitative analysis skills.
  • Understanding of drug development processes.
  • Understanding of computer system validation practices and principles.
  • Experience with Project Management Office (PMO) standards and processes.
  • Knowledge of GxP compliance and impact on technology projects.
  • Strong Presentation Skills
  • Strong collaboration / team building skills
  • Expertise in MS Project and MS Office
  • Certification in Project Management preferred
  • Bachelor's Degree or higher in Computer Science, Technology or related field.

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

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18) Sr. Manager, Clinical Operations, Oncology – Full Time (San Francisco or Greater Bay Area) G166AT

DESCRIPTION:

  • 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.
  • 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 programs

EXPERIENCE AND QUALIFICATIONS:

  • 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
  • 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
  • Bachelor’s required in a scientific/medical field.  
  • Advanced degree preferred.

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

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19) Manager, Clinical Operations – Full Time (San Francisco or Greater Bay Area) PD166N

DESCRIPTION:

  • 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.
  • 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 team 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:

  • Minimum 5 years experience in Clinical Operations: working with CROs and other vendors
  • At least 5 years of management experience in a clinical research environment
  • 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
  • A Bachelor of Science / Masters preferred in a scientific field. 
  • Advanced degree preferred

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

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20) Director Clinical Operations – Full Time (San Francisco or Greater Bay Area) BW175M

DESCRIPTION:

  • Manage daily operations of clinical programs including manage clinical CRO and other outside vendors. 
  • Must have an expert and comprehensive understanding of ICH/GCP requirements, principles, industry best practices, and standards. 
  • Under the direction of the Executive Director of Clinical Operations
  • Responsible for operational leadership and successful execution of clinical trials according to regulatory guidelines. 
  • Responsible for achievement of project goals and objectives on time and on budget. 
  • Must facilitate effective internal and external relationships.
  • Manage CRO and any other clinical trial vendors
  • Provide direction and leadership in CRO and vendor selection and management
  • Negotiate site and vendor budgets; facilitate execution of site and vendor contracts and agreements
  • Maintain and approve clinical monitoring plans and prioritize study monitoring needs
  • Manage clinical research budgets and timelines including manage overall study budgets, conducting monthly earned value analysis, initiate and coordinate periodic site payments with CRO and working with finance to forecast accruals for clinical trial related expenditures
  • Lead development of required SOPs for in-house activities in support of clinical trial activities
  • Contribute to strategic planning to ensure optimized clinical development plans for assigned projects
  • Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures) and trial conduct.
  • Build, manage, and maintain high performing clinical teams

EXPERIENCE AND QUALIFICATIONS:

  • Expertise management of clinical trial operations including managing CROs, central laboratories, and other clinical study vendors.
  • Expertise in the clinical drug development, operations, and strategic planning.
  • Expertise in international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.
  • Global clinical trial experience is highly preferred.
  • Ability to work on and solve complex problems.
  • Ability to prioritize and handle multiple tasks simultaneously.
  • Effective leadership skills managing and mentoring clinical team members and proven ability to foster team productivity and cohesiveness.
  • Hands-on ability to think strategically and tactically
  • Excellent communication skills and experience in a dynamic and growing organization.
  • Some travel required
  • Bachelor’s degree required; minimum of >10 years related experience in the pharmaceutical or biotechnology industry.

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

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21) Manufacturing Site Training & Development Manager – Full Time (San Francisco or Greater Bay Area) F162XB

DESCRIPTION:

  • To identify GMP training and development needs and direct the development, review, implementation and evaluation of cost effective programs designed to improve the overall performance of operations.  
  • Ensure the availability of high quality training and education programs for operations.
  • Ensure all course documentation is complete and accurate and that all instructors are technically competent and prepared to present training in a professional manner.
  • Review course critiques/comments evaluating inputs from various sources in order to incorporate recommendations, revisions, and improvements in a timely manner.
  • Marketing the services of the function.
  • Monitoring and controlling of financial expenses in the training.
  • Establish measurements to assess quality and quantity of developed and delivered training programs.
  • Ensure the on time availability of appropriate training and education programs for all levels in operations.
  • Provide expert consultation to line management on training & development
  • Ensure timely delivery of requested training and education
  • Provide a strategic training plan for all operations departments and levels
  • Provide value added consultative skills on TQM, LEAN, and Six Sigma processes
  • Provide leadership to department members to ensure meeting overall operations goals and individual development goals
  • Provides support to operations in managing the training and education available for all employees.  
  • Provides expert consultation on performance improvement process and initiatives.

EXPERIENCE AND QUALIFICATIONS:

  • Expert knowledge and understanding of GMPs, keeping up to date with current industry issues and changing regulations.  
  • 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.
  • Comprehensive experience of training systems is required. 
  • Demonstrated experience building and managing role-based curricula and instructor qualification programs. 
  • Experience working in an FDA regulated environment. 
  • Requires understanding of GMPs for pharmaceutical manufacturing.
  • Comprehensive experience of training systems is required. 
  • Expertise in curricula development and adult learning is necessary 
  • Exceptional interpersonal, communication and organizational skills along with the ability to prioritize and multi-task. 
  • The ability to be an independent and analytical thinker.
  • 10 years demonstrated business experience focused on people management and development preferred.  
  • 5 years training development and delivery experience (including project management).  
  • Strong process improvement consulting skills and experience are a must.  
  • Leading and implementing a quality management process in a manufacturing environment is a plus.  
  • Knowledge of adult learning and instructional design required.  
  • Good computer skills. 
  • Minimum of Bachelor degree in Business or the Sciences.  
  • Specific education or certification in adult learning and/or quality management is preferred.

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

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22) (Senior) Safety Associate – Full Time (San Francisco or Greater Bay Area) PH174A

DESCRIPTION:

  • Responsible for the review, evaluation and management of adverse event reports, and other clinical trials in accordance with FDA, EMEA, Asian Regulatory Authority, other applicable health authorities and ICH guidelines and regulations. 
  • Act as the primary drug safety representative for assigned study project teams. 
  • Report to the Safety Manager/Director/Senior Director of Drug Safety.
  • Manage safety vendor to ensure timely SAE case entry, processing, notification to business partners, and expedited report submission and tracking.
  • Perform quality check on SAE reports.
  • Perform AE/SAE reconciliations.
  • Coordinate and facilitate the review of SAEs with medical personnel to assure timely assessment of cases.
  • Act as Drug Safety representative for assigned studies and for all safety related activities including participation in the review of study protocols and amendments, case report forms, safety management plans, clinical study reports, ad-hoc safety reports, investigator brochures, annual reports, data management plans, clinical data review plans, data listing reviews, and all other study documents or activities requiring safety review and input.
  • Ensure compliance with local and international reporting of adverse events throughout the program including reporting to competent authorities, ethics committees, and review boards, Investigators, and other manufacturer’s.
  • Facilitate the analysis of similar events and/or risk benefit statement for expedited safety reports occurring in clinical studies.
  • Perform monthly review of SAE data/listings for assigned studies.
  • Support other ongoing safety activities

EXPERIENCE AND QUALIFICATIONS:

  • 2 years of Drug Safety experience for associate level or 4 years for Senior Safety Associate level.
  • Three years recent and relevant experience in drug safety case processing
  • Recent experience using drug safety database (e.g. ARISg or Argus)
  • Recent experience using MedDRA and WHO-DRUG dictionaries
  • Working knowledge of FDA and international pharmacovigilance and clinical safety regulations and guidelines
  • Experience with the content of pharmacovigilance documents such as SOPs, guidelines, safety plans
  • Experience with exchanging international safety data with foreign business partners or affiliates
  • Ability to independently identify problems and effectively offer solutions
  • Excellent written, oral communication, personal organizational skills and resourcefulness
  • Ability to work collaboratively as part of a team in a fast-paced challenging environment
  • Proven proficiency using MS Word, Excel, PowerPoint and Outlook
  • Bachelor’s degree in biological sciences or health care professional (e.g. nurse, pharmacist and etc.), and at least 4 years of Drug Safety experience.

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

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23) Associate Director, Director Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) F166YL

DESCRIPTION:

  • Global Regulatory leader focused on clinical and nonclinical aspects of domestic and international regulatory affairs for late-stage product development in the metabolism and endocrinology therapeutic areas.  
  • Leads an interdisciplinary regulatory team responsible for defining and implementing global regulatory strategy.  
  • Provides regulatory leadership on cross-functional development teams.  
  • Oversees and mentors multiple manager-level and associate-level regulatory professionals to achieve regulatory objectives in line with corporate goals.  
  • Leads interactions with global health authorities and corporate partners.  
  • Continues to expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs and biologics.
  • Lead interdisciplinary regulatory team in establishing global regulatory strategy for late-stage development programs
  • Oversee planning, preparation, and submission of clinical trial applications and marketing applications in the US and internationally
  • Provide strategic regulatory insight to the project team regarding product development
  • Lead interactions with regulatory health authorities
  • Manage and mentor multiple manager-level and associate-level direct reports
  • Communicate with regulatory consultants regarding product development plans
  • Interact with executive leadership team to discuss global regulatory plans

EXPERIENCE AND QUALIFICATIONS:

  • Minimum of 3 years of experience in managing regulatory staff
  • Skilled at gathering supportive information and developing product approval strategies
  • Demonstrated leadership in defining novel approaches to product development and approval
  • Proven track record of managing critical projects as a part of an interdisciplinary team
  • History of achieving regulatory goals in ambiguous and sometimes challenging situations
  • Proven track record of successfully interacting and negotiating with regulatory health authorities
  • Prior experience leading cross-functional teams in the coordination of regulatory submissions and successfully managing projects to deadlines
  • Thorough understanding of global regulatory environment and relevant drug development regulations and guidelines
  • Outstanding interpersonal and communication (written and verbal) skills
  • Effective task planning and coordination abilities
  • History of solving regulatory problems while exhibiting superior judgment and a balanced, realistic understanding of issues
  • Rare disease experience is desirable
  • Prior experience with both biologics and small molecules is desirable
  • US and international experience preferred
  • MD, PharmD, or PhD, preferably in a science related to medicine and minimum of 4 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry with a clinical and nonclinical emphasis, or
  • MS degree with 6+ years of experience described above, or
  • Bachelor's degree with 8+ years of experience described above

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

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24) Sr. Manager, Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) XA166R

DESCRIPTION:

  • Manages the clinical and nonclinical aspects of global regulatory affairs activities in support of late-stage product development.  
  • Provides leadership in the strategy and implementation of regulatory concepts within cross-functional project teams.  
  • Oversees and mentors associate-level regulatory professionals to achieve regulatory objectives in line with corporate goals.  
  • Supports corporate partners with regulatory deliverables.  
  • Continues to expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs and biologics.  
  • Reports to the Global Regulatory leader for assigned product.
  • Manage planning, preparation, and submission of clinical trial applications (CTAs) and marketing applications (MAs) in the US and internationally
  • Manage CTA and MA maintenance activities
  • Provide strategic regulatory insight to cross-functional project teams regarding product development
  • Serve as primary point of contact with regulatory health authorities
  • Manage and mentor multiple associate-level direct reports
  • Exercise discretion and independent judgment in the performance of the duties described above

EXPERIENCE AND QUALIFICATIONS:

  • Minimum of 6 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry with a clinical and nonclinical emphasis
  • Minimum of 3 years of experience in managing regulatory staff
  • Skilled at gathering regulatory information and developing product approval strategies
  • Proven track record of managing critical projects as a part of an interdisciplinary team
  • Proven track record of successfully interacting with regulatory health authorities
  • Prior experience managing regulatory submissions to deadlines
  • Thorough understanding of relevant drug development regulations and guidelines
  • Outstanding interpersonal and communication (written and verbal) skills
  • Effective task planning and coordination abilities
  • Rare disease experience is desirable
  • Prior experience in the metabolism or endocrinology therapeutic areas is desirable
  • BS degree in life sciences required. 
  • Advanced degree preferred.

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

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25) Associate Director, Development Sciences Project Management, Oncology – Full Time (San Francisco or Greater Bay Area) TS166W

DESCRIPTION:

  • Report to the VP of project management for general project management responsibilities,  
  • The primary responsibility will be to provide project management expertise to cross-functional project teams, ensuring that project plans are developed and executed in accordance with corporate goals, and that the utilization of organization, planning, tracking and communication tools and techniques is practiced with high quality.
  • Develop, implement, and monitor a comprehensive project management plan for each assigned study while considering strategic objectives and corporate priorities.
  • Lead clinical study teams throughout the study planning, conduct, data management, and close out phases.
  • Develop and maintain integrated project timelines.
  • Monitor the monthly budgeting process, including forecasting and variance analysis.
  • Achieve high level team performance by ensuring the correct composition of team and functional area expertise is in place and that understanding of objectives, responsibilities, and efficient decision-making is carried out.
  • Ensure that timely and consistent communications regarding project strategy, status, risks and decisions are made within the team and to senior management, the company and partners.
  • Develop and maintain strong, collaborative relationships with key stakeholders and represent the project/sub-projects within development sciences and throughout the broader organization.
  • Play a central role in the development and implementation of new project management processes and policies to advance the growth and effectiveness of the PM function.

EXPERIENCE AND QUALIFICATIONS:

  • 5-10 years experience in a Biotech or Pharmaceutical/CRO organization with a minimum of 5 years in project management or program management in oncology drug/diagnostic development.
  • Extensive knowledge of overall drug development process and roles for the various functional areas within clinical development.
  • Demonstrated excellence in managing multiple oncology clinical projects in different phases (I–IV).
  • Extensive knowledge of Good Clinical Practices and application to the conduct of global clinical studies.
  • Strong financial acumen; capable of planning and oversight of project budgets.
  • Proven personnel management, communication, interpersonal and influence 
  • A Bachelor of Science required.
  • Masters or comparable experience in oncology drug/diagnostic development or the oncology scientific/clinical field preferred.
  • Certification or professional training in project management preferred.

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

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26) Regulatory Operations Specialist – Contract (San Francisco or Greater Bay Area) AT171H

DESCRIPTION:

  • Seeking an experienced regulatory operations specialist who will be responsible for functional activities related to regulatory submissions as well as clinical and compliance documentation.
  • Review, format, and edit documents for regulatory submissions (both US and international filings). 
  • Evaluate documents to ensure accuracy and compliance with internal style guide and applicable regulations.
  • Interact as needed with external consultants, clinical, and other functional areas to prepare and publish regulatory submissions (clinical investigator documentation, annual reports, information amendments).
  • Track and coordinate regulatory submission activities to ensure timelines and commitments are met.
  • Index, scan, and electronically archive paper/electronic documentation for regulatory and clinical files.
  • Troubleshoot technical issues related to formatting documents.
  • Maintain SharePoint sites for development projects including review of the organization, content, and functionality.
  • Assist with implementation of Standard Operating Procedures (SOPs).
  • Format and route SOPs for review and approval, distribute approved SOPs, and maintain SOP training records.
  • Assist development project team leaders with project management activities including issuing agendas and minutes and other activities, as needed.
  • Develop regulatory knowledge and keep abreast of regulatory procedures and changes.

EXPERIENCE AND QUALIFICATIONS:

  • Highly proficient in the use of Word and Adobe Acrobat; proficiency in the use of PowerPoint, Excel, and SharePoint desirable.
  • Experience with electronic submissions and eCTD structure for Investigational New Drug applications (INDs) preferred.
  • Attention to detail, strong interpersonal communication, and excellent writing skills.
  • Ability to work collaboratively with cross-functional teams and be diplomatic, self-assured, and flexible in approach to coworkers and project team members.
  • Well organized and adaptable to shifting priorities.
  • Working knowledge of US regulations and practices pertaining to the development, manufacture, testing, and distribution (GLPs/GMPs/GCPs/) of biological products and electronic submissions.
  • Excellent word processing skills including use of templates.
  • Experience with creating documents for electronic regulatory submission
  • Good understanding of regulatory and compliance documentation.
  • Experience with OmniFile publishing software desirable.
  • BA/BS degree, preferably in the life sciences or technical writing
  • 2–5 years of experience working in a regulated environment and at least 1 year of experience in Regulatory Affairs/Regulatory Operations with a proven track record of success. 

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

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27) SCRA / CTM – Full Time (San Francisco or Greater Bay Area) Q173DR

DESCRIPTION:

  • Support Phase II clinical trials.
  • Reports to the Clinical Program Manager.
  • Participate in the operational planning and execution of clinical trials
  • Work with CRO management to develop work orders and budgets, communicate with prospective partners, and develop study-specific governance plans
  • Take active part in clinical database development and design; help generate clinical database and edit check specifications and participate in user acceptance testing
  • Help develop study specific tools, trackers, operations manuals and plans
  • Participate in the development and management of study budgets and manage specific vendors or cost clinical trial cost categories as directed.
  • Coordinate cross-functional efforts in order to ensure effective team communication and decision-making
  • Participate in infrastructure and process improvement initiatives – take active part in team meetings and contribute proposals and ideas to aid in efficiencies in trial conduct.
  • Assist with the day-to-day management of CROs and sites in the conduct of one or more clinical studies; organize and lead teleconferences with key CRO personnel, facilitates CRO activities and adherence to scope of work and service agreement
  • Support compliance initiatives to mitigate any compliance risks
  • Perform thoughtful review of clinical site documentation including site-specific regulatory documentation, patient consent forms, monitoring reports, study budgets and training documents.
  • Manage discreet tasks required to deliver the clinical study, including input to operations sections of protocol and CRF, trial start-up, conduct and close out activities
  • Participate in cross-functional teams and may lead clinical operation activities in facilitating communication and interaction amongst internal and external team members
  • Ensure that the study team is up-to-date on current program status and priorities and ensures the goals/objectives are aligned with the corporate goals
  • Provide regular status reports and metric updates of studies to senior management
  • Support clinical program manager to identify risks within studies and proactively plans mitigation strategies
  • Assist in negotiating scope of work and contracts with outsourcing vendors; participate in managing vendors, reviewing vendor work product, invoices and accruals
  • Participate in internal/external audits of vendors/sites and assists in delivering corrective actions
  • May participate in departmental or interdepartmental strategic initiatives and process improvements
  • Assist with the writing of clinical documents such as monitoring plans and study management plans, study reports and annual IND reports
  • Assist with the coordination of data review with cross-functional team to support database lock and Clinical Study Report

EXPERIENCE AND QUALIFICATIONS:

  • Has good working knowledge of clinical drug development processes, clinical trial regulations and GCP; clinical data management
  • Flexibility; ability to adapt to changing priorities
  • Strong communication skills (interpersonal, written, verbal, listening)
  • Effective time management (timelines, schedules, task prioritization)
  • Works with a sense of urgency and prioritizes tasks in order to move multiple projects forward in parallel
  • Displays a high level of commitment, motivation, integrity and professionalism
  • Ability to travel domestically and internationally (up to 30%)
  • Must have a Bachelor’s degree in health sciences field or equivalent and 3-5 years in clinical operations for the pharmaceutical, biotech, or medical device industry

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

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28) Sr. Clinical Operations Associate / SCRA – Full Time (San Francisco or Greater Bay Area) XA173P

DESCRIPTION:

  • Responsible for the establishment and maintenance of systems, processes and procedures to ensure the proper collection, maintenance and archive of essential clinical trial documentation. 
  • Act as a key contact for internal personnel and for clinical site and CRO personnel in matters related to management of essential clinical documentation and will also provide other critical trial support tasks to ensure the reliable documentation of adherence to GCP, SOPs, and applicable regulatory guidance.
  • Support trial management personnel and site monitors by pro-actively managing the collection, maintenance and archive of essential trial documentation.
  • Establish and/or improve upon existing procedures to allow for efficient collection and review of clinical site regulatory packages and investigational product shipment authorization.
  • Develop and prepare indexes, tables of contents, databases and tracking mechanisms to aid in the collection and reliable maintenance of essential documentation and that enable identification of missing or outdated documents.
  • Serve as primary point of contact for clinical sites, CROs and other external parties in matters directly related to essential trial documentation.
  • Partner with senior-level managers and quality assurance personnel to prepare for and facilitate clinical master file inspections and audits as directed and to ensure appropriate resolution and completion of corrective actions as directed.
  • Provide clinical trial support activities as directed. These activities will vary and may include the preparation and shipment of site regulatory binders, preparation, shipment and tracking of non-investigational trial supplies, monitoring report tracking and follow-up, DCF tracking, SAE follow-up, preparation of materials for site initiation or close-out visits, development and maintenance of monitoring tools or templates and logs, maintenance of tracking databases, first level review of trial-related invoices, and other activities as directed.
  • Coordinate supplies and prepare materials for storage and shipping

EXPERIENCE AND QUALIFICATIONS:

  • Candidates with 5+ years of experience directly related to clinical trial documentation may be eligible without a four-year degree
  • Experienced clinical research personnel only
  • Demonstrated knowledge of US clinical research regulatory requirements as described in ICH GCP Section 8, FDA 21 CFR and other applicable sources.
  • Previous experience and success in a role that involves the critical review and ongoing maintenance of essential clinical trial documentation
  • Highly competent computer proficiency and familiarity with Microsoft Office (Word, Excel, and PowerPoint).
  • Strong written and verbal communication skills
  • Strong interpersonal skills
  • Ability to establish and maintain positive working relationships with managers, peers and multiple outside partners
  • Positive approach to work, self-motivated and able to take initiative on projects
  • Must be a master of organization with a keen attention to detail and ability to juggle multiple priorities
  • International clinical trial documentation experience or regulatory inspection experience highly desirable.
  • May involve occasional travel (up to 15%)
  • Bachelor’s or RN degree plus 3 or more years in the pharmaceutical/ biotech industry (or equivalent academic clinical research role) with at least 2 years directly related to clinical trial conduct and essential trial documentation.

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

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29) Sr. Clinical Project Coordinator – Contract (San Francisco or Greater Bay Area) RE171B

DESCRIPTION:

  • Seeking a motivated and ambitious project coordinator to provide project management support to cross-functional development teams. 
  • Report into Project Team leadership.
  • Working with program, subteam and functional leaders, provide detailed planning, tracking, and execution support across all aspects development programs.
  • Track program progress relative to approved activities and budget.
  • Experience in establishing and managing external vendor relationships.
  • Coordinate development team meetings, agendas, minutes, and resources.
  • Assist in managing project communication tools and archives in order to provide up-to-date project information and documentation to team and functional management.
  • Assist in daily operational management of project activities to ensure execution upon team deliverables.
  • Facilitate cross-functional coordination, communication, and teamwork across the development program.
  • Responsible for migrating existing date into SharePoint

EXPERIENCE AND QUALIFICATIONS:

  • At least 2 years of experience in project management
  • Solid understanding of clinical and nonclinical drug development is required; oncology program experience a plus
  • Experience in using project management tools such as Microsoft Project, Excel, and Sharepoint
  • Excellent communication and interpersonal skills, time/resource management, attention to detail, and proven success working in matrix environments
  • Ability to handle complexity, prioritize and multitask concurrent project demands
  • Excellent analytical and organizational skills (resources, timelines)
  • Qualified candidates should possess a field relevant BS, MS, PhD, or MBA

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

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30) Scientist I, II – Pharmacology/Tumor Immunology – Full Time (San Francisco or Greater Bay Area) AC171B

DESCRIPTION:

  • Seeking a talented in vivo pharmacology scientist with an emphasis in tumor immunology to guide discovery and development of novel protein therapeutics to treat cancer using drug discovery platforms.  
  • This individual will apply understanding of the pathogenesis of oncology to guide innovative drug discovery strategies, steer and help lead emerging portfolio of novel products, and provide input and support in the preclinical and early clinical development of these new therapies.  
  • Responsible for hands-on studies with in vivo models of disease, and it is expected they will already have significant training and skill with in vivo models and their relevance to human disease.   
  • Will be part of a team that interacts with pharmaceutical partners and academic collaborators within these disease areas.  
  • Report to the Executive Director of Pharmacology, and will contribute to programs and projects across a matrixed environment.

EXPERIENCE AND QUALIFICATIONS:

  • Must have expertise in tumor immunology.
  • Must have hands on experience with in vivo models of oncology including subcutaneous and orthotopic xenografts, syngeneic and leukemia models. 
  • Experience with flow cytometry is highly desirable.   
  • Demonstrated experience with characterization of immune cell populations in tumors by FACS is highly desirable.
  • Must have strong written and verbal communication skills, with the ability to clearly articulate complex concepts and strategies.
  • Must have demonstrated leadership and critical thinking skills.
  • Experience in collaborations and/or alliances are strongly desired.
  • Expertise in drug discovery and development with protein-based therapeutics including monoclonal antibodies is highly desired.
  • Experience with translational biology and/or early development of drug discovery programs is strongly desired.
  • Applicants must have a Ph.D. and at least 2 years of post-graduate experience in tumor immunology disease research.  
  • The ideal candidate will be competent with multiple in vivo models of oncology including subcutaneous and orthotopic xenografts, syngeneic, and leukemia models, and will be an outstanding scientist with notable publications and achievements within tumor immunology. Have the ability to independently design, conduct, interpret, and communicate results related to in vivo studies aimed at validating clinical leads in our pipeline. 
  • The ideal candidate will also have some direct experience working with the pharmaceutical or biotechnology industry.  

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

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31) Director, Bioanalytical Development – Full Time (San Francisco or Greater Bay Area) M171JL

DESCRIPTION:

  • Report to the Vice President of Preclinical Development within the development organization and will lead a working group consisting of PhD level scientists and research associates that focuses on the development of bioanalytical methods supporting pipeline of preclinical and clinical therapeutics antibodies
  • Responsible for the oversight of a group of scientists that develop robust assays that measure the pharmacokinetics, and anti-drug antibodies preclinical and clinical candidates.  The Bioanalytical Development group is part of a matrixed organization that serves both research and discovery as well as later stage development programs.  The group develops assays that serve internal research purposes and are subsequently transferred to GLP and/or clinical laboratories for validation and clinical sample testing.  Familiarity with GLP requirements is essential for this role.  
  • Develop tests for specific analytes and biomarkers to interrogate the biology of the pathways being targeted. 
  • Selection, management and oversight of outsourced CRO activities
  • Keeping current and tracking changing trends in the regulatory requirements for bioanalysis as pertains to protein based therapeutics and monoclonal antibodies
  • Authoring appropriate sections of regulatory documents (INDs, CTA, BLAs)
  • Representing the bioanalytical functions on multiple project teams and to senior management
  • Setting and meeting department goals that meet or exceed corporate goals

EXPERIENCE AND QUALIFICATIONS:

  • 10 years working in a biotech lab setting
  • Two key assets for this position are the ability to develop, troubleshoot and transfer the following assay type:
  • ELISA-based assays to detect monoclonal antibodies and other protein-based therapeutics in different matrices
  • Meso-Scale Detection (MSD) technology to detect anti-drug antibodies
  • Applicant must have expert knowledge and experience of both these assay formats.
  • Proven experience working and leading a bioanalytical laboratory environment is essential
  • Prior managerial experience including leading a team of PhD level scientists and analysts
  • Management and oversight of bioanalytical activities at third party contract research organizations including interface for assay transfer, validation and sample handling
  • First hand-experience in designing, developing and troubleshooting methods for pharmacokinetic and anti-drug antibodies that are suitable for use in GLP and clinical studies
  • Track record of success as demonstrated by successful regulatory submissions (e.g., IND CTA, BLA), peer-reviewed publications and/or presentation at industry meetings is required
  • Strong inter-personal skills
  • Excellent written and oral communication skills
  • Ability to lead and work with others in a positive and collaborative manner
  • PhD in biochemistry, chemistry, immunology or related science, as appropriate

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

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32) (Senior) Director Oncology Companion Diagnostics – Full Time (San Francisco or Greater Bay Area) TH171Q

DESCRIPTION:

  • Oversee the clinical development of biomarkers and companion diagnostics.  
  • Work closely with the translational medicine team and other groups to assure a successful implementation of biomarker and patient selection strategies into  pipeline of protein based therapeutics. 
  • Report to the VP of Preclinical Development in the development organization.
  • Provide the vision and leadership to build the integration of biomarkers and diagnostics into clinical pipeline.
  • Interface with the Translational Medicine, Bioanalytical development and clinical groups to identify strategies for the development of clinical biomarkers that demonstrate pharmacodynamic responses and patient selection markers
  • Ensure effective cross-functional interactions  between the different functional groups as relates to biomarker and diagnostic discovery and development
  • Work with the translational medicine group to integrate  prognostic and response markers into the clinical development programs to ensure state of the art thinking on appropriate biomarker technologies, recognizing the scientific and clinical basis, of the proposed biomarkers 
  • Participate as a key member of multi-disciplinary project teams and lead all areas of clinical biomarker as well as companion diagnostic (CDx) development.
  • Identify and liaise with key opinion leaders in the area of clinical biomarkers and companion diagnostic development to guide the project team to select and utilize appropriate biomarker strategies. Plan and implement sample acquisition and analysis in clinical studies. 
  • Follow scientific trends in the area of biomarkers and their utilization as response markers and companion diagnostics as applied to targeted therapies directed in the fields of oncology, inflammation and immune-oncology.
  • Lead CDx partner evaluation and selection activities and subsequently oversee implementation of activities at external CROs performing validation and diagnostic assay runs.
  • Interface with regulatory agencies to develop strategy for biomarkers and diagnostics.
  • Generate reports summarizing study findings and contribute to clinical documents such as protocols, investigator brochures and key regulatory documents for the submission and approval of companion diagnostics.

EXPERIENCE AND QUALIFICATIONS:


  • Participation in, leadership and management of matrixed project teams to deliver results
  • Publications or relevant papers in peer review journals or presentation at meetings
  • Filing regulatory documents with agencies to support the use and adoption of biomarkers as response markers and/or companion diagnostics
  • Must have a MD or PhD in an appropriate discipline
  • Minimum of 10 years of relevant experience working in the area of drug development
  • Prior experience working in the field of translational medicine and/or companion diagnostics is essential for this position.

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

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33) Senior Scientist/Scientist III - Immuno-Oncology – Full Time (San Francisco or Greater Bay Area) K171BN

DESCRIPTION:

  • Expert in the field of cancer immunology and will be in charge of identifying and validating novel cancer immune therapeutics. 
  • Will lead projects and be responsible for progressing therapeutic candidates from discovery to IND-enabling studies. 
  • Will be expected to identify new cancer immunotherapy targets and to implement program strategies with clear go/no go decision points and objective timelines.  
  • The ideal candidate will have significant experience leading projects preferentially in an industry setting. 
  • The candidate will have an extensive background in immunology with particular emphasis on Thymus cell and cancer; extensive knowledge of effector and/or regulatory Thymus cell is expected. 
  • Demonstrated leadership and team working skills are key attributes to this position. 
  • The candidate will present project updates to Sr. Management and other audiences.

EXPERIENCE AND QUALIFICATIONS:

  • The applicant should have significant experience leading project and working with cross-functional teams. 
  • Will be an outstanding scientist with a track record of high impact publications and presentations in the field of immunology or cancer immunity. 
  • Outstanding communication and presentation skills.
  • Expertise in immunology or cancer immunology is required
  • Expertise on Thymus cell biology preferentially effector and/or Regulatory Thymus cells is required
  • Significant expertise in vitro screening and validation assays in cancer immunotherapy is required; in vivo expertise with tumor xenograft and murine syngeneic tumor models would be desirable
  • Experience in drug development and leading teams from discovery to IND  is strongly preferred
  • The ability to lead teams in a cross-functional work environment is critical; strong leadership skills and independence  skills are expected
  • Responsible for setting high standards for experimental research and target validation
  • Expected to have outstanding communication (oral and written) and to be able to present to a wide variety of audiences
  • He/she will enjoy working as a member of a fast-paced multidisciplinary team in an entrepreneurial environment.
  • Applicants must have a Ph.D. in immunology, cancer immunology, or related field with at least 7-10 years of overall experience, (may include post-doctoral experience).  
  • Have at least 4-5 years of biopharmaceutical industry experience in drug discovery in the fields of immunology and/or cancer immunotherapy.

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

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34) Director, Antibody Engineering – Full Time (San Francisco or Greater Bay Area) BA171X

DESCRIPTION:

  • Responsible for antibody discovery and engineering activities.  
  • Lead a team of scientists and coordinate external antibody collaborators and partners to deliver high quality 
  • Responsible for scouting and implementing next-generation technologies to enable multi-specific target neutralization, immune redirection, or tissue-specific targeting.
  • Oversee and coordinate internal and external antibody discovery efforts
  • Support multiple aspects of antibody generation and characterization including assay development, antibody screening and optimization, and antibody engineering
  • Ensure timely delivery of antibody reagents and tools to enable target validation
  • Actively participate, advise, and present on project teams and at leadership team meetings

EXPERIENCE AND QUALIFICATIONS:

  • Technical proficiency in antibody display (phage or mammalian cell), hybridoma technology, and antibody engineering is required
  • Experience with bi-specific antibodies, immune redirection, and/or enhanced effector functions (Antibody-Dependent Cell-Mediated Cytotoxicity and Antibody Drug Conjugates technologies) is desired
  • Highly collaborative with the ability to succeed in a matrixed and dynamic work environment
  • Strong interpersonal, presentation, and communication skills; able to work effectively across the company and with external partners
  • Applicants must have a Ph.D. with 10+ years of antibody discovery and engineering.  
  • The ideal candidate will have a track record of delivering innovative antibody-based medicines into the clinic.

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

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35) Senior Administrative Assistant – Clinical Development & Regulatory – Full Time (San Francisco or Greater Bay Area) Z171GL

DESCRIPTION:

  • Support Vice Presidents of Clinical Development and Regulatory 
  • Provide complete administrative support for the team including but not limited to calendaring, complex travel arrangements (international and domestic), coordination of meetings, facilitating timely responses to action items and other projects as assigned.
  • Partner with other administrative staff members in a professional and team-oriented approach, working together to provide back-up administrative support for other members of the executive team. 
  • Complete a broad variety of administrative tasks in a fast-paced environment
  • Manage the department’s schedules, meetings and office time in accordance with quickly changing priorities
  • Interface with the other administrative team members to facilitate meetings and provide total meeting support
  • Working with legal, coordinate the approval and execution of contracts, non-disclosure agreements and other documents
  • Coordinate attendance, including travel, at external events, conferences and seminars both domestic and international
  • Other administrative duties as assigned 

EXPERIENCE AND QUALIFICATIONS:

  • Must be tech-savvy and possess excellent interpersonal, written and verbal communication skills
  • Strong decision-making skills
  • Ability to think creatively and make sound independent judgments while maintaining a high level of discretion and confidentiality. 
  • Experience supporting a senior executive
  • Superb attention to detail with outstanding follow up required
  • Strong project management skills
  • Strong computer skills with good working knowledge of Word, Excel, PowerPoint, Adobe Acrobat; excellent Outlook skills a must
  • Must be professional, resourceful, assertive, energetic, self-motivated and a proven team player
  • Ability to multi-task in a fast-paced dynamic environment while demonstrating a resourceful, positive attitude and a superior work ethic
  • 8 or more years of experience as an administrative assistant in a team environment
  • Bachelor’s degree required

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

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36) Clinical Program Manager, Clinical Operations – Full Time (San Francisco or Greater Bay Area) WE170Y

DESCRIPTION:

  • Responsible for developing, managing and implementing single and multi-site clinical studies. 
  • Reports to the Senior Director, Clinical Operations.
  • Represent clinical operations as a member of trial teams
  • Develop study timelines, milestones and budgets in collaboration with trial team members
  • Develop study protocols with guidance from medical monitor
  • Develop case report forms, informed consent forms and other study-related documents
  • Selection and qualification of investigational sites
  • Participate in selection of, management and oversight of CROs and other vendors to ensure that clinical studies are executed properly, on time and in compliance with GCPs
  • Review and approve vendor and site invoices
  • Manage external resources, as required
  • Conducts site evaluations/initiation/monitoring and closeout visits, as required
  • Contributes to Clinical Study Reports, NDAs, and other clinical/regulatory/safety documents.– ensuring reports are controlled for quality, signed off and published with copies going to Regulatory Authorities and Ethics Committees, as required
  • Collect and archive documents for inclusion in the Trial Master File

EXPERIENCE AND QUALIFICATIONS:

  • Strong written and verbal communication, interpersonal, problem solving and negotiation skills
  • Good presentation skills: ability to present to diverse groups of clinical staff,  internal and external
  • Proven organizational skills; ability to manage multiple priorities and work under pressure
  • Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials, specifically, knowledge of 21 Code of Federal Regulations Title 21 Parts 11, 50, 54, 56, 312, 314;  ICH, GCP and other guidelines from Regulatory Authorities pertinent to planned studies
  • Computer software: Microsoft Word, Excel, PowerPoint, Project, and Visio
  • Ability to travel
  • 5 – 7 years experience (CRO or pharmaceutical company), with a minimum 2 years experience managing external vendors. 
  • Thorough knowledge of planning, implementing, and managing single and multi-center clinical trials is required. 
  • CNS experience is preferred and international study experience is a plus.
  • Minimum of a BS degree in a relevant scientific discipline

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

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37) Senior Clinical Research Associate – Contract (San Francisco or Greater Bay Area) H170TP

DESCRIPTION:

  • Responsible for ensuring high quality execution of single and multi-site clinical studies according to the protocols, while adhering to GCP, and to SOPs within reasonable limits of time and budget reports.  
  • Reports to the Senior Director Clinical Operations.
  • Identify and qualify potential investigational sites
  • Coordinate and perform comprehensive site management
  • Conduct pre-study selection,  site initiation, interim and close out monitoring visits
  • Assist trial team in drafting study related plans
  • Submit comprehensive visit reports and status reports in a timely manner
  • Resolve and/or escalate logistical, data and audit issues
  • Adhere to the study timelines and budget, in line with managers’ expectations
  • Collect and review trial essential documents and prepare documents for  ethics committee and/or regulatory submissions and supervise filing or assist in filing of essential documents
  • Prepare materials for presentation at investigator meetings or site initiations and other project-related forums

EXPERIENCE AND QUALIFICATIONS:

  • Fluent in the English language and local languages as required for the performance of source data verification and communications
  • Strong written and verbal communication
  • Knowledge of ICH-GCP and applicable local and international regulatory guidelines preferred
  • Demonstrated knowledge of clinical monitoring, follow company SOPs and applicable regulatory requirements
  • Attention to detail and a methodical and systematic approach to work
  • Strong interpersonal skills and an ability to communicate at all levels
  • A proven ability to organize, take initiative and follow-up independently
  • Knowledge of computer software: Microsoft Word, Excel, PowerPoint, Project, Visio, Outlook; SharePoint preferred
  • Ability to travel
  • Five to seven years of clinical research experience
  • Life Science degree or equivalent or Registered Nurse

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

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38) Program Manager – Contract or FTE (San Diego) or Contract (San Francisco Bay Area) M167GB

DESCRIPTION:

  • Responsible for managing cross-functional teams and day-to-day operations in drug development programs.
  • Accountable for keeping program timelines intact, managing support resources; budget planning, scoping, resource planning, and keeping projects on schedule and within budget.
  • Programs range from pre-clinical to pre-launch and cover multiple therapeutic areas.
  • Build strong bonds with functional program leadership and act as a liaison and key advisor to the project team
  • Define tasks, milestones, budget and reporting tools
  • Develop project estimates and plans to manage execution
  • Lead activities to ensure completion of all project milestones and maintain documentation to ensure complete understanding among stakeholders.
  • Critically analyze project milestones, trends and completion dates in order to manage risks, assess gaps/opportunities, and contribute to creation and implementation of action plans to mitigate risks.
  • Work with functional leadership to communicate operational and financial plans
  • Maintain detailed timelines, and project plans for programs
  • Hold project team members accountable to on-time completion and quality of project deliverables and milestones.
  • Manage day-to-day activities of project teams; proactively identifying and resolving issues that would present a risk to on-time implementation of the program.
  • Facilitate day-to-day coordination and communication 
  • Act as a liaison between the assigned project resources, project delivery owner, and key stakeholders
  • Ensure project closure including completion of lessons learned and required documentation
  • Apply knowledge of standards in project management to ensure successful delivery of the project
  • Monitor and report program status to head of program management on a weekly basis using MS Project or other software solution

EXPERIENCE AND QUALIFICATIONS:

  • Healthcare experience that includes managing cross-functional and/or multi-disciplinary teams
  • Experience with drug development (pre-clinical though Phase 1 experience)
  • Experience managing diverse working groups
  • Strong written and verbal communication skills
  • Refined organization and planning skills
  • Ability to self-start and be versatile in a dynamic environment
  • Ability to travel up to 25-50%
  • Willingness to learn additional functional areas
  • Five to Seven years of project management or related experience
  • Bachelor’s degree in business, a life sciences discipline, or related field

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

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39) Associate Project Manager – Contract or FTE (San Diego) or Contract (San Francisco Bay Area) PB167X

DESCRIPTION:

  • Responsible for managing cross-functional teams and day-to-day operations in drug development programs.
  • Accountable for keeping program timelines intact, managing support resources; budget planning, scoping, resource planning, and keeping projects on schedule and within budget.
  • Programs range from pre-clinical to pre-launch and cover multiple therapeutic areas.
  • Build strong bonds with functional program leadership and act as a liaison and key advisor to the project team
  • Define tasks, milestones, budget and reporting tools
  • Develop project estimates and plans to manage execution
  • Lead activities to ensure completion of all project milestones and maintain documentation to ensure complete understanding among stakeholders.
  • Critically analyze project milestones, trends and completion dates in order to manage risks, assess gaps/opportunities, and contribute to creation and implementation of action plans to mitigate risks.
  • Work with functional leadership to communicate operational and financial plans
  • Maintain detailed timelines, and project plans for programs
  • Hold project team members accountable to on-time completion and quality of project deliverables and milestones.
  • Manage day-to-day activities of project teams; proactively identifying and resolving issues that would present a risk to on-time implementation of the program.
  • Facilitate day-to-day coordination and communication 
  • Act as a liaison between the assigned project resources, project delivery owner, and key stakeholders
  • Ensure project closure including completion of lessons learned and required documentation
  • Apply knowledge of standards in project management to ensure successful delivery of the project
  • Monitor and report program status to head of program management on a weekly basis using MS Project or other software solution

EXPERIENCE AND QUALIFICATIONS:

  • Healthcare experience that includes managing cross-functional and/or multi-disciplinary teams
  • Experience with drug development (pre-clinical though Phase 1 experience)
  • Experience with clinical trials preferred
  • Experience managing diverse working groups
  • Strong written and verbal communication skills
  • Refined organization and planning skills
  • Ability to self-start and be versatile in a dynamic environment
  • Willingness to learn additional functional areas
  • Ability to travel up to 25-50%
  • Two to five years of project management or related experience
  • Bachelor’s degree in business, a life sciences discipline, or related field

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

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40) Executive Director, Clinical Operations – Full Time (San Francisco or Greater Bay Area) G166WA

DESCRIPTION:

  • Management of all aspects of clinical trials for rare disease indications ensuring GCP and regulatory compliance, high study quality, and timely completion
  • Represent clinical operations on cross-functional project teams and/or CRO senior oversight committees
  • Provide high level clinical operations input on Clinical Development plans
  • Contribute to strategic planning and evaluation of new programs by supporting timeline development, financial modeling and providing clinical operations input, options and recommendations
  • Mentor and coach members on study and project teams
  • Review all presentations to study and project teams and brief Clinical Operations Function Head prior to any presentations to governance bodies
  • Develop and track metrics and key performance indicators related to clinical trial execution.
  • Implement appropriate actions when indicated.
  • Develop appropriate dashboards to give an accurate status of the various projects.
  • Provide leadership for Clinical Operations related issues and advise development sciences senior leadership team of potential issues and proposed solutions
  • Lead or participate in discussions related to resource management, department and staff development initiatives, staff training initiatives and be responsible for management and development of staff
  • Establish and maintain regular communication with, and solicit feedback from, relevant clinical operations matrix manager(s) and other cross functional team members on each direct report
  • Write and review individual employee plans (including training requirements), performance reviews and promotion documentation
  • Coach staff with management responsibilities to hold performance reviews and develop their staff
  • Conflict resolution, including escalation
  • Lead or provide oversight of sub-teams such as clinical training and Education, resourcing, quality, processes, SOPs or other initiatives
  • Manage all elements of the infrastructure area from planning, resourcing, implementation and continuous improvement
  • Participate or manage activities leading to internal GCP audits and regulatory inspections related to clinical trial conduct

EXPERIENCE AND QUALIFICATIONS:

  • The ideal candidate will possess 15 or more years of pharmaceutical clinical development experience, including extensive history of managing a clinical operations or clinical development group, including proven track record of successfully managing multiple management-level reports and delivering full- service projects on time, within budget and with the required quality standards in order to meet corporate and program deliverables. 
  • Significant hands on experience in clinical trials with complex indications, including but not limited to genetic disorders, orphan indications, first in class drugs, pediatric trials, oncology trials. 
  • Extensive experience working in GCP environments on global studies across a range of phases.
  • Exceptional ability to build and maintain strong working relationships in departmental and cross-functional efforts of multiple individuals, work groups or teams to accomplish a project or corporate goal.
  • Outstanding verbal and written communication skills, can communicate strategic direction and relevant context in such a way that employees, at all levels, fully understand their role in achieving success.
  • Ability to motivate the department and teams to appropriately modify priorities, consider alternatives, and respond quickly and decisively to unexpected and rapidly changing conditions.
  • Experience in generating new ideas that have a significant impact in the workplace by creating new/improved service, being more cost effective and providing better value to clinical development as well as patients.
  • Ability to engage key stakeholders in solution development, understands impact and recognizes other applications of solution. 
  • Encourage and coach teams and functional area to leverage pattern and trend data and think critically, about new approaches and better solutions.
  • Bachelor’s degree in a scientific discipline or equivalent is required / Advance degree preferred.

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

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41) Manager, Process Engineering – Full Time (San Francisco or Greater Bay Area) A146FV

DESCRIPTION:

  • Leads the development and implementation of automation systems and workflows to support the processing of samples in a clinical diagnostics laboratory environment.  
  • Collaborates within a team of scientists and engineers upon projects to conceptualize, design, develop, and implement solutions designed to optimize the performance and increase the efficiencies of the laboratory processes.
  • Leading engineering and automation team
  • Providing projects leadership and direction, building rapport with end-users, lab supervisors and process owners, and coordinating with cross functional projects teams.  
  • Supervise and lead the automation team on the development and integration of automation solutions
  • Defining and leading systems testing and qualification efforts. 
  • Guide and support the documentation for equipment validation and operating procedures, and ensure successful  implementation in the labs.
  • Additional responsibilities include user training, troubleshooting, optimizing the workflows, and on-going support for the end-users.

EXPERIENCE AND QUALIFICATIONS:

  • Strong project management skills, organizational skills, and written and verbal communication skills are required. 
  • Direct Management experience required 
  • Flexibility and self-initiative required to support several simultaneous projects.
  • Ability to collaborate is required.  
  • Preparing user requirement and testing procedure, Standard Operating Procedures, and related documentations; and overseeing the functional and validation testing, IQ/OQ/PQ.  
  • Biotech, pharmaceutical, lab automation providers, or clinical-laboratory experience is highly desirable.
  • A BS or MS degree in a related scientific or engineering field such as Molecular Biology, Process/Industrial Engineering, and Bio-Medical Engineering, with a minimum of eight to ten years of relevant experience.  
  • Technical proficiency and experience in automation systems development and integration for the life science industry; especially with robotics and liquid handling systems is required.  

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

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42) Director/VP Regulatory Consultant – Contract (San Francisco or Greater Bay Area) GP164X

DESCRIPTION:

  • Support and help lead regulatory affairs activities
  • Support  global clinical trials applications

EXPERIENCE AND QUALIFICATIONS:

  • Deep understanding of FDA and rest of world regulations
  • Experience at a start-up company
  • Highly experienced and can work independently
  • Minimum previous title of Associate Director Regulatory Affairs in a pharmaceutical or biotechnology company
  • Higher level preferred
  • On-site work at least 2 days per week
  • Minimum education at the Bachelors degree level

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

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43) CRA II / SCRA – Contract 20 hr per wk (San Francisco or Greater Bay Area) P163AL

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
  • 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

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44) Staff Program Engineer (Validation/Compliance) – Full Time (San Francisco or Greater Bay Area) A162FT

DESCRIPTION:

  • Responsible for ensuring the implementation of compliant, cost-effective, and safe engineering solutions, along with effective change control, commissioning, and qualification practices. Includes evaluating new and existing utility and facility systems and equipment, ensuring they are designed, constructed, installed, commissioned, qualified, and maintained according to Good Engineering Practices (GEP) and local building, fire, safety, and environmental regulations. 
  • Leads cross-functional teams in commissioning, qualification, evaluation, change control, and re-qualification initiatives
  • Manage and coordinate the engineering safety and compliance program, including actions tracking and issues resolution
  • Drive compliance initiatives with a solid knowledge of CalOSHA, CCR, CBC, CMC, CPC, NFPA, NECA, ASME, and NEC applicable requirements, along with the ability to understand and advise site specific CSI specifications, machine design specifications, and design drawings including P&IDs
  • Lead compliance with global engineering initiatives, policies, and guidance; developing gap assessments, remediation plans, action tracking and resolutions.
  • Participate and contribute to the technical compliance and HSE by design global teams and forums.
  • Coordinate HSE by Design, Risk Portfolio, business continuity, and emergency management activities, updates, actions tracking, and follow up
  • Author local Standard Operating Procedures, work practices, or guidance documents to ensure compliance with company policies and applicable regulations
  • Support regulatory submissions and regulatory agency or internal inspections
  • Coordinate engineering audits and FM Global inspections, and manage tracking and closure of observations and recommendations
  • Support investigations, deviations, and Corrective Actions/Preventative Actions (CAPAs), as assigned
  • Manage department led Asset Change Control and re-qualification activities, facilitating all pre and post approval cycles and out of service notice processing
  • Develop and maintain accurate engineering compliance metrics and KPIs
  • Participate in QA compliance forums
  • Maximize an efficient approach to project execution by eliminating redundancy and low value activities
  • Prepare commissioning and qualification plans, high level risk assessments, and quality needs assessments at the outset of all capital projects
  • Advise and support project managers to reconcile deficiencies
  • Perform or ensure the role of design coordinator is fulfilled on all capital projects as defined by the HSE by Design program roles and responsibilities
  • Lead, coordinate, or support high performing teams in the development of system lifecycle documentation, commissioning and qualification documentation, execution, authorizations, and approvals, as required
  • Develop and/or support commissioning and qualification scope definition and cost estimating, along with bid evaluations and contractor selection process
  • Perform audits of contractor and vendors ensuring pre-qualification criteria, as required

EXPERIENCE AND QUALIFICATIONS:

  • Requires a minimum of 10 years industry work experience and 8 years of experience in a GMP pharmaceutical manufacturing environment or other minimum of 3 years of experience in a position where expertise and experience have had a distinct influence on team and/or company decisions
  • Possess in-depth knowledge of GMP and safety regulations related to facilities and equipment, including commissioning and qualification of utilities, manufacturing, and laboratory equipment
  • Ability to manage, organize and troubleshoot complex technical problems
  • Strong oral and written communication skills with excellent technical writing abilities
  • Results-oriented with ability to adapt to changing priorities
  • Must possess sound technical judgment and use structured decision-making techniques
  • Must have an ability to provide technical support in a team-oriented environment
  • Requires a Bachelors degree in an engineering or related discipline

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

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45) (Sr) Director, Financial Planning & Analysis – Full Time (San Francisco or Greater Bay Area) A133FT

DESCRIPTION:

  • Responsible for managing, preparing and administering the forecasting and budgeting process and the associated analysis and presentation, internal reporting, including project reporting and analysis. 
  • Works closely with department managers and ensures the accurate and timely interface of the approved budget or forecast with the company’s purchasing requisition system. 
  • Supports the preparation and review of monthly financials for our partnered programs. 
  • Responsible preparing ahoc analysis for management as required. Also is the finance team member on the company’s strategic planning team.
  • Responsible for the hands-on coordination, and preparation of the company’s annual budgeting and periodic forecasting process and analysis as well as the preparation of the Board presentations
  • On a monthly basis, analyze preliminary financial statements for Director of Accounting to ensure proper project and expense coding
  • Monthly prepare project reports for the company’s collaboration arrangements and review with Senior Management
  • Preparation and distribution of monthly internal management financial reports, including project financials, capital, headcount, balance sheet and waterfall
  • Quarterly prepare and distribute the internal Board financial reports, including project financials, headcount and waterfall
  • Responsible for the maintenance and update of the R&D manage software to coincide with company and Project Team’s needs
  • Support corporate long range planning process, and other portfolio planning exercises, including the preparation of company, project or Product P&Ls and cash flow
  • Manage ad-hoc information requests and analysis from management and Board Members

EXPERIENCE AND QUALIFICATIONS:

  • 15 + years if related experience in Financial Planning and Analysis
  • Must be knowledgeable in the principles of U.S. GAAP
  • Excellent written and verbal communication skills; ability to work effectively with Senior Executives
  • Strong experience with the use of Great Plains, R&D Manage, R&D time, or related experience with financial business models and financial data retrieval, reporting and analysis software
  • Excellent computer skills (Advanced Excel, Word and PowerPoint skills are required)
  • Experience working within and public company with Sarbanes Oxley Act requirements
  • Experience with financial system implementations and associated testing and required controls
  • An excellent understanding of the biotechnology industry – research process and clinical development
  • High degree of initiative
  • Strong interpersonal skills and a team player is essential
  • Strong presentation skills
  • BA in accounting or finance

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

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46) BioPharma Account Manager/ Recruiter – Full Time (San Francisco or Greater Bay Area)

DESCRIPTION:

  • The position combines recruiting with client account management and acts as the main point-of-contact for our client and contract workforce. 
  • This is an excellent opportunity for staffing industry candidates to partner with a growing company.
  • Work directly with clients as their primary contact.
  • Manage full cycle recruiting process to identify top quality candidates for placement within our client's organization.
  • Creatively source professional candidates online for contract and full time roles
  • Interview applicants and candidates, evaluate technical and soft skill qualifications, submit resumes to client, coordinate candidate/hiring manager interviews and follow up for feedback
  • Maintain and develop ongoing relationships with clients to expand business
  • Maintain ongoing relationships with talent workforce to ensure exceptional customer service, referrals, and possible placement
  • Interact and communicate directly with client's hiring managers to better understand staffing needs, desired job requirements, and to ensure candidate's cultural fit within client's organization
  • Resolve any customer service issues quickly and efficiently to maintain the highest level of client satisfaction and our strategic partnership

EXPERIENCE AND QUALIFICATIONS:

  • 2 or more years of recruiting experience in biotech, pharmaceuticals, medical devices or medical diagnostics
  • 5 or more years recruiting experience, and 2 or more years Account Management experience
  • 2 or more years’ experience as a manager with direct reports
  • Excellent communication, presentation and customer service skills
  • Ability to multi-task and prioritize in a fast paced, dynamic environment
  • Strong attention to detail
  • Strong work ethic and motivation for personal success
  • Bachelor degree in Science; MS or MBA preferred

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

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47) Senior Clinical Research Associate – Full Time (San Francisco or Greater Bay Area) ER111Z

DESCRIPTION:

  • Responsible for managing the day-to-day clinical operation functional activities associated with the execution of the clinical trial. 
  • Managing all activities for a region and managing a Clinical Research Organization (CRO) or third party vendors or other study supportive activities.
  • Perform qualification, initiation, interim monitoring and closeout visits at clinical study sites for data collection, source data verification, review of regulatory documents/files and drug accountability
  • Manage assigned study sites and train the clinical site staff to ensure protocol and regulatory compliance
  • Participate in the CRO selection, management and budget negotiations
  • Participate in the clinical site budget and contract negotiations
  • May assist in or be responsible for development of protocols, informed consents, case report forms, monitoring plans, edit specifications, clinical study reports, and investigator brochures under direction of CTM/CPM.
  • Assist CPM / CTM with projection and management of clinical supplies
  • Coordinate and/or participate in investigator meetings
  • On assigned sites, interact with investigators in protocol development, presentations and publications
  • Responsible for updating study timelines and metrics
  • Provide mentoring to CRAs and Clinical Trial Assistants (CTA’s)

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of GCP and ICH guidelines required
  • Excellent communication and interpersonal skills
  • Detail oriented
  • Able to work within a team
  • Able to perform assignments with general instructions
  • Proficiency with MS Word, Excel, Outlook, and PowerPoint
  • Must be willing to travel (25-40%)
  • Bachelor’s degree in a relevant scientific discipline or equivalent
  • At least 4 years of relevant clinical experience in a CRA functional role in the pharmaceutical industry, biotech or equivalent, with at least 5 years desired in the biotech / pharmaceutical industry or equivalent.
  • 1 year experience as a SCRA or equivalent preferred.

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

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48) SCRA/Clinical Trial Manager – Full Time (San Francisco or Greater Bay Area) B111KN

DESCRIPTION:

  • Responsible for managing the day-to-day clinical operation functional activities associated with the execution of clinical trials, and managing all activities and third party vendors or other activities.
  • Manages clinical study team to ensure that a trial is completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
  • Manages various study team activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports.
  • Manages study sites and trains clinical site staff to ensure protocol and regulatory compliance
  • Manages portions of the clinical site budgets, CRO selection and assist the Contract Group in the development of RFPs.
  • Manages staff who oversee multiple Contract Research Organizations (CROs, including clinical services, data management, bio-statistical services, and central laboratory services
  • Management responsibility for ensuring SOP and regulatory compliance of staff and study teams on one or more trials.
  • Manages study plans, study reports, sections for Investigator's brochures, and regulatory documents (IND, NDA or BLA) on one or more trials.
  • Manages and direct junior staff, CRAs, CRA IIs, CTA’s performing site management efforts.
  • Manages clinical supplies requirement needs determination and ordering supplies for one or more trials
  • Manages the development of clinical monitoring plans and establishes study monitoring priorities.
  • Manages team administrative issues with investigational sites and/or CROs.

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor's degree in a relevant scientific discipline or equivalent
  • 5 years of relevant clinical experience in a CRA functional role in the pharmaceutical industry, Biotech or equivalent, with at least 6 years desired in the biotech / pharmaceutical industry or equivalent.
  • 1 year experience as a CTM or equivalent preferred.
  • Knowledge of GCP and ICH guidelines required
  • Proficiency in the implementation, monitoring, and management of clinical trials
  • Demonstrated managerial and supervisory skills
  • Excellent communication and interpersonal skills.
  • Able to problem solve and use good judgment
  • Able to work within a team and work with general instructions
  • Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project skills preferred
  • Must be willing to travel as required for the project (approx. 25%)

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

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49) (Senior) Manager, Statistical Programming – Full Time (San Francisco or Greater Bay Area) J111YT

DESCRIPTION:

  • Responsible for management statistical programming activities and study related projects while also developing and implementing SAS programs to efficiently produce analyses. 
  • Exercise judgment within generally defined practices and policies in selecting methods and policies.
  • 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, analyses 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
  • Collaborate with other biometrics functions for all activities related to analyses of clinical trial data.
  • Responsible for execution of ad-hoc requests, manuscripts, posters, and presentations.
  • Act independently to determine methods and procedures on new assignments

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
  • Experience with CDISC data standards required. 
  • Knowledge of database and data warehouse theory. 
  • Data mining experience is a plus
  • Experience as a senior statistical programmer level in a pharmaceutical or CRO working in a FDA regulated environment
  • Experience with Clinical Study Reports and NDA submission.
  • Understanding of regulatory guidelines that affect statistical deliverable
  • Ability to work on multiple tasks simultaneously and meet project deadlines
  • Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
  • Communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
  • Minimum of 8 years of SAS programming in the pharmaceutical or biotechnology industry with a BA/BS in computer science, statistics, math or MA/MS with 8 years of experience.

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

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50) Project Director – Full Time (San Francisco or Greater Bay Area) P113DQ

DESCRIPTION:

  • Responsible for the execution of high quality project management to ensure the achievement of sciences’ project goals consistent with the product development objectives. 
  • Will serve as a Project Director for one or more projects, providing leadership and project management expertise directly and via supporting project managers to cross-functional project teams.
  • Will ensure that the utilization of organization, planning, tracking and communication tools and techniques is practiced with high quality and that project managers under his/her direction are performing at high levels of achievement. 
  • Expected to lead and drive the project execution process for all aspects of clinical development across Phases I – IV and across therapeutic indications.
  • Provide project management and leadership to a cross functional development sciences project teams and study teams to ensure timely achievement of project deliverables for a given indication or product(s).
  • Oversee and supervise the performance of supporting project managers having responsibility for study teams.
  • Direct project goal-setting and ensure buy-in by functional areas.
  • Lead the development and execution of project plans to optimally achieve strategic objectives and corporate goals.
  • Achieve high level team performance by ensuring the correct composition of team and functional area expertise is in place and that understanding of objectives, responsibilities, and efficient decision-making is carried out
  • Ensure that timely and consistent communications regarding project strategy, status and decisions are made within the team and to senior management, the company and partners.
  • Develop and maintain strong, collaborative relationships with key stakeholders and represent the projects within development sciences and throughout the organization.
  • Play a central role in the development and implementation of new project management processes and policies to advance the growth and effectiveness of the project function.

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor of Science in the sciences or other technologies required
  • MBA or other advanced degree preferred
  • Certification or professional training in project management a plus

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

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51) Director/Associate Director Clinical Scientist – Full Time (San Francisco or Greater Bay Area) B139MT

DESCRIPTION:

  • Work closely with the VP Global Clinical Development providing medical-scientific expertise to one or more clinical projects. 
  • Development of therapeutics organized in the project team structure. 
  • Represent the clinical function on several sub teams, such as the clinical, diagnostic or biomarker, and Regulatory sub teams.
  • Assuming the role of clinical advocate and representative for a given program
  • Partnering with the VP Global Clinical Development in writing clinical development concepts and plans for molecules at all stages of development
  • Writing initial and later drafts of protocol synopses, protocols and protocol amendments
  • Writing/reviewing informed consent forms and reviewing/adjudicating site-specific ICF requests
  • Partnering with clinical operations on site selection, start-up and communication
  • Writing or updating clinical sections of investigator brochures and leading the team that writes the initial brochure and subsequent annual updates
  • Writing/reviewing clinical/safety sections of BLAs/MAAs
  • Representing the medical (clinical) function on one or more clinical study teams, with functional support from the clinical leader
  • Serving as a member of the clinical sub team
  • Reviewing and interpreting data listings including safety data and serious adverse events
  • Assisting with or serving as primary author of clinical study reports and associated publications
  • Creating clinical study- or program-related slide decks for internal and external use
  • Training of colleagues, CRO and study site staff on the therapeutic area, molecule and protocols as appropriate
  • Organizing and participating in opinion leader advisory boards
  • Contributing to or performing therapeutic area/indication research and competitor analysis
  • Building and maintaining opinion leader/investigator networks

EXPERIENCE AND QUALIFICATIONS:

  • A minimum of 5 years of Industry experience is required
  • Strong knowledge of clinical oncology gained through clinical training, experience or previous clinical development experience in Industry is strongly preferred
  • Candidates with exceptional experience in other therapeutic areas would be considered if they demonstrated clear potential to apply their existing skills to oncology.
  • Previous participation in a clinical development program is required, including involvement in most stages of clinical trials (i.e. from start up to study report)
  • Candidates with a background in closely related functions (eg clinical operations, regulatory affairs, biometrics), having represented their function at project/clinical team level, would be considered
  • Strong writing and communication skills
  • Flexibility to work with colleagues in a global setting
  • Able to engage in work-related travel approximately 35%
  • A postgraduate degree in biologic science is strongly 

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

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52) Senior Director / VP, Process Development & Manufacturing – Full Time (San Francisco or Greater Bay Area) FL161B

DESCRIPTION:

  • Lead a world-class process development group in support of developing a large-scale commercial manufacturing process for vaccines
  • Manage the in-house vector production function utilizing bioreactors for the production of R&D material and will play a key role in coordinating cGMP production at contract manufacturing organizations (CMOs).
  • Lead the vector process development team in the optimization and scale-up of  vaccines.
  • Evaluate and compare novel production methods to existing processes to identify opportunities for yield improvement
  • Manage tech transfer and qualification support to allow implementation and scale-up in a GMP environment. 
  • Manage the in-house R&D vector production function and coordinate production schedules to optimally support the needs of other R&D groups.
  • Work with external CMOs to coordinate the GMP production of bulk drug substance in support of the company’s clinical development programs.
  • Lead the internal investigation and resolution of deviations encountered during GMP production activities
  • Assist in defining critical process parameters, specification setting and controls to define a robust manufacturing process
  • Actively participate in the design and qualification of company manufacturing facilities
  • Supervise, train and mentor staff

EXPERIENCE AND QUALIFICATIONS:

  • The ideal candidate will have extensive experience in the large-scale cGMP production including upstream cell culture and downstream processing.
  • Minimum of 10 years experience in the biotechnology or pharma industry with a primary focus on upstream cell culture process development and manufacturing operations for viral vector and/or biologics
  • Proven track record of managing in-house and CMO GMP production operations
  • In-depth experience with:
  • Mammalian suspension cell culture systems at both pilot-scale and at large-scale
  • Different bioreactor production systems and scales, including stirred tank and WAVE systems
  • Experience with production equipment design and validation, including IQ, OQ, PQ & CIP/SIP a plus.
  • In-depth knowledge of GMP and FDA regulatory requirements
  • Knowledge of quality systems and QBD as they relate to GMP production operations and process optimization
  • Proven managerial skills
  • Outstanding organizational skills
  • Excellent written and oral communication skills
  • Ability to operate in a dynamic, multi-disciplinary environment
  • Occasional travel required
  • MS or Ph.D in bioprocessing, chemical engineering, virology, cell biology, or other relevant biological science.

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

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53) Field Service Specialist – Full Time (San Francisco or Seattle Area) D103GX

DESCRIPTION:

  • Provide highly visible customer support through the performance of on-site installation, training, troubleshooting, service/maintenance , and repair  and support of complex equipment and systems on all levels (hardware and software).  
  • Reviews and approves operational quality of system equipment.  
  • Instructs customers in the operation and maintenance of the system.  
  • Serves as company liaison with customer on administrative and technical matters for assigned projects.  
  • Interprets customers’ needs and identifies if the responsibility for problem resolution falls to sales personnel, or service. 
  • May promote the sale of service products.
  • Install, maintain, repair and support equipment on all levels (hardware, software and applications)
  • Maintain and develop positive relationships with customers
  • Utilize relevant databases to input and provide information that will increase effectiveness
  • Utilize all available tools such as Service Reports, Spare Part & Service Manuals, and ISI Notes
  • Assist in the development and maintenance of reference customers
  • Assist in meeting/exceeding sales targets in relation to maintaining high customer satisfaction
  • Actively promote and sell Field Service products
  • Give active feedback to Sales, Global Product Support and your team/management
  • Manage effective available time and resources
  • Provide cross-border/district/region support when required

EXPERIENCE AND QUALIFICATIONS:


  • Previous experience in biotech or clinical lab environment is a plus
  • Proven work experience in developing customer relationships
  • Willingness to travel national and internationally
  • Good written and verbal English language communication skills
  • Good interpersonal skills
  • Ability to work both independently and in a structured working environment 
  • Travel up to 75%
  • Preferable minimum of 2 years service and support experience in a comparable position within the after sales service business in the Life Science industry/markets, or equivalent experience repairing and maintaining instrumentation in the Life Science or Clinical Diagnostics fields  
  • Mechanical/Electrical Engineering degree, preferable Automation experience

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

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54) Product Management, Director – Full Time (San Francisco or Greater Bay Area) GZ146F

DESCRIPTION:

  • Responsible for the product lifecycle from concept to obsolescence as well as the creation and communication of the product vision by working collaboratively with all sectors of the organization involved in the product lifecycle ( R&D, marketing, sales, engineering, statistics, operations, sales, product support and training). 
  • Responsible for determining market requirements and recommending product strategies and pricing based on market intelligence and customer feedback by analyzing and assessing the market and the competition as well as the needs of the customers to identify growth opportunities that align with existing or planned capabilities. 
  • Help measure current profitability as well as plan for future growth. 
  • The successful candidate must be an experienced, technically strong professional who is a results-oriented team player.
  • Understand market conditions and translate them into product requirements resulting in improved customer satisfaction and increased value generation
  • Conduct interviews as means to validate New Product Development (NPD) and PI plans and to help sales develop long term customer relationships
  • Participate in helping the support and service teams develop their offering
  • Provide input to annual operating plan and strategic plan
  • Work closely with R&D in tracking the new product development process
  • Determine product line rationalization programs if required
  • Work with Manufacturing, Operations and R&D to define product line cost reduction or improvement programs to improve overall margin performance whilst fulfilling or exceeding customer requirements and expectations in a competitive landscape
  • Work with marketing personnel throughout the division to leverage technology, increase solution scope and rationalize product lines as required
  • Collaborate with internal and external stakeholders to create a distinctive product vision
  • Provide internal and external stakeholders with the appropriate updates on progress, vision, and product roadmap
  • Continue to refine product vision based on feedback from end users, working team, and internal and external thought leaders.
  • Work with New Business Development and sales throughout the corporation to help maximize business opportunities
  • Provide input to the quality management system/documentation
  • Defines complete product lifecycle from concept to obsolescence
  • Defines future product line requirements and validation of functional specifications
  • Support product marketing in the definition of product positioning – from market launch plans to delivering key collateral content to marketing communications
  • Provide guidance and support to the commercial team on product pricing and pricing strategy to maintain a margin target
  • Problem solving and critical thinking across multiple domains
  • Communication and training of support, sales and marketing on product capabilities and positioning
  • Manages and mentors more junior product managers

EXPERIENCE AND QUALIFICATIONS:


  • Ability to understand technology and articulate strong customer value/benefit propositions is critical.
  • Project/process management skills required.
  • Strong computer skills in office applications (e.g., MS Word, MS Excel) and presentation tools (e.g., MS PowerPoint) required.
  • Proven ability to function in a highly matrixed organization
  • Proven excellence in both written and oral communications skill.
  • Proven ability to lead and motivate a cross-disciplinary team.
  • Proven organizational skills and attention to detail.
  • Bachelor’s degree required, preferably in physical or life science, chemistry or engineering discipline. 
  • MS or Ph.D. with emphasis in molecular biology, bioinformatics, or life-science instrumentation preferred.
  • 5+ years of product/solution marketing, product commercialization or product management experience with particular expertise and experience in the Life Sciences industry.

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

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55) Senior Manager, Patient Advocacy Oncology – Full Time (San Francisco or Greater Bay Area) YR113J

DESCRIPTION:

  • Responsible for engaging with key patient advocacy and other external community stakeholders to support timely clinical trial recruitment and retention.  
  • Will serve as the relationship manager for key patient advocacy organizations in partnership with other functional areas, and will liaise with patient communities and internal stakeholders (clinical operations, clinical science, etc.) to support the organization’s patient-centric culture.  
  • Responsibilities include development and implementation of specific patient advocacy programs and materials focused on patient education and clinical trial recruitment.  
  • Collaborate with internal colleagues to create program-specific patient advocacy strategic plans and tactics in support of trial recruitment and retention.
  • Align advocacy plans with operational plans for support of trial recruitment and retention and corporate goals as applicable.
  • Develop a strong network of contacts with targeted organizations and leads relationship building and activities of mutual interest with these stakeholders. Serves as the liaison responding to issues, needs, concerns, and requests in an appropriate, coordinated and timely fashion.
  • Identify patient organizations and related groups that can support the company’s effort with patient recruitment and retention.
  • Represent patient advocacy on cross-functional teams, partnering with teams and advocating internally for the role and importance of third party alliances. 
  • Gather insights on the needs and challenges of the patient community and share information internally to ensure they are considered and will inform strategic decisions by product development teams. 
  • Collaborate with local/regional affiliates to ensure relevant information on advocacy initiatives are shared.
  • Oversee development of patient recruitment strategies and trial-specific patient materials that support project teams in clinical trial patient recruitment efforts. 
  • Create and deliver patient-focused communication materials in close cooperation with other internal stakeholders. Develops detailed timelines for materials/activities and oversee these timelines until materials are delivered or activities completed.
  • Contribute to improvement of processes, systems and tools for patient recruitment and retention activities.
  • Evaluate the effectiveness of advocacy initiatives, monitoring progress against expectations/objectives.
  • Lead specific advocacy initiatives to ensure maximum impact and that desired goals and objectives are met.
  • In collaboration with Director, identify and manage patient recruitment/communication agencies.
  • Serve as the company representative at national and international meetings. Participate in committees or corporate advisory councils of organizations, as appropriate.
  • Support departmental efforts to establish standards and best practices in patient advocacy relations and communications

EXPERIENCE AND QUALIFICATIONS:

  • Experience in oncology.  
  • Strong understanding of the drug development process, including all aspects of clinical trial planning and execution (patient recruitment and retention).
  • Good knowledge of FDA regulations, HIPAA and ICH/GCP guidelines.
  • Knowledge of legal/compliance environment and local/regional regulations that impact advocacy initiatives and communications.
  • Demonstrated understanding and knowledge of the principles of effective advocacy and its role in drug development.  Have a passion for clinical research and patients.
  • Proven collaboration and teamwork skills.  Ability to work closely with and collaboratively with cross-functional colleagues as well as external customers.
  • Minimum 2 years  project management experience.  Strong planning and organizational skills and attention to detail.  Able to set priorities and manage multiple programs.
  • Strong verbal and written communication and customer relations skills.  Flexible and able to relate with patients, families, researchers and advocates, develop rapport quickly and demonstrate empathy.
  • Demonstrate initiative and consistently deliver high-quality work products.
  • Travel up to 50% (domestic and international) and willing to work off-hours to attend events and activities.
  • Minimum of 6 years of experience in pharmaceutical/biotech industry, with prior experience in a clinical research environment, specifically patient recruitment, investigator relation or relationship management.
  • University degree in a health or business-related field required.  
  • Advanced degree preferred.

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

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56) Director of Portfolio & Program Management – Full Time (San Francisco or Greater Bay Area) AM146P

DESCRIPTION:

  • Establishing the Portfolio and Program Management function at redesign or augmentation of existing processes and structures or creating new ones as required.
  • Managing the portfolio of projects, highlighting tradeoffs and resource allocation to help senior management align projects with the strategic priorities of the company.
  • Facilitating the project planning process by creating comprehensive timelines; assisting in optimizing resource usage while considering dependencies and priorities.
  • In conjunction with functional leads, developing staffing plans for the R&D teams.
  • Managing a team of project / program managers.
  • Assisting the team in adhering to the QMS, including creation and completion of QMS related documents.
  • Maximizing team efficiency by improving QMS processes and documents.
  • Working with finance to ensure project portfolio maximizes return on investment.
  • Communicating portfolio across the company and ensuring alignment of priorities; tracking and managing changes to the plan; maintaining a dashboard of the current plan.
  • Capturing and highlighting risks in the portfolio

EXPERIENCE AND QUALIFICATIONS:

  • Experience with project management tools such as MS Project.
  • Clear and persuasive communicator.
  • Very proactive and able to take substantial initiative. 
  • Ability to handle multiple complex projects while tracking all details and their completion.
  • Demonstrated competency in strategic thinking and leadership.
  • Demonstrated experience in managing resources to meet goals across multiple projects.
  • Experience working cross functionally with multidisciplinary teams.
  • §Understanding of regulatory and compliance bodies and guidelines such as CLIA, FDA, SOX, CE and IEEE is highly advantageous.
  • Minimum 10 years of program management experience developing highly technical regulated products in the biotech or medical device industries.
  • Master’s degree in science or engineering.

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

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57) Senior CMC Regulatory Program Director – Full Time (San Francisco or Greater Bay Area) AB100Z

DESCRIPTION:

  • Responsible for developing global regulatory strategy, writing high quality dossier and leading teams for assigned projects to obtain timely approvals of applications for small molecule products
  • This position will require regular interaction with management from multiple internal functional areas, corporate partners, international regulators and external experts.
  • Supervise direct reports, and will be responsible for coaching, performance management and talent development.  
  • Lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities. 
  • Support the US affiliate and primarily work on the US filings. 
  • The candidate may be requested to work on ex-US filings as appropriate and as requested by corporate partners. 
  • Additional responsibilities will include leading departmental operational excellence and business process initiatives, as well as, proactively communicate with regulatory and cross functional personnel and partners in support of internal and partner associated goals.
  • Must maintain a high level of professionalism, efficiency, and commitment. 
  • Demonstrate effective problem solving, strong understanding of regulatory affairs, excellent interpersonal skills and the ability to prioritize multiple tasks. 

EXPERIENCE AND QUALIFICATIONS:

  • Must have a proven ability to communicate effectively in both a written and verbal format. 
  • Ability to work both independently or collaboratively in a team structure. 
  • Have a proven ability to work well under pressure. 
  • Skilled to lead communications with FDA and regulatory agencies to facilitate review and approval of submissions.
  • The ideal candidate will have strong experience in Regulatory CMC, as well as, pharmaceutical development experience. He/she must be detail oriented with strong leadership skills and excellent interpersonal and communication skills. 
  • Supervisory experience desired. 
  • The candidate may be required to travel occasionally. 
  • The candidate must possess an advance degree in sciences (PhD preferred) with 12-15 years of experience in pharmaceutical industry 

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

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58) Senior Director - Clinical Operations – Full Time (San Francisco or Greater Bay Area) B139KP

DESCRIPTION:

  • Clinical trial execution and oversight
  • Oversee tactical implementation of the clinical development plan by managing the timeline, resources, budget, and staff of clinical activities
  • Oversee and maintain the relationship with Contract Research Organizations and investigative sites. Typically travels to field sites to supervise and coordinate clinical studies
  • Write clinical operation sections of regulatory documents including protocols, Investigator Brochures, IND annual reports, and others as needed or requested
  • Develop study feasibility and cost estimates for outsourced work
  • Analysis of protocol to produce investigational product (IP) forecasts, identify IP import and regulatory issues, IP distribution and storage requirements and IP labeling requirements
  • Build trial operational infrastructure
  • Partner with supervisor to develop staff, structure department, and create a highly desired work environment for attracting and retaining highly qualified clinical operations professionals
  • Develop and ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines
  • Evaluate and analyze tools and processes to support outsourcing efforts
  • Work with Clinical Operations team to identify and develop efficient systems for enhancing department efficiency
  • Develop and direct process for prequalification of vendors; Request for Proposal (RFP) processes and policies
  • Interface effectively with other groups within the organization
  • Maintain a high level of professional expertise through familiarity with clinical literature 
  • Work with senior management to develop and to achieve corporate goals and work with clinical operations staff to achieve the established corporate goals within the expected time frames
  • Participate on project teams and study teams as needed or requested
  • Act as key resource to provide financial information related to clinical development.  Interface with finance group to manage trials costs
  • Collaborate with legal department to develop improvements to document templates, standard processes and tools

EXPERIENCE AND QUALIFICATIONS:

  • Excellent working knowledge of FDA & ICH/GCP regulations and guidelines and experience building clinical operations groups and associated infrastructure.
  • Demonstrated project management/clinical operations experience and leadership skills (e.g., managing cross functional  study teams, managing outside collaborators)
  • Strong communication skills (verbal and written); effective in interaction with senior management
  • Excellent judgment and problem solving skills
  • Hands-on ability to think strategically and tactically
  • Entrepreneurial spirit with can do attitude, commitment to teamwork, and initiative
  • Knowledge and experience with managing contracts (vendor and site) and interface with finance group
  • Experience managing an operations staff
  • BA/BS degree or higher, preferably in the life sciences
  • Minimum of 10 years prior relevant experience in the pharmaceutical/biotech industry or relevant clinical research organization, with a minimum of 5 years staff management experience

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

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59) Sr Assoc.Director/Director/ Sr Director, Biostatistics-Clinical Pharmacology – Full Time (Massachusetts) MP153G

DESCRIPTION:

  • Accountable to lead the clinical pharmacology biostatistics team to support multiple complex projects. 
  • As a leader in biostatistics, will provide strategic, scientific input to the strategy coordinating, and modeling and simulation groups to ensure high quality data and modeling to support drug development. contribute to the strategy, including innovative statistical designs, exposure-response analyses, statistical expertise for regulatory documents and for key decisions and scientific communications.
  • Ensure that the portion of clinical development programs under his/her responsibility meet scientific, regulatory, quality and commercialization requirements, through interactions within Global Project Team (GPT) and International clinical team (ICT).
  • Be a core member of the Core Team. 
  • Identifying opportunities to utilize innovative trial designs and statistical analysis methods in drug development using model based and statistical approaches. 
  • Proposing and developing innovative designs and analysis methods and evaluating them via simulation studies and other appropriate methods.
  • Interacting with clinical teams to ensure the proper implementation of innovative approaches in clinical trials and development programs.
  • Be a scientific leader/expert showing leadership / be the point of reference in statistical methods, regulatory guidelines, and clinical pharmacology and exposure-response analyses.
  • Ensure the quality of statistical input, and exposure-response analyses integrating expertise across different functions (e.g., CP, Modeling and Simulation), as well as from external statistical experts, into the strategy. Initiate and drive innovation by implementing novel methods and innovative designs to input into and support project strategy. Accountable for line function review of Biostatistics deliverables throughout the project.
  • Plan, prioritize and track activities across projects. 
  • Plan and manage submission activities for all aspects, including Summary Clin Pharm, Health Authority responses and Briefing Books.
  • Lead and/or support functional or cross-functional initiatives as needed, including project planning, budget planning, goal setting, effective utilization of team diversity and obtaining appropriate commitment.
  • Support and defend statistical/modeling methodology and/or analyses/simulations and their use/interpretation at Health Authority Meetings
  • Represent in statistical discussions at external congresses, conferences, scientific meetings

EXPERIENCE AND QUALIFICATIONS:

  • Master Degree in Statistics or Mathematics (or equivalent degree) with at least 9-12 years of relevant experience or PhD in Statistics with at least 6-8 years of relevant experience with exposure to modeling and it’s usage in clinical trial design.
  • Baysean knowledge is an asset
  • Experience in all tasks of a lead statistician (about 5 to 7 years), including submission and significant Health Authority experience.
  • Strong knowledge and expertise in statistics and its application to pharmacology in clinical trials; able to explain statistical designs and concepts.
  • Expert knowledge and experience in drug development process, Clinical Pharmacology, HA guidelines and submissions.
  • Record of successful implementation of novel methods and/or innovative strategies
  • Knowledge of statistical software packages (e.g. SAS, R)
  • Very good communication and presentation skills. 
  • Ability to influence and communicate across functions.
  • Proven strong leadership and project management skills. 
  • Demonstrated ability to have managed functional/multi-functional teams and/or initiatives. 
  • Good coaching and mentoring skills. Fluent English (oral and written).
  • This position has no direct reports.

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

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60) Recruitment Account Manager – Contract or Full Time (San Francisco or Greater Bay Area)

DESCRIPTION:

  • Will need to understand the recruitment industry and have previous recruitment experience either in-house or in agency as a recruiter. 
  • Responsible for several clients.
  • Account management / sales experience.
  • Directly manage recruitment staff
  • Review and analyze business metrics including data on recruiters candidate submissions, interview and placement rates
  • Previous recruitment industry experience working in-house or in-agency 
  • Good appreciation / understanding of recruitment services.
  • Able to work collaboratively with Operational and Technical colleagues.
  • Develop knowledge of the latest trends and developments within recruitment
  • Credibility in dealing with contacts.
  • Build strong and enduring relationships with clients.
  • Has understanding of project implementation and ongoing management processes.
  • Commercial awareness with regards to revenue opportunities.

EXPERIENCE AND QUALIFICATIONS:

  • Strong communication skills.
  • Good presentation skills.
  • Meeting management.
  • 6-10 years of experience working with mid to senior levels of an organization with involvement in strategic decision-making
  • 3+ years in a small biotechnology, pharmaceutical or medical device/ diagnostics company with experience in recruiting
  • 3+ years of direct management experience.  
  • Management of recruiting personnel a plus.
  • Demonstrated experience driving organizational and culture change initiatives, developing workforce plans in a high-growth organization, and influencing challenging personalities
  • Strong project management, effective organizational skills, business and HR acumen, including strong problem solving skills, critical thinking and analysis with high attention to detail a must
  • Bachelor’s degree required; BS preferred

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

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61) CRA II / SCRA – Contract or Full Time (San Francisco or Greater Bay Area) GR132M

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

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62) Senior Clinical Financial Analyst – Full Time Position (San Francisco or Greater Bay Area) RM133B

DESCRIPTION:

  • Financial liaison with Clinical Research & Development and Regulatory Affairs & Compliance and the finance department.  
  • Responsibilities include budgeting and forecasting, project tracking and accounting and monthly close responsibilities.   
  • Works closely with department managers and ensures the accurate and timely processing of monthly accruals, accounting entries, budgeting and forecasting information and ensures appropriate accounting and internal control procedures are followed.  
  • Supports the preparation of monthly financials and analyzes results against budgets and forecasts.
  • Responsible for working with Clinical Research & Development (CR&D) and Regulatory Affairs & Compliance department heads on the financial deliverables that each department is responsible for and ensuring that the information is processed and incorporated in the company’s actual financials, budgets and forecasts.
  • Responsible for all monthly close responsibilities in accordance with accounting procedures and timelines. 
  • Work closely with department heads in developing their outsourced and capital expense budget and forecasts in sufficient detail to provide monthly project tracking throughout the year.
  • Summarize financial terms and accounting treatment for all new contracts, work orders and change orders
  • Communicates with CR&D and Regulatory Affairs & Compliance vendors to negotiate budgets and create appropriate payment plans
  • Works closely with Clinical Operations in the development of clinical site budget templates for each clinical trial and negotiates final budgets with each clinical site for inclusion in the site contract
  • Participates as a member of all Study Management Teams for each clinical trial
  • Issue purchase requisitions in accordance with the contracts, work orders and change orders and ensure they appropriately funded within the Board approved budget or forecast
  • Track all invoices and activity against contracts, work orders and change orders and any uninvoiced work performed and prepare accrual information, in accordance with required accounting procedures, for approval by the respective department or functional area head and review by the Director of Accounting Operations.
  • Coordinate with third party vendors to obtain updates on all contracts, work orders and change orders.
  • Works closely with both CR&D and Finance departments to establish and provide oversight of a clinical site payment vendor for multi-center global clinical trials
  • Process invoices for approval by ensuring charges are in accordance with the terms for the respective agreements and that they are coded to the correct projects and that the purchase order has sufficient funds for payment processing.
  • Ensure change orders are generated in a timely manner when the scope of work changes.  
  • Works with CR&D and Regulatory Affairs & Compliance departments to ensure work performed is captured in the monthly accrual process by organizing and leading monthly pre-accruals meetings.
  • On a monthly basis, prepare key financial reports for Senior Research, Development and Alliance Management personnel that cover the internal and external spending on partnered programs.
  • Provide training on finance concepts to department heads as necessary.
  • Assist with vendor confirmations, to verify account balances and project status.
  • Provide monthly variance analysis to department managers.
  • Facilitate and monitor compliance to project schedules and timelines
  • Collaborate with other departments to provide information required for successful financial management of CR&D projects 
  • Updates and tracks multiple study costs in a timely and accurate manner

EXPERIENCE AND QUALIFICATIONS:

  • Clinical Research & Development experience required.
  • Strong knowledge and understanding of GAAP accounting and financial principles
  • Outstanding analytical skills and proven ability to connect business issues with financial analysis
  • Experience with project tracking and accounting
  • Experience with clinical trial payment software
  • Excellent oral and written communication skills
  • Advanced Excel skills
  • Self-starter with excellent work ethic 
  • Experience operating within a Sarbanes-Oxley control environment
  • Excellent problem solving and interpersonal skills
  • Bachelor's degree in Accounting, Finance or Business
  • 8+ years accounting and financial planning experiences

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

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63) Field Application Scientist – Full Time (San Francisco or Greater Bay Area) BZ146J

DESCRIPTION:

  • Provide technical support to research and clinical teams worldwide
  • Assist partners remotely or on-site as needed, respond to inquiries in timely and professional manner, provide ongoing training.
  • Become an expert on company technologies: troubleshoot and deliver solutions to partner’s problems.
  • Develop new partnerships: conduct site evaluations, provide logistics support and initial training including technical presentations and hands-on assay demonstrations.
  • Plan and execute experiments supporting technology transfer and partner support activities (e.g., workflow changes, replicating / confirming partner’s results).
  • Generate technical documentation, training materials and reports.
  • Develop and maintain positive working relationships with internal teams (sales, business development, R&D) and external collaborators.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent organizational, analytical, and troubleshooting skills with in-depth knowledge of molecular biology methods including DNA sequencing, qPCR, PCR, and related methods.
  • Very strong written and verbal communication skills and high level of responsiveness required.
  • Ability and willingness to travel internationally 10 - 50% of time.
  • Familiarity with various medical device regulations such as CLIA, CAP, 21CFR 820, 806, 803, 210, 211, European In-Vitro Diagnostic Directive 98/79/EC, and EN ISO 13485:2012 preferred.
  • M.S. or Ph.D. in molecular biology or closely related field and at least 4 years of experience in technical field support or molecular assay development

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

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64) Director, Biostatistics – Full Time (San Francisco or Greater Bay Area) D113HX

DESCRIPTION:

  • The Director of Biostatistics is a lead Biostatistician with training and significant experience in statistics, drug development and clinical research.  
  • Provide biostatistics and biometrics leadership and oversight for all phases of clinical trials and drug development programs, including regulatory submissions.  
  • Responsible for production of biostatistics deliverables by supervising one or more statisticians. 
  • Participate in overseeing the performance of Contract Research Organizations (CROs), developing standard reporting programs, and standard CRFs in collaboration with cross-functional groups 
  • Works with clinical scientists, statistical programmers, clinical operations, and other statisticians to plan clinical studies, and to analyze and interpret clinical study data
  • Participates in new drug development programs as a Subject Matter Expert (SME) in statistics area and provides statistical leadership in the design of clinical development plans
  • Responsible for production of the following study-related deliverables, either personally or by supervising one or more statisticians: appropriate sections of study protocols, case report forms, statistical analysis plans, data analyses, manuscripts, and sections of clinical study reports and registration documents.
  • Responsible for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies
  • Works with the department head and peers to develop and monitor the department strategic direction and its alignment with company strategies.
  • Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.
  • Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines.

EXPERIENCE AND QUALIFICATIONS:

  • A minimum of 10 years clinical trial experience in pharmaceutical and/or biotech company.
  • Advanced knowledge of statistical methods in clinical study designs, clinical data analyses (from Phase I through Phase IV), including statistical procedures in analysis software (eg, SAS).
  • Extensive hands-on experience on statistical analysis plans, study protocols, clinical study reports, integrated summary of safety and efficacy reports, Investigator Brochures, and annual reports (or periodic safety update reports).
  • In-depth knowledge of clinical operations, data management, and clinical study report preparation workflow.
  • Advanced knowledge of theoretical and applied statistics.
  • In-depth knowledge of statistical analysis methods and results/data presentation formats of clinical data.
  • Exhibition of comprehensive exemplary experimental techniques, following procedures with the utmost rigor and attention to detail.
  • Experience in leading or participation in at least one electronic NDA and/or BLA submissions via eCTD.
  • Familiar with IND or CTA.
  • M.S. in Statistics or Biostatistics required
  • Ph.D. in Statistics or Biostatistics preferred

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

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65) Associate Director / Director, Biostatistics – Full Time (San Francisco or Greater Bay Area) FM129R

DESCRIPTION:

  • Will act as the leader and project manager for all biostatistics and statistical reporting deliverables in support of one or more clinical development programs.
  • Coordinate the work of biostatisticians, programmers and data management personnel and at vendors, and play a critical role in a Phase III development program and global regulatory submissions
  • Provide strategic and operational statistical expertise for clinical development programs
  • Provide protocol development including endpoint assessment and sample size/power calculations
  • Write and critically review statistical section of protocols, reports and analysis plans
  • Instruct analysis work implemented by SAS programmers
  • Critically review IVRS instructions, data management plans and other study documentation
  • Plan and manage submission activities
  • Represent the company at FDA meetings, including Advisory Committee meetings

EXPERIENCE AND QUALIFICATIONS:

  • Proven knowledge and expertise in statistics and its application to clinical trials
  • Solid knowledge and experience in drug development process
  • Knowledge of statistical software packages including SAS
  • Prior experience with regulatory submissions and interactions with the FDA and global regulatory authorities required
  • Able to thrive in a small group setting with minimal oversight, possesses high energy hands-on attitude
  • Strategic thinking, strong leadership, cross-functional collaboration, oral and written communication skills and presentation skills required
  • Up to 5% travel
  • Masters Degree in Statistics (or equivalent degree), PhD preferred, with 8+ years of pharmaceutical experience

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

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66) QA Specialist / Sr. Quality Assurance Specialist – Full Time (San Francisco or Greater Bay Area) HN82Q

DESCRIPTION:

  • Responsible for CMO compliance and Final Product Release.  
  • Document compliance for Batch Release – such as batch records, QC test results, deviations, and change controls.  
  • Contribute to SOP/batch record generation and revision and the generation of documentation metrics.   
  • Perform batch record and QC test results review to ensure compliance with cGMP and 21 CFR to support the release of product.
  • Prepare lot package for release.
  • Track and trend batch record errors.
  • Initiate incident reports during batch record review (if necessary) and provide support during investigations.
  • Create and revise Standard Operating Procedures (SOPs), as required.
  • Review Deviations, CAPAs, and Change Controls.
  • Participate in internal audits.
  • Assist in generating and maintaining quality metrics.
  • Support the quality team during regulatory inspections.
  • Assists and may lead on special projects with moderate complexity and other responsibilities as assigned.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork

EXPERIENCE AND QUALIFICATIONS:

  • Must possess cGMP knowledge  to understand and effectively review manufacturing and QC test records.
  • Strong to excellent technical writing and editing skills.
  • Computer skills: Proficient with Word, Excel, Visio, PowerPoint and Adobe Acrobat. 
  • Must be an effective verbal and written communicator with proven abilities to communicate complex information and concepts with clarity.
  • Strong to excellent organizational skills with the ability to effectively prioritize, manage multiple projects and tasks as well as have a great attention to detail.
  • Must have the ability to proactively resolve issues in a diplomatic, flexible and constructive manner.
  • The ideal candidate is self-motivated and directed; works effectively independently as well as in a team environment.  
  • A BA/BS and for the QA Specialist at least 5 years’ relevant experience.  The Sr QA Specialist  will have at least 8+ years’ relevant experience.

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

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67) Staff Mechanical Engineer – Full Time (San Francisco or Greater Bay Area) PZ73N

DESCRIPTION:

  • Responsible for the development of various analytical instruments for the life sciences market. 
  • The ideal candidate would have at least 8 years experience in the mechanical design of precision subcomponents of the instrument.   
  • The candidate must have demonstrated the ability to develop successful products from the beginning to the end

EXPERIENCE AND QUALIFICATIONS:


  • Have a strong understanding of packaging mechanical and electronic assemblies, and be familiar with UL/CE/TUV regulations and EMI reduction.  Should also be familiar with ISO 14385 or have design regulation experience. 
  • Well versed in various metal fabrication techniques including casting, sheet metal fabrication, as well traditional machining methods.
  • Well versed in plastic manufacturing such as injection molding and RIM molding as well as 3D printing.
  • Demonstrated strong user in a 3-D CAD package such as ProE Wildfire (preferred) or SolidWorks.  This includes taking conceptual industrial designs and developing them into manufacturable parts.
  • Have ability to create manufacturing drawings and documentation with practical knowledge of general drafting practices and Geometric Dimensioning and tolerancing per ASME/ANSI standards.  
  • A strong knowledge of DFMEA/DFM/DFS, Design for Six Sigma (DFSS)
  • A team player with the ability to work with team members across disciplines plus Have good trouble-shooting skills, creative thinking and a positive attitude.
  • Must have a strong academic background with a minimum of a BS in mechanical engineering
  • Must have at least 8 years hands on experience in the mechanical design of precision mechanical subsystems for analytical instruments in the life sciences or medical device industry.
  • Must have experience in a 3-D CAD package such as ProE Wildfire (preferred) or SolidWorks.
  • Must have demonstrated good trouble-shooting skills, creative thinking and a positive attitude.
  • Project planning and cost forecasting preferred
  • Experienced in advanced modeling techniques for stress analysis (FEA) or thermal (CFD) preferred
  • General knowledge of genomic cell biology and PCR preferred 
  • A strong academic background with a minimum of a BS in mechanical engineering.
  • 8 plus years hands on experience in developing precision mechanical subsystems for analytical instruments or medical devices including: opto-mechanical and mechatronic components in a regulated environment.   Must also have demonstrated the ability to successfully transfer designs to manufacturing. 

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

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68) Supply Chain Associate / Assistant – Full Time (San Francisco or Greater Bay Area) RA111H

DESCRIPTION:

  • Providing support to managers in transferring the Clinical Trial Material (CTM) from manufacturers to the Clinical Research Organization (CRO) and sites. 
  • Plan and organize the whole process. T
  • Assist on some clerical and administrative duties and also maintenance of depots and central depots.
  • Ensure CTM are shipped on time from the CRO to the clinical sites or depots.
  • Review all documentation such as invoices, bills and other supply documents
  • Prepare shipping documentation
  • Analyze items and check the quality of materials before preparing them for dispatch
  • Resolve customer complaints and problems
  • Ensure goods reach the correct site or depot.
  • Monitor the stock levels.
  • Follow the current SOPs and comply with all Good Manufacturing Practices (GMP) rules and regulations.
  • Establish and maintain collaborating relationships with clinical, QA, QC, CROs and supply chain staff
  • Perform research activities in order to identify new solutions for logistical challenges
  • Perform several clerical duties for management
  • Assist the supply chain manager in planning and organizing the distribution of labels, CTM and comparators.

EXPERIENCE AND QUALIFICATIONS:

  • Prior experience in logistics or transportation is considered a plus.
  • Prior biotech experience is highly desirable.
  • Strong oral and written communication skills
  • Highly organized self-starter and efficient in time management
  • Customer service skills and knowledge of GMP and GCP.
  • Ability to perform well without close supervision
  • Multi-tasking and attention to details
  • Rational, analytic thinking and team player
  • Computer skills include Excel, word.
  • Dynamic, enthusiastic, self-motivated and hard working
  • Able to work under pressure and meet deadlines
  • Good geographical knowledge
  • Bachelor's degree of science or related field
 

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

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69) Sr Mgr/AD Clinical Document Control & Training – Full Time (San Francisco or Greater Bay Area) GX82P

DESCRIPTION:

  • Provide leadership and management oversight of clinical document control and clinical training.  
  • Partner with clinical development, QA, and regulatory affairs to enable the development and maintenance of Standard Operating Procedures (SOPs) and clinical documents.  
  • Ensures clinical development is appropriately trained on SOPs.  Manage and oversee the team responsible for the clinical document room and maintenance and tracking of training records. 
  • Develop and manage processes and procedures for Clinical Development which may include SOPs, work instructions, and guidelines. 
  • Provide guidance and advice in document development and control methods as needed.
  • Oversee the development, implementation, and training of clinical document management system.  
  • Partner with QA and Vice President of Clinical Operations to establish and maintain a clinical document control system. 
  • Lead the clinical document control team in preparing for and participating in an audit and/or regulatory inspection. 
  • Recruit, mentor, manage and retain a department of clinical document control professionals, including full-time employees and consultants
  • Review SOPs for content, completeness, regulatory compliance, formatting and consistency with other related documents. 
  • Oversee the review and approval process of clinical SOPs, work instructions, guidelines, and other clinical documents. 
  • Conduct training of Clinical SOPs. 
  • Ensure the appropriate training is acquired, respond to staff training gaps and needs and administer tailored training to clinical staff on an on-going and as needed basis. 
  • Work with clinical and QA management to set compliance training priorities 
  • Support the organization in maintaining a work environment focused on quality and one that fosters learning, respect, open communication, collaboration, integration, and teamwork. 

EXPERIENCE AND QUALIFICATIONS:

  • Experience in developing SOPs and administering training is a must.
  • Experience with electronic filing system preferred
  • Current knowledge of regulations and clinical development process 
  • Effective communication skills to efficiently disseminate information within clinical as well as other functional areas as appropriate. 
  • Organized and highly developed management skills to execute deliverables.   
  • Staff management experience of at last 3 years is required. 
  • Collaborates effectively with the clinical development functional teams, cross-functional team members, and external partners. 
  • Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook.
  • Bachelor’s Degree with 10+ years’ clinical operations and clinical documents and standard operating procedure experience or equivalent work experience and at least 5 years’ management experience.

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

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70) Team Leader (Sr Director to VP Level) – Full Time (San Francisco or Greater Bay Area) R155JM

DESCRIPTION:

The Team Leader provides strategic scientific, business and operational leadership and direction of the R&D development and advancement, including lead candidate, for multiple indications.  In addition to developing and driving a comprehensive lifecycle portfolio strategy, the Team Leader shall be responsible for leading a cross functional leadership team of both internal and external resources in all aspects of development from the pre-IND stage through late stage development, ensuring consistent high quality output from the team and achievement of program goals and objectives.  Includes responsibility for effectively partnering with executive management and key internal and external stakeholders to set the overarching objectives and strategies, as well as driving effective execution of such strategies by leading the cross functional team’s engagement, integration, coordination and communication across functional lines.  Also includes managing R&D partnerships, helping to build necessary infrastructure for the R&D organization and work with the executive leadership to create an environment that supports rapid and high quality decision making (both for the portfolio and the organization) and to identify, evaluate and find solutions for key issues facing the programs on an ongoing basis.

RESPONSIBILITIES:
  • Partnering with internal and external stakeholders to drive the development of a comprehensive strategic plan through registration and pre-commercialization preparation, including goals, budget and risk assessment.  Includes developing program vision, strategy, scope/focus, milestones, risk assessment and management strategies, as well as project investment requirements.
  • Leading cross-functional Project Team focused on the development lead clinical candidate, from pre-IND through late stage clinical development and NDA submission for multiple indications.  Project Team shall include representation from Research, Development, CMC, Regulatory, Quality, Commercial and Finance.
  • Providing effective leadership and direction to the cross functional Project Team, including scientific and operational oversight of activities, budgeting and planning.
  • Utilizing his/her understanding of disease biology, global drug development and portfolio management within the field of Neuroscience and/or Autoimmune disorders to effectively lead the Project Team.
  • Partnering with executive team to develop operating framework within R&D, including with regard to the Project Team, to clarify and facilitate decision-making and escalation around strategic direction, resource allocation, etc.  
  • Partnering with functional areas to identify and ensure adequate resources for timely completion of  goals and objectives.  Ensuring team members understand program objectives, specifications, deliverables, timelines, and tasks.
  • Driving the development and implementation of lifecycle portfolio strategy and follow-on drug candidates for multiple diseases.
  • Managing and communicating program progress on a continual basis, identifying both cross-program and cross-functional issues, resource issues, 
  • Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles
  • Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results
  • Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people
  • Ensures budgets and schedules meet corporate requirements
  • Creates formal networks involving coordination among groups.  Regularly interacts with executives and/or major internal and external customers
  • Works on abstract problems across functional areas of the business.
  • Identifies and evaluates fundamental issues for major function areas through assessment of intangible variables. In-depth knowledge of functional areas, business strategies and company goals.
  • Interacts internally and externally with executive level management requiring negotiation of matters to influence policymaking bodies both internally and externally.
  • Anticipates potential roadblocks and issues of conflict and maintains open lines of communication in problem solving and resolving issues and conflict.

EXPERIENCE AND QUALIFICATIONS:

  • The successful candidate should have an advanced degree in life sciences or medicine (MD or PhD) and or an MBA.  
  • Have at least 10 years of industry experience in drug development, including experience in early phase non-clinical and clinical drug development, regulatory knowledge and pre-commercial market preparation.
  • Prefer scientific or industry experience within the Neuroscience or Autoimmune field
  • Have a proven track record of being a results oriented leader and will have 5+ yrs. leading, managing, and developing program related teams
  • Experience leading and motivating teams in a matrix environment is required. Proven interpersonal skills with ability to influence, resolve conflict and drive decisions among internal cross functional teams, executive management, and external teams.
  • Ability to develop and execute complex strategies.
  • Ability to effectively collaborate in and across multiple
  • Strong decision-making skills taking multiple perspectives into account and analytical skills are required; exercises sound business judgment that has broad organizational impact.
  • Excellent communication skills (both orally and written) is critical to the success of the role.
  • Good at developing the processes necessary to get things done, knows how to organize people and activities, and knows what to measure and how to measure. 
  • Demonstrated ability to interpret data into actionable items
  • Proven negotiation skills that effectively drive discussions and decisions to desired end-results that have broad organizational impact.
  • Skilled in establishing a collaborative and respectful environment.
  • Influencing: demonstrated skills in persuading senior leadership on strategy, initiative(s) implementation, and decision-making. Influences and motivates others to achieve objectives.

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

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71) Director / Sr. Director CMC Operations – Full Time (San Francisco or Greater Bay Area) BZ155F

DESCRIPTION:

  • Responsible for leading the activities involved in all aspects of drug product development and manufacturing. 
  • Responsible for drug product development and manufacturing for the global product approval and eventual commercialization. 
  • Will provide technical expertise to manage multiple contract manufacturing organizations and third party organizations. 
  • Work closely with the Manufacturing, Validation, Engineering, Quality, and Regulatory Affairs functions internally and at the CMO sites to ensure all aspects of the development, manufacturing, and validation of the drug product. 
  • Work with the CMO sites to ensure that all GMP and Inventory requirements for the drug product are met for the projects. 
  • Responsibilities will include coordinating timelines and deliverables through Program Management as well as writing relevant documentation for regulatory submissions for global registration of products. 
  • Responsible for coordinating with quality the review and audit of drug product vendors and manage external resources such as vendors, consultants or paid advisors.

EXPERIENCE AND QUALIFICATIONS:

  • Advanced degree in either Biological Sciences or Engineering, preferably an MS or PhD, or a B.S. in a Scientific field with at least 15 years of industry experience. 
  • Minimum of 10 years experience in Manufacturing or Development roles with more than 5 years in a drug product development and manufacturing function at a biotechnology or pharmaceutical company with direct involvement in the process to achieve early development milestones and successful product licensure. 
  • Experience in leading or being part of a team through the successful approval of new drugs in the US and/or Europe and/or Japan. 
  • Experience will include leading meetings, teams and CMOs. 
  • Have deep experience with drug product manufacturing issues. 
  • Have had industry involvement in regulatory interactions / filings involving biologics as well as combination products (drug/device) and have strong knowledge of current requirements for GLP, cGMP and GCP. 
  • Forward-thinking and creative with high ethical standards and a team player with leadership skills with ability to influence others to achieve successful regulatory filings and meetings. 
  • Recognized for being well organized and self-directed with strong interpersonal skills with an ability to communicate to people at all levels of an organization.

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

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72) Specialist / Sr. Specialist/Manager – Quality GCP Compliance – Contract or FTE (San Francisco or Greater Bay Area) RA82H

DESCRIPTION:

  • Provides QA support and oversight to clinical activities to ensure compliance with Good Clinical Practice (GCP).  
  • Participate in development of clinical and clinical QA (CQA) Standard Operating Procedures and Policies
  • Manage audits of investigator sites, vendors/CROs, trial master files, data/CRFs and study documents (eg, protocol, clinical study reports) for clinical trials
  • Serve as QA GCP representative at project meetings. 
  • Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
  • The Sr. QA Specialist having a wide-range of experience uses professional concepts and company objectives to resolve complex issues in effective and creative ways.  
  • QA Specialist is a seasoned professional with full understanding of the area of specialization and resolves a wide range of issues in creative ways.
  • Partner with the clinical group to ensure all clinical trials are assessed for compliance with SOPs, FDA and other applicable regulations, and ICH/GCP guidelines.
  • Review other departmental procedures and clinical documents from a GCP compliance perspective and provide supervisor with reports of compliance matters. 
  • Plan and conduct audits, and prepare/issue audit reports including external vendor audits, Trial Master File audits, clinical investigator site audits, document audits, and system audits.  
  • Conduct these duties with little to no supervision.
  • Communicates effectively with professional staff and management across departments on audit findings.  
  • Participates in corporate audits/regulatory authority inspections, project team meetings, and training activities, as required. 
  • Represent QA at meetings, and may participate in communicating compliance perspectives and risks.
  • Assist in resolving compliance issues and assessing impact of any deficits. 
  • Serves as process owner for select GCP Compliance Standard Operating Procedures (SOPs).
  • Stay abreast of current regulatory enforcement trends and regulatory changes.  Assist with feedback and updates as relevant to SOPs, training or policy changes to align with regulatory updates.
  • May travel to perform GCP audits or site visits.
  • Working with the QA team, manage identification of the root cause in clinical and clinical QA processes in order to develop remediation plan and the resolution of the audit finding(s) and/or significant protocol deviation(s)
  • Maintain and track clinical CAPAs and follow-up with stakeholders for CAPA remediation activities to ensure actions are assigned and completed.
  • Assist the QA management team with all other CQA activities.
  • Support during regulatory inspections and provides QA expertise and assistance to other departments as required.
  • Maintain a work environment focused on quality and that fosters respect, open communication, collaboration integration, and teamwork.

EXPERIENCE AND QUALIFICATIONS:

  • Have at least 5 years of progressive experience in the Pharmaceutical and/or Biotechnology industry.  
  • The Sr Specialist will possess 8 years’ related QA experience and the Manager will have 8+ years’ experience with at least 1 years’ supervisory experience.
  • Proven experience in clinical compliance or clinical quality assurance.
  • Knowledge of applicable FDA, EU and ICH regulatory requirements for GCP.
  • Computer skills: Proficient with Word, Excel, Visio, PowerPoint and Adobe Acrobat.
  • Excellent written and oral communication skills.
  • Strong to excellent organizational skills with the ability to effectively prioritize, manage multiple projects and tasks with attention to detail.
  • Must have the ability to proactively resolve issues in a diplomatic, flexible and constructive manner.
  • The ideal candidate is highly ethical, self-motivated and directed; works effectively independently as well as in a team environment.
  • BS/BA degree in a scientific or health-rated field.

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

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73) Manager, Process Engineering – Full Time (San Francisco or Greater Bay Area) A146FV

DESCRIPTION:

  • Leads the development and implementation of automation systems and workflows to support the processing of samples in a clinical diagnostics laboratory environment.  
  • Collaborates within a team of scientists and engineers upon projects to conceptualize, design, develop, and implement solutions designed to optimize the performance and increase the efficiencies of the laboratory processes.
  • Leading engineering and automation team
  • Providing projects leadership and direction, building rapport with end-users, lab supervisors and process owners, and coordinating with cross functional projects teams.  
  • Supervise and lead the automation team on the development and integration of automation solutions
  • Defining and leading systems testing and qualification efforts. 
  • Guide and support the documentation for equipment validation and operating procedures, and ensure successful  implementation in the labs.
  • Additional responsibilities include user training, troubleshooting, optimizing the workflows, and on-going support for the end-users.

EXPERIENCE AND QUALIFICATIONS:

  • Strong project management skills, organizational skills, and written and verbal communication skills are required. 
  • Direct Management experience required 
  • Flexibility and self-initiative required to support several simultaneous projects.
  • Ability to collaborate is required.  
  • Preparing User Requirement and Testing Procedure, Standard Operating Procedures, and related documentations; and overseeing the functional and validation testing, IQ/OQ/PQ.  
  • Biotech, pharmaceutical, lab automation providers, or clinical-laboratory experience is highly desirable.
  • A BS or MS degree in a related scientific or engineering field such as Molecular Biology, Process/Industrial Engineering, and Bio-Medical Engineering, with a minimum of eight to ten years of relevant experience.  
  • Technical proficiency and experience in automation systems development and integration for the life science industry; especially with robotics and liquid handling systems is required.  

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

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74) Clinical Trial Assistant – Full Time (San Francisco or Greater Bay Area) AP82R

DESCRIPTION:

  • Responsible for performing multiple tasks that support clinical trials with duties that include, but not limited to:  assist clinical operations staff with activities related to clinical trials, create and maintain documents and tracking systems, maintain accurate files and filing systems, etc. 
  • Assist the clinical operations team to initiate, conduct, and complete Phase I-IV clinical trial activities. 
  • Provide accurate and up-to-date site information to operations team and cross-functional collaborators as needed.
  • Develop and implement accurate tracking systems, forms, and other relevant documents to support clinical trial studies.
  • Develop and maintain non-clinical supply materials such as study supportive documents, reference manuals (study reference and pharmacy manuals, initial site regulatory binder).
  • Order non-clinical supply materials and generate, maintain tracking of these materials.
  • Request and track investigator payments, as needed. 
  • Work with Clinical Operations and Finance to resolve payment issues. 
  • Creation of studies within the system per SOPs, tracking study specific data, and generate reports.
  • Assist in the distribution of key clinical trial documents (i.e. Investigator Brochures, protocols, informed consents, regulatory submissions).
  • Receive and review regulatory documents from clinical sites.  
  • Maintain effective tracking systems and communication with internal and external customers to ensure updates of appropriate regulatory documents (i.e. 1572s, financial disclosures).
  • Coordinate documentation for clinical study supply releases with investigator sites and ensure that regulatory is provided with appropriate documentation of approved investigator sites which will allow centers to be opened, e.g. IRB/EC approvals.
  • Submit and track essential documents to the Trial Master File (TMF) on an ongoing basis and perform periodic review of TMF and clinical development documents throughout the project life for completeness and accuracy. 
  • Maintain files of clinical trial documents for ongoing projects and assist in the archival of CRO study files and legacy documentation. 
  • Coordinate logistics for study meetings, medical expert meetings, investigator meetings, kick off meetings. 
  • Prepare draft minutes from the various meetings for review and finalization by the study team.
  • Assemble documents and supplies as needed to support monitoring visits.
  • Supports the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork.

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of ICH GCPs and other applicable regulatory requirements.
  • Excellent interpersonal and organizational skills as well as the ability to effectively prioritize tasks.
  • Strong problem-solving skills and ability to work independently as well as work collaboratively in a team-oriented environment.
  • Makes effective use of the resources at hand.
  • Effective oral and written communication skills.  
  • Must be able to communicate effectively with members of other departments and with study site personnel as needed.
  • Proficient with computer applications such as Word, Excel PowerPoint and the ability to learn other applications with appropriate training.
  • A BS degree in life science or nursing with 1 to 2 years’ experience as a clinical trial assistant or study coordinator.  Or, an associate degree or equivalent with 4 years of clinical trial experience; specifically working with regulatory documents, tracking documents or as a clinical trial assistant.

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

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75) CDM Systems Project Manager – Contract Position (San Francisco or Greater Bay Area) RP156B

DESCRIPTION:

  • Will report to the head of Clinical Data Management Systems, a liaison to both Clinical Data Management and/or Information Systems.  
  • Will review final testing scripts; Data management be the testors (testing team); Participate in review of output.
  • Will participate in the development of new and/or existing systems to support business processes.  
  • Expected to play the role project manager and business analyst.
  • Manages the project lifecycle from initiation, planning, execution, control, and close out.
  • Develop and implement project timelines that includes software validation and business process milestones 
  • Provide business sponsors, project team, and management with regular updates regarding project milestones
  • Must be able to identify existing or possible gaps in documentation and process, communicate these gaps in a format and structure appropriate for the intended audience
  • Identify and implement business process solutions
  • Responsible for the creation and/or review of user guides, training material, business process procedures and any other documentation required by the project
  • Responsible for user acceptance testing, defect reporting and resolution
  • Implement business process solutions by creating, delivering and training users on new business process and systems
  • Ensure business processes are stable after a new system implementation (or change) by understanding the impact of the changes on the process

EXPERIENCE AND QUALIFICATIONS:

  • Candidates must have worked in Clinical Operations, Clinical Data Management, or Safety at a Medical Device, Biotech or Pharmaceutical institution. 
  • Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience.
  • 2+ years (Management) Consulting or Business Analysis experience

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

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76) Senior Medical Director / Medical Director, Clinical Development – Full Time (San Francisco or Greater Bay Area) YS139B

DESCRIPTION:

  • Report to the Global VP of Clinical Development and matrix with members of the project team to assist in establishing the clinical development strategy for compounds: from the pre-IND setting to pivotal trials and registration. Aspects of the development strategy include study design, tissue sample collection, input to biomarker strategies, and integration of personalized medicine into the clinical development plan.  
  • Accountable for medical monitoring and patient safety and to provide medical guidance during the design, execution, and reporting of clinical studies and registration with health authorities.
  • Lead the formulation of clinical development plans, including selection of the proof of concept indications for specific projects. 
  • In collaboration with appropriate team members (e.g., clinical pharmacology, statistics, translational medicine, research), be responsible for the design of protocols and conduct of data review, analysis and interpretation.
  • Function in the role of medical monitor.
  • Ensure the medical and scientific quality of clinical trial protocols, case report forms, data and data listings, and clinical trial reports. 
  • Be accountable for safety across relevant studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues.
  • Work closely with CRO, Clinical Operations and investigators/investigative sites to ensure data quality and patient safety.
  • Maintain working knowledge of GCPs and regulatory requirements relating to clinical development and safety compliance with ethical, legal and regulatory standards. 
  • Participate in proposal generation, feasibility assessments, and review of proposals/contracts for medical services.
  • Participate in the development and delivery of protocol training for investigator site and staff.
  • In conjunction with the CMO and Research group, prepare strategy presentations, present and discuss data at relevant team, governance, executive committee, external consultant, KOL, and regulatory meetings.
  • Author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
  • Participate in preparation for and conduct of meetings with healthcare authorities.
  • Contribute to the overall strategy and preparation of documents to secure approval of drug, BLAs/NDAs/MAAs.
  • Lead or assist in preparation of manuscripts, abstracts and meeting presentations.
  • Responsible for the on-time and within-budget execution of protocols.
  • Organize and prepare for Board meetings.
  • Act as clinical representative for out-licensing/collaboration presentations and facilitation of due diligence with prospective partners, and in-licensing activities such as due diligence, report generation, and formulating development strategies.

EXPERIENCE AND QUALIFICATIONS:

  • Requires MD with a minimum of four years of demonstrated knowledge and experience in clinical research, preferably in an industry setting.
  • Strong basic science knowledge to enable proof-of-concept and PD biomarker design and interpretation.
  • Oncology fellowship training and active board certification within the last 5 years.
  • Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences). 
  • Demonstrated scientific productivity (publications, abstracts, etc.).
  • Scientific writing skills and good communication skills.
  • Flexibility to work with colleagues in a matrixed setting.
  • Able to engage in work-related travel approximately 20%.

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

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77) Regulatory Project Manager 1 – Full Time (San Francisco or Greater Bay Area) DY113R

DESCRIPTION:


  • Manage regulatory team operations, including facilitation of team and strategy meetings (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership often required).
  • Create and maintain regulatory timelines and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies; create and maintain reporting dashboards for teams and management.
  • Track submission preparation progress, including but not limited to post-marketing and annual reporting commitments, to ensure timely filing to health authorities.
  • Document project milestones/deliverables and report progress against team, department, and corporate goals.
  • Facilitate short and long-term planning activities.
  • Analyze internal Regulatory Affairs and Project Management processes, identify opportunities for improvement.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with MS Project 2010, or similar scheduling software, required or proven skill at adapting to new software/technology.  
  • MS Project Server experience helpful.
  • Pharma/biotech or related industry experience required.
  • Excellent interpersonal skills; adept at working as a part of an interdisciplinary team and skilled at negotiation and influencing others.
  • Knowledge of regulatory affairs submissions and nomenclature desirable.
  • Exposure to electronic document management system(s) (EDMS) helpful.
  • Bachelor’s degree required.
  • Project Management Professional and/or Regulatory Affairs Certification a plus.
  • At least 5 years’ experience in a project management or scheduling environment
  • Minimum of two years’ experience managing teams and team operations.

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

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78) (Senior) Manager, Regulatory Operations – Full Time (San Francisco or Greater Bay Area) JN113W

DESCRIPTION:

  • Oversee planning, scheduling, resource allocation, formatting, publishing (including QA), transmitting and archiving regulatory submissions in both paper and electronic media to health authorities in the US, EU, etc. 
  • Manage internal regulatory operations personnel as well as the activities of external consultants. 
  • Oversee the development and maintenance of processes, templates, standards, and guide sheets. 
  • Must be able to oversee applications and systems support (Livelink Knowledge Management), systems training programs, and supporting development projects within Regulatory Affairs. 
  • Other duties as assigned.
  • Interacts with regulatory affairs providing information to be submitted (including but not limited to Clinical, Nonclinical, and Quality).  
  • Requires the ability to exercise discretion, independent judgment and clearly identify priorities, as well as to work overtime in order to meet required timelines.

EXPERIENCE AND QUALIFICATIONS:

  • A minimum of 3- 5 years of experience in regulatory operations
  • A minimum of 2 years experience as a Manager with direct reports with no more than 5 years gap since having had direct reports
  • Must be highly proficient in MS Office 2007,MS Word, and Adobe Acrobat (version 5.0 or above preferred).
  • Experience with a publishing tool; Knowledge of Livelink and InSight Publisher preferred. 
  • Must have experience with electronic submissions, specifically eCTD.
  • The candidate should have proven ability to manage critical projects as part of an interdisciplinary team. 
  • Experience managing major regulatory submissions, with the ability to successfully manage projects to deadlines.
  • The candidate is expected to have a thorough understanding of relevant submission formatting, transmittal and archiving regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.
  • Bachelor’s Degree desirable.

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

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79) CDM Systems Project Manager – Contract Position (San Francisco or Greater Bay Area) RP156B

DESCRIPTION:

  • Will report to the head of Clinical Data Management Systems, a liaison to both Clinical Data Management and/or Information Systems.  
  • Will participate in the development of new and/or existing systems to support business processes.  
  • This position will be expected to play the role project manager and business analyst.
  • Manages the project lifecycle from initiation, planning, execution, control, and close out.
  • Develop and implement project timelines that includes software validation and business process milestones 
  • Provide business sponsors, project team,  and management with regular updates regarding project milestones
  • Must be able to identify existing or possible gaps in documentation and process, communicate these gaps in a format and structure appropriate for the intended audience
  • Identify and implement business process solutions
  • Responsible for the creation and/or review of user guides, training material, business process procedures and any other documentation required by the project
  • Responsible for user acceptance testing, defect reporting and resolution
  • Implement business process solutions by creating, delivering and training users on new business process and systems
  • Ensure business processes are stable after a new system implementation (or change) by understanding the impact of the changes on the process

EXPERIENCE AND QUALIFICATIONS:

  • Candidates must have worked in Clinical Operations, Clinical Data Management, or Safety at a Medical Device, Biotech or Pharmaceutical institution. 
  • Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience.
  • 2+ years (Management) Consulting or Business Analysis experience

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

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80) Director QA, GxP Quality Systems – Full Time (San Francisco or Greater Bay Area) F110JV

DESCRIPTION:

  • Responsible for developing and implementing GxP Quality Systems for drug/device combination products. 
  • Manage and/or through direct reports all aspects of GxP Quality functions through all phases of product development, clinical, commercial and life-cycle.
  • Serve as the key point of contact representing QA in various projects and liaising with various regulatory agencies for quality related matters.  
  • Provide strategic leadership, development and implementation of GxP QA Systems for drug/device combination aseptic products.
  • Develop and maintain a compliant Quality Management System to comply with applicable company, US and worldwide regulatory requirements including standards, guidance and procedures. 
  • Oversee and manage all aspects of quality functions for design review, Deviations and CAPA, Document and Change Control, Management and Product Quality Review Product Complaints, Risk Management and Failure  Analysis, Stability, Training and Validation (facilities, equipment, computer systems and processes).
  • Conduct periodic Product Quality and Management Review, including tracking, trending QA metrics and design action plans to address trends.
  • Identify, assess and communicate QA strategies, metrics, gaps and compliance risks to senior management.
  • Partner with Product Development, Regulatory Affairs, Clinical Research, external vendors and partners to support corporate objectives and ensure that the site complies with all quality, regulatory and compliance requirements.
  • Contribute to site PAI and commercial readiness preparations.  
  • Host and manage all regulatory audits; Federal, Notified Body for CE Mark, State including partner audits.
  • Oversee Supplier Qualification Program and ensure quality agreements are in place for key vendors and compliance to approved agreements.
  • Provide guidance on regulatory standards for compliance with CE Mark Technical Files/Dossiers.
  • Develop a high performing team to manage GxP QA responsibilities.  
  • Hold the team accountable for preparing and achievable tactical goals.
  • Prepare accurate budget and headcount forecasts for QA organization.
  • Oversee the QA organization within allotted budget and headcount.  
  • Provide training, development and growth opportunities for employees.

EXPERIENCE AND QUALIFICATIONS:

  • A minimum Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred.
  • Seasoned professional in managing GxP Quality Systems (QA and QC) for drug/device combination aseptic products with a thorough knowledge of cGMP regulations (21CFR211, 21CFR820, EMA), ISO 13485, CE Marking and ICH guidance’s
  • Experience in oversight of implementing GxP computer systems with compliance to Part 11 and EU Annex 11 requirements.
  • Working knowledge of ICH risk management tools, Failure Mode Effects Analysis (FMEA), and/or lean/Six sigma concepts.
  • A minimum experience of 15+ years in the drug/device pharmaceutical and biopharmaceutical industry with multiple areas of functional and technical expertise. 
  • Proven track record with a strong knowledge of aseptic processing.
  • A minimum of 8 years in QA management managing GxP functions either in small and/or big pharma with attention to details
  • Ability to work independently on QA projects and initiatives with minimum supervision
  • Pro-active and identifying opportunities along with strong problem solving and negotiation skills.
  • Ability to work "hands on" in an entrepreneurial, fast paced environment. 
  • Leads by example and highly collaborative with the proven ability to work in a cross-functional team.
  • Self-starter and team player with strong leadership, administrative, interpersonal, and team-building skills.
  • Strong verbal, written communication skills and computer skills are required.
  • Must be goal-oriented, quality-conscientious, and customer-focused.

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

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81) Chief Medical Officer – Full Time (San Francisco or Greater Bay Area) TG155B

DESCRIPTION:

  • Participate in long-range strategic planning for products in development.
  • Establish and approve scientific methods for design and implementation of clinical protocols.
  • Adverse event safety monitoring and reporting.
  • Develop study protocols in collaboration with the clinical operations department.
  • Recruit and motivate clinical investigators.
  • Presentation of technical information to internal and external personnel.
  • Contributes to Clinical Study Reports, IND Submissions and other clinical/regulatory/safety documents.
  • Manage external presentation of data (e.g. publications, scientific meetings).
  • Represent clinical research as a member of trial teams.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with IND submissions and starting first in man trials preferred
  • Minimum 5 years’ experience in clinical trials is preferred, either within an academic environment or within the biopharmaceutical industry.
  • Ability to effectively participate in multi-disciplinary teams.
  • Excellent presentation skills
  • Proven organizational skills; ability to manage multiple priorities and work under pressure
  • Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials, specifically
  • Requires an M.D. or equivalent, Neurology specialty preferred and CNS clinical trial experience required

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

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82) Executive Human Resources Coordinator – Full Time (San Francisco Bay Area)

DESCRIPTION:

  • Provide advanced assistance to company executives by performing various complex administrative support functions, typically of a confidential nature. 
  • Transcribe information of a technical, confidential and/or sensitive nature
  • May be required to take meeting and/or conference call minutes. 
  • Collects and prepares information for use in discussions/meetings of executive staff and outside individuals. 
  • Maintains company electronic files
  • May collect employee timesheets and input into Payroll system for processing
  • Set up and confirm candidate interviews with clients
  • Post job advertisements
  • May find and submit qualified candidates for open positions in the client facilities/ help with recruiting. 
  • Conduct Onboarding and Outboarding of employees
  • Respond to EDD / government agency inquiries

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree strongly preferred -- BS/BA in Biology or Life Science preferred; Associate degree acceptable if  >8 years previous experience as an executive AA in the pharmaceutical or medical device industry
  • Ability to handle a large variety of details and to work with all levels of organization
  • Ability to handle sensitive confidential data
  • Excellent customer service skills and interpersonal skills 
  • Excellent oral and written communication skills
  • Self starter who quickly absorbs new information and is able to act on newly learned tasks with little supervision
  • Proficiency with use of Outlook, Microsoft Office, SharePoint and the ability to easily learn new software.    
  • Minimum of 5 years of progressive office experience as a Sr. Administrative Assistant or HR Coordinator.
  • Excellent computer skills: Applicant tracking systems; database experience, Microsoft Word, Excel, and Outlook
  • 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.

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

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83) (Senior) Clinical Document Assistant – Full Time or Contract (San Francisco or Greater Bay Area) FH82P

DESCRIPTION:

  • Responsible for creating and maintaining accurate Trial Master Files (TMF) for all clinical studies.  
  • Duties will include but not limited to maintenance and QC of TMF, functional and orderly Clinical Document Room, and reporting TMF status to clinical operations. 
  • Responsible for the TMF inventory across multiple studies:
  • Create and maintain TMFs.
  • Receive in documents and QC TMF documents for accuracy & completeness.
  • Review the transfer information of all documents submitted to the system.
  • Accurate and consistent filling of essential documents in TMF.
  • Participate in file reconciliation and quality control checks.
  • Maintain accurate and up-to-date tracking systems, forms, logs, binders and other relevant documents to support essential document management.
  • Provide accurate and up-to-date essential document status as it relates to TMFs.
  • Collaborate and communicate closely with cross-functional teams as a TMF repository advisor.
  • Assist in the archiving of clinical study files when required.
  • Business Administrator for TMF MasterControl
  • Responsible for administering security privileges with MasterControl for Clinical staff – these privileges include managing routes, organizers, documents and controlled copies, for all TMF Infocard and SubInfocard types.
  • Create TMF InfoCard, TMF document attachment, QC and verification.
  • Responsible for Clinical employees’ training records.  Perform regular audits to ensure training files are accurate and complete.
  • Coordinate and track MasterControl training required for clinical.
  • Perform TMF based information and metrics collection as well as status updates, as requested.
  • Ensures document room is functional and orderly at all times.

EXPERIENCE AND QUALIFICATIONS:

  • A degree in life sciences or equalivant experience or previous experience working with Clinical Trial Document; TMF

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

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84) Director, Clinical Operations – Full Time (San Francisco or Greater Bay Area) B151GQ

DESCRIPTION:

  • Lead clinical trial teams and oversee the management of all operational aspects of clinical study conduct from selection and qualification of vendors and investigational sites through finalization of clinical study reports. 
  • Will report to the Senior Director, Clinical Operations.
  • Collaborates with cross-functional teams to design and develop clinical study protocols in line with business needs
  • Develops and manages study timelines, milestones and budgets
  • Develops study management plans and forecast study resourcing
  • Selects and leads clinical trial teams
  • Development of study protocols, case report forms, informed consent forms and other study-related documents
  • Selection, management and oversight of CROs to ensure that clinical studies are executed properly and in compliance with GCPs
  • Review and qualification of investigational sites
  • Management of clinical study monitoring
  • Collection and archival of all documents for inclusion in the Trial Master Files
  • Review and finalization of clinical study report
  • Identify quality initiatives prior to study start and manage initiatives throughout the study; implement appropriate corrective action plans.
  • Serve as primary project contact, or as escalation contact, internally, and with any CRO to ensure high level of communication and partnership is maintained and timelines are effectively met.
  • Manage the development or develop/update clinical SOPs in accordance with ICH and GCP guidelines.
  • Directly manage and mentor/develop staff to ensure high quality team results.

EXPERIENCE AND QUALIFICATIONS:

  • Strong written and verbal communication, interpersonal, problem solving and negotiation skills
  • Excellent presentation skills
  • Ability to present to diverse groups of clinical staff (internal and external) 
  • Proven organizational skills
  • Ability to manage multiple priorities and work under pressure
  • Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials, specifically, knowledge of 21 Code of Federal Regulations Title 21 Parts 11, 50, 54, 56, 312, 314; International Conference on Harmonization Guidelines E6 (Good Clinical Practice: Consolidated Guidance), E2A, E8 and Guidelines from other Regulatory Authorities pertinent to planned studies
  • Knowledge of computer software: Microsoft Word, Excel, PowerPoint, Project, and Visio
  • Ability to travel
  • Strong leadership skills to present to Senior Management 
  • At least 5 years of experience managing staff and selecting/hiring team members.
  • CNS experience is preferred and international study experience is a plus.
  • Bachelor's degree in life sciences or related field and 10 plus years of clinical management experience in a combination of pharmaceutical, biotechnology and CRO industries.

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

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85) Sr Programmer / Principal Dataset Statistical Programmer – Full Time (Boston Area) GP153F

DESCRIPTION:

  • This is a leadership role able to lead and direct project work.  
  • Create input data files for NONMEM software which is used to conduct a population PK or population PK / PD (Phamocometrics) analysis using UNIX SAS software to develop a program based on provided programming specifications.
  • Program and plan the integration of databases from multiple studies or sources.
  • Lead or assist in the application of computer science and information technology methods to provide the technical components that support all aspects of pharmacology clinical development process, including clinical development plans and scientific utilization data. 
  • Provide strategic input and leadership to the delivery of all technical programming and information components of deliverables.
  • Oversee the quality of all deliverables, holding partners and providers accountable for the quality of their deliverable
  • Lead programming support for deliverables to the regulatory submissions including delivery of NONMEM data.
  • Identify opportunities to improve the methodology and provide practical solutions for problems 
  • Contribute to the development of best practice to improve quality, efficiency and effectiveness

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of CDASH/SDTM/ADaM CDISC standards
  • Experience of Regulatory submissions preferred
  • Excellent communication and collaboration skills.  
  • Will work across global & functional boundaries 
  • Ability to apply programming expertise to problems, problem solving and quality focus
  • Agile responsiveness to scientific data
  • Other programming languages e.g. S-PLUS, R etc.
  • Computer technical background a plus (Linux, high performance cluster)
  • Data management background a plus (clean data for analysis)
  • Experience with Pharmacometrics (Pharmacokinetics PK / Pharmacodynamics PD) data a plus
  • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data. 
  • Ability to work effectively on multiple tasks or projects.
  • BSc in Mathematical, Statistical, Computer Science or Life Science
  • Extensive SAS programming expertise to an advanced level.  2 years generating NONMEM datasets preferred

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

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86) Director Project Manager – Contract (10 to 15 hrs/wk long term) (San Francisco or Greater Bay Area) GB152Y

DESCRIPTION:

  • Responsible for project management of all aspects of product development for IND submissions and clinical trials
  • Manages team to execute all project deliverables; leads cross-functional core team and vendors.
  • Coordinates, synchronizes and manages overall project schedule.  
  • Accountable for execution on project timelines.
  • Identify appropriate resources needed and develop schedule to ensure timely completion of project
  • Regularly track and communicate project status to all stakeholders
  • Schedule and facilitate all necessary meetings associated with product development
  • Assess, communicate and manage risk
  • Facilitates identification and mitigation of program risks.  
  • Highlights business implications of identified risks
  • Acts as information conduit between the team, vendors, and senior management, prepares and presents reviews

EXPERIENCE AND QUALIFICATIONS:

  • Experience with IND submission
  • Experience with Phase 1 / 2 clinical trials
  • Experience with budgets, Microsoft Project timelines, and meeting minutes/ agendas
  • Works on complex, multi-faceted problems where analysis may require in depth analysis
  • Solves problems in imaginative and practical manner
  • Able to make decisions that impact project timeline, budget, strategic fit and viability to business.
  • Interacts and connects with core and extended team members most of which are consultants or contracted vendor organizations
  • Able to influence others or gain acceptance in sensitive situations
  • Minimum of Bachelor's degree (B. S.), preferred in the Life Sciences
  • 10 or more years of combined drug product development and project management experience

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

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87) CTM / Sr. CTM, Oncology or Pulmonary – Full Time (San Francisco or Greater Bay Area) JM82P

DESCRIPTION:

  • Manage and lead all aspects of one or more oncology and pulmonary Phase 1 to 4 clinical trials including, but not limited to protocol development to final report, clinical operations support for trial start-up, conduct, and close-out activities in order to achieve program objectives and goals.  
  • Collaborate with clinical contracts/budget to manage efforts for clinical service provider selection. 
  • Lead clinical trial project execution for oncology and pulmonary programs to ensure that trial timelines, costs, and quality metrics are met.
  • Serves as primary contact for functional area representatives in managing protocol execution.
  • Manage the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments.
  • Forecast and oversee clinical supplies
  • Manage study milestones to ensure accurate tracking and reporting of study metrics.
  • Oversee ongoing service provider management (e.g., CROs, IVRS), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
  • Create and manage clinical trial budgets in collaboration with the Vice President of Clinical Operations.
  • Provide study-specific direction and mentoring to CRAs and CTAs. 
  • Collaborate with clinical QA to maintain quality standards in compliance with regulatory requirements/guidance’s and adherence to SOPs and ICH/GCPs; participate in ongoing process improvement initiatives.
  • Manage adherence to ICH/GCP/local regulations.
  • Participate in clinical operations initiatives and programs.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.


EXPERIENCE AND QUALIFICATIONS:

  • Broad and current knowledge of regulations, clinical development process and oncology and pulomary.
  • 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 includes Word, Excel, PowerPoint, and Outlook.
  • Working knowledge of MS Project for development and update of clinical study timelines. 
  • Willing to travel up to 25%.
  • Bachelor’s Degree with at least 5 years of CRA experience for the manager level.  
  • Requires 8+ years of combined CRA and CTM experience.  
  • At least 2 years direct staff management experience is required.

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

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88) Clinical Program Manager – Full Time or Contract to Full Time (San Francisco or Greater Bay Area) G121PA

DESCRIPTION:

  • Responsible for the daily management of Phase I-III clinical studies. 
  • Ensuring that clinical programs are executed with compliance to clinical practices and the study protocol, and that studies are developed and managed on time and within budget. 
  • May be responsible for the management of one or more clinical trials, and may act as program team leader or member while also serving as a resource to the clinical department and the company to achieve our clinical research objectives.
  • Manage the day-to-day clinical operations of the clinical trial/program
  • Participates in CRO and vendor selection process for assigned clinical programs
  • Manage CRO(s), clinical vendors, and team members throughout clinical study lifecycle
  • Oversees clinical site identification, training and initiation, monitoring, and closeout
  • Reviews and refines clinical study and vendor plans
  • Leads study data review for quality and consistency to study objectives
  • Manages study timelines, budget, and resource allocation
  • Oversees submission of trial-related documents into the trial master file
  • Maintains effective relationships with clinical collaborators and clinical site personnel
  • Collaborates with Medical, Regulatory Affairs, Quality, Research & Development, and other Clinical Research personnel
  • Analyzes information, and utilizes prior clinical experience and problem solving skills to ensure the best possible outcome of the clinical research program
  • Attends or leads cross-departmental project team meetings, which includes preparation of meeting agendas, and timely and accurate communication of team meeting decision and action items
  • Reviews and reconciles financial aspects of study (e.g., invoice and payment tracking)
  • Assists in providing cross-functional program operation plans and cost estimates
  • Provides routine updates on clinical study and/or program milestones
  • Provides clinical study and/or program status reports on a timely basis to the project team and senior management
  • Mentors staff and acts as a clinical resource for new employees
  • Position may include up to 20% domestic and/or international travel
  • Other duties as assigned

EXPERIENCE AND QUALIFICATIONS:

  • Thorough knowledge of ICH/GCP guidelines, FDA requirements for INDs, NDAs, and drug approval process
  • Excellent analytical, negotiation, and problem-solving skills
  • Outstanding organizational, communication, and presentation skills
  • Thorough understanding of cross-functional clinical processes including data management, drug safety, biostatistics, and medical writing
  • Strong influencing skills are required to manage clinical site personnel
  • Exhibited ability to be proactive and agile in a fluid clinical study environment
  • Must be candid and transparent when reporting status and alerts to the clinical team, clinical management and senior management of the company in a full-disclosure and proactive manner
  • Candidates must be experienced with a proven track record in a clinical research management, high-energy, able to function in a growing, dynamic environment and able to multi-task and communicate at all levels within the organization
  • Bachelor’s degree in a scientific field or equivalent and 7+ years of clinical experience
  • 5+ years direct experience managing clinical studies, including field monitoring experience

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

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89) Project Team Leader/ Sr Director – Full Time (San Francisco or Greater Bay Area) RY151F

DESCRIPTION:

  • The project team leader will be instrumental supporting company growth in providing expertise to manage the development drug candidates into therapeutics that can be filed, approved by regulatory agencies and successfully commercialized on a global basis. 
  • Will play a key strategic role through the lifetime of project, transitioning the drug candidate out of research into clinical development and taking it through to launch and lifecycle management.
  • Responsible and accountable for leading one or more project teams. 
  • The project team leader will ensure that optimal development strategies that align to corporate objectives and to the strategic plan for the therapeutic area are in place and executed to agreed time, quality and budget objectives. 
  • Responsible for generating a product life cycle plan to deliver maximum value throughout the life of the product.
  • This is a Senior Director position reporting to the vice president of management.
  • Lead global, cross-functional project development teams to develop strategic plans and to ensure execution of the development plans for each of the drug candidates (from concept through marketing and life cycle management).
  • Work closely with team to create innovative target product profiles and product development plans that optimize value, time, resources and risk while ensuring that project strategy is aligned with business objectives.
  • Partner with cross-functional team members, including Project Manager, Research, Clinical, Non-Clinical, Regulatory Affairs, CMC and Finance to ensure that projects have adequate resources and technical expertise to meet strategic objectives.
  • Identify issues and risks and lead contingency planning.
  • Ensure adherence of project plan and activities to agreed time, resource, budget and scope.
  • Accountable for product development documentation (integrated project plans, etc.).
  • Drive decision-making  and ensuring conflict resolution at product development level.
  • Present strategic issues, project plans, options and recommendations to senior management.
  • Communicate project information to senior management and key stakeholders.
  • Maintain commercial, scientific and regulatory awareness to ensure that project plans reflect latest scientific/medical developments and regulatory/commercial environment.

EXPERIENCE AND QUALIFICATIONS:

  • Previous experience as a project team leader is a plus. 
  • NDA experience is required; Launch experience is desired.
  • In-depth knowledge and experience of the global drug development and commercialization process.
  • Proven management and/or leadership experience in an R&D or commercial context within pharma and/or biotech and successful track record managing development projects.
  • Experience in more than one therapeutic areas preferred.
  • Strategic thinker with excellent problem solving skills and an ability to influence all levels of the company.
  • Ability to achieve results in a matrix management organization, across different sites and with colleagues of diverse functional expertise, skills and priorities. This would include the ability to challenge the status quo where relevant, and to resolve conflict within the team while maintaining clear focus on business objectives.
  • Ability to drive, anticipate, influence and implement change.
  • Ability to be effective as a team player as well as a team leader, exhibiting excellent listening and collaboration skills.
  • Excellent communication, writing, planning and tracking skills.
  • Bachelor’s degree in a scientific, medical or business discipline. 
  • An additional/post-graduate qualification is an advantage (PhD, MBA etc.); minimum of 12 years of experience in management/leadership roles in pharm and/or biotech.

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

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90) CTM / Senior CTM – Full Time (San Francisco or Greater Bay Area) GA139X

DESCRIPTION:

Seeking a highly motivated individual to join the Clinical Operations group. This individual will play a key role in assisting the 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, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. We are 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.

Responsibilities:
  • Responsible for the successful planning and execution of clinical studies to ensure that trials are conducted on time, on budget, and in compliance will the protocol, all applicable regulations and SOPs. Uses thorough knowledge of FDA regulations and ICH guidelines to ensure compliance with both of these during clinical trial planning, conduct, and close-out; develops monitoring plans, tracking tools and other mechanisms to ensure that trial is conducted according to plan
  • Works with supervisor to lead the management team in the development of study-specific documentation, including protocols, CRFs, subject consent forms, study reference manuals, etc; may author some or some portions of these documents
  • Assists in the development of outsourcing plans for external vendors – develop and facilitate RFPs, review proposals and make award recommendations, select and manage vendors to ensure that project goals are achieved
  • Assists with the day-to-day management of CROs and sites in the conduct of one or more clinical studies; organizes and leads teleconferences with key CRO personnel, facilitates CRO activities and adherence to scope of work and service agreement
  • Establishes relationships with Investigators and other key site personnel as well as CROs and key CRO personnel; may serve as primary point of contact for US CRAs or specific CRO personnel
  • Participates in department process improvement initiatives – may review and revise SOPs, working practices and other infrastructure as directed; assist in the creation and improvement of department infrastructure to ensure that studies are conducted in compliance with GCP and CFR and that all essential documentation is collected, maintained, archived and inspection ready
  • Performs monitoring or co-monitoring of clinical sites as required by the needs of the project, and with minimal guidance from supervisor; develops and oversees study quality metrics to ensure that subject recruitment goals are met
  • Works with supervisor, external partners and sites to ensure that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled and otherwise ‘quality assured’;  provide input for the design of CRFs, monitoring conventions, edit checks, etc.
  • Assists in the development of clinical trial budgets; monitors activities at sites and vendors to ensure compliance with budget; supports efforts to revise budget forecast as needed; develops and maintains study budget tracking tools to ensure that trial costs are accurately tracked and reported to finance
  • Partners with and supports MD's and other scientific leaders to ensure that scientific objectives of the clinical studies are met; provides reports, metrics and other information for analysis and interpretation as needed; may take part in advisory meetings, investigator meetings and other study-specific scientific venues in order to support scientific objectives
  • Participates in the ongoing and final review of clinical study data and assessment of the impact of this data to the study and program. May author some sections of clinical study protocols, consent forms, manuals, study reports, annual reports and other clinical documents

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree in science or health-related field required
  • Minimum of 5-7 years of clinical trial management experience, with a minimum of 3-5 years of trial management experience in Pharmaceutical or Biotech company required; early-phase trial management preferred
  • Oncology or Immunology required.
  • Thorough and proven knowledge of GCP, CFR and ICH guidelines;  Proven track record for delivering clinical projects within time, budget and quality expectations; global clinical trials experience highly desirable
  • Strong written and oral communication skills; proficiency in MS office including Word, XL, Powerpoint and other applications; demonstrated experience in technical writing
  • Highly-motivated, accountable, and able to perform work independently with minimal supervision and with a sense of urgency;
  • Exceptional interpersonal skills, team-oriented approach, collaborative, flexible and eager to contribute in a sometimes resource-constrained setting;
  • Able to travel up to 35% 

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

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91) Associate Director / Director of Quality Assurance – Full Time or Consultant (San Francisco or Greater Bay Area) P150WB

DESCRIPTION:

  • Maintain and establish documented company-wide quality system in full compliance with ISO 13485 and FDA QSR
  • Manage the QA, quality engineering, and document control functions. 
  • Direct interactions with FDA, notified state department of health related to company inspections. 
  • Hire, train, and manage quality engineers, quality technicians/inspectors and document control personnel. 
  • Provide directly, or through subordinates, active quality engineering participation on project team during the development process.
  • Establish and direct the employee QSR and ISO training program. 
  • Establish and oversee environmental controls program. 
  • Provide support and guidance to sterilization validation, biocompatibility programs. 
  • With manufacturing management, establish and oversee supplier audits. 
  • Establish and direct completion of regularly scheduled internal audits. 
  • Review and approve all product labeling and marketing materials to ensure compliance with regulatory requirements.
  • Ensure that accurate and complete records of company-wide activities are generated, properly secured, and that they meet regulatory requirements.
  • Serve as designated management representative for the company during management review, regularly present to quality senior staff on related issues. 
  • Manage vigilance/medical device reporting and complaint management activities. 
  • Initiate and chair Complaint Review Committee as required. 
  • Develop, implement and supervise the non-conformance (NCR) and CAPA systems. 
  • Initiate and chair material review board (MRB) as required. 
  • Ensure calibration system for all inspection, production and R&D instruments is established and maintained. 
  • Provide quality system awareness training to employees as required. 
  • Proactively develop and support company goals and objectives, policies and procedures, GMP and FDA, and MOD
  • Maintain a professional, credible image with consultants, suppliers, and co-workers. 
  • Perform other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • ASQC Certificate in quality engineering or quality management. 
  • Minimum of seven years related experience, preferably in the medical device field
  • At least 3 years management/supervisory experience. 
  • Good interpersonal, supervisory and training skills. 
  • Ability to work independently and resolve issues. 
  • Computer literacy in Word, Excel, and PowerPoint required. 
  • Comprehensive knowledge of and intimate familiarity with the requirements of current versions of ISO 13485 and FDA QSR
  • BSME (or related discipline).

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

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92) Senior Director – Project Team Leader – Full Time (San Francisco or Greater Bay Area) A139JX

DESCRIPTION:

Reporting to the CMO, the Project Team Leader (PTL) will be responsible for leading development of therapeutics from pre-IND to Phase III. The PTL will provide direction and leadership to the cross-functional project team including scientific oversight of activities, budget and planning; and partner with stakeholders to develop project vision, strategy, scope, milestones, risk assessment, valuation and project investment requirements. Typical project teams include representation from research, nonclinical & clinical clinical pharmacology, regulatory affairs, commercial, finance and CMC. Utilize deep understanding of drug development and commercialization to effectively lead teams and to drive strategic decisions. 

Responsibilities

  • Plan and execute product development projects. 
  • Plan and direct schedules and monitors budget/spending. 
  • Ensures consistent practices throughout all phases of the project life cycle. 
  • Drives the development and manages the execution of high quality, integrated cross-functional plans for projects. 
  • Applies project management best practices in the development, initiation, planning, execution, control and closing of projects. 
  • Provides clear direction on product development requirements to meet expectations of external customers and business stakeholders. 
  • Interacts with research and development, marketing, manufacturing, and regulatory departments and with external stakeholders. 
  • Responsible for project performance, risk management, administration, financial management and issue resolution for functional group. 
  • Selects, develops and evaluates personnel to ensure the efficient operation of the function.

EXPERIENCE AND QUALIFICATIONS:


  • Experience leading teams in a matrix environment and demonstrated skills in motivation of teams is required. 
  • Candidate must possess a strong ability to cultivate excellent cross-functional collaborations.
  • Strong decision-making and analytical skills are required.
  • Excellent communication and influencing skills with a proven ability to work with executive management are critical to the success of the role.
  • Will be a dynamic and innovative leader with a well-developed sense of teamwork and have the interpersonal skills required to communicate effectively with external collaborators and internal stakeholders. 
  • The individual will also be a well-respected mentor through coaching, respect, honesty, humanity and daily practice of lead-by-example. 
  • Successful colleagues can manage successfully, and can develop and execute project plans within a busy environment.
  • At least 10 years of industry experience in drug development, including experience in early phase non-clinical and clinical drug development and regulatory knowledge
  • The successful candidate will ideally have an advanced degree in life sciences or medicine (MD or PhD) and/or an MBA.  

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

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93) Clinical Program Manager – Full Time (San Francisco or Greater Bay Area) G149PR

DESCRIPTION:

  • Provide leadership to a multi-functional study team in order to ensure that assigned clinical trials are executed on time, on budget, and in compliance with GCP and other applicable guidelines and regulations. 
  • Contribute to the development of clinical operations department processes and procedures and may also be responsible for hiring, development and performance management of direct reports.  
  • Directs a multi-functional study team in the day-to-day execution of clinical trials
  • Partners with clinical operations management and project management to define study milestones and deliverables and executes to ensure timelines, budget and quality are met.
  • Actively participates in CRO, site and vendor selection in order to ensure that trial responsibilities are appropriately delegated and that partners are aligned with corporate objectives; provides ongoing surveillance of progress and ensures that contingency plans are triggered as and where appropriate
  • Provides mentorship, supervision and training to other staff assigned to the study, which may include direct and indirect reports and contract monitors.
  • In collaboration with the medical monitor and other personnel, may lead the planning and execution of successful investigator meetings.
  • Works to resolve day-to-day issues in the timely on boarding and initiation of clinical sites, and challenges in the efficient enrollment of study subjects; monitors and reports on the progress of site initiation and subject recruitment.
  • Supervises site monitoring, reviews monitoring reports and metrics, and participates in site auditing to ensure that these tasks are performed reliably and in compliance with applicable regulations
  • Ensures that the study team is up-to-date on current program status and priorities and ensures the goals/objectives are aligned with the corporate goals
  • Develops and refines monitoring plans as well as lab and pharmacy manuals, training manuals, and other procedural manuals as needed to ensure that the trial is conducted consistently across countries and sites.
  • Oversees biometrics vendors, partners with external service providers to develop data management plans, edit check specifications, and analysis specifications
  • Develops expertise and understanding specific to the assigned therapeutic area(s) and builds upon information from previous trials to better the conduct of current and future studies; ensures that program-wide structure and long-term implications are taken into consideration when operational decisions are made (for example design,databases and coding dictionaries) – pro-actively works with supervisor to anticipate long-term implications of such decisions.
  • Provides regular status reports and metric updates of studies to senior management and to project management; works with other personnel to identify risks within studies and proactively plans mitigation strategies
  • Participates in internal/external audits of vendors/sites; works pro-actively to identify compliance risks and partners with team members to trigger preventive or corrective actions where appropriate
  • Works closely with the medical monitor regarding safety reporting and interacts with CRO personnel to ensure timely and accurate delivery of data for safety monitoring committees.
  • Leads departmental or interdepartmental infrastructure and process improvement initiatives where assigned; partners effectively with supervisor to build and continually improve department infrastructure.
  • Assists with the writing of clinical protocols, investigator brochures and annual IND reports where required; reviews and contributes content to these documents to ensure their accurate description of trial status and study subject events.
  • May travel 

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree in a scientific field and 7+ years of clinical trial experience, including at least 4 years of independent trial management experience in a sponsor company
  • Must have independent site monitoring and management experience, and demonstrated track record of increasing levels of responsibility in complex clinical trial management
  • Direct supervisory experience with multiple direct reports strongly preferred
  • Broad knowledge of clinical drug development processes, industry standards, GCPs, clinical trials monitoring, regulatory compliance and an understanding of clinical data management and statistical reporting
  • Thorough knowledge of ICH/GCP guidelines as well as 21 CFR and other applicable regulations.
  • Proven organizational skills with ability to manage multiple urgent priorities in parallel
  • Established leadership and influence skills – able to adapt to different environments and circumstances and to influence and effectively motivate internal and external team members.
  • Excellent analytical, negotiation and problem-solving skills
  • Flexible, adaptable, and able to react to changing circumstances and priorities
  • Outstanding interpersonal and communication skills – able to articulate complex issues effectively in person, and in writing; diplomatic when interacting with multiple internal and external customers.
  • Displays a high level of commitment and professionalism in all environments; leads by example

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

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94) Statistical Programmer Manager / Associate Director – Full Time (San Francisco or Greater Bay Area) MG140P

DESCRIPTION:

Serves as a lead programmer for assigned clinical study projects and is held accountable for all expected deliverables. Responsible for the development, validation, execution, maintenance, documentation, and archival of analysis datasets and programming code used in the analysis of clinical trial data targeted for regulatory submission. All programming must be consistent with good programming practice and compliant with regulatory requirements. Work interactively with biostatistics, data management, clinical and regulatory personnel and other departments as appropriate. Interact with outside groups, e.g., Data Management CROs and EDC vendors.

Responsibilities:
  • Act as a lead programmer for assigned projects/studies
  • Reports to Director Statistical Programming
  • Understand and be accountable for project deliverables
  • Attend project study team meetings
  • Review CRF, data management plan, statistical analysis plan, and other documents as appropriate (e.g. data transfer specifications with vendors)
  • Review and provide feedback on data provided by vendors
  • Develop analysis file specification
  • Assign tasks to other programmers
  • Track programming status, including verification status
  • In accordance with departmental objectives, use and share prior experiences in solving complex problems in creative and effective ways.
  • Plan, design, develop, implement, validate, and maintain software for the monitoring, reporting, and analysis of clinical trial data in accordance with department SOPs.
  • Collaborate with statistician and assist in the development of the statistical analysis plan (SAP).
  • Help develop and review case report forms and assist in the review of the clinical trial database system, structure, and validation.
  • Develop project specific and departmental standardized programming tools and routines for analysis.
  • Facilitate communication with and provide guidance to CROs/external vendors (data management CROs) to achieve defined objectives.

EXPERIENCE AND QUALIFICATIONS:

  • Strong communication skills
  • Ability to articulately communicate complex information to others and to comprehend complex analysis issues. Being visible and approachable.
  • Ability to communicate verbally and in writing in a clear and timely manner; ability to listen to and understand the clinical study team and statistical programming department are required.
  • Ability to effectively express concepts and points of view in individual and informal group situations.
  • Ability to present ideas in an organized and concise manner.
  • Strong problem-solving skill including debugging code, looking up reference materials and documentation, and contacting appropriate support.  Must be able to exercise sound judgment within departmental practices in selecting methods and techniques to solve problems.
  • At least 7 years of experience in clinical application development (using SAS) in the pharmaceutical/biotech industry.
  • Experience in the preparation and/or defense of regulatory submissions is required.
  • Proficiency with SAS/BASE, SAS/STAT, SAS macros, SAS/GRAPH, PROC SQL, and PROC REPORT.
  • Must be familiar with basic statistical concepts, such as: linear regression analysis, analysis of variance, hypothesis testing, non-parametric analysis, categorical data analysis, confidence intervals, p-values and capable of implementing these ideas in clear, concise SAS code for the purposes of data analysis and reporting.
  • An understanding of clinical trial principles and regulatory requirements, including a basic knowledge of FDA/ICH guidelines and the software development life cycle; experience dealing with FDA/regulatory requests.
  • Strong familiarity with CDISC data structure including SDTM and ADaM.
  • Must be flexible and able to work both independently and as part of a team within a dynamic, interdisciplinary.
  • Ability to prioritize and handle multiple tasks simultaneously is a must.
  • Strong documentation skills. 
  • Bachelor’s degree, preferably in statistics, math, computer science, or similar discipline is required. A Masters degree in statistics is strongly recommended.       

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

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95) Senior HFM Analyst – Contract (Southern California)

DESCRIPTION:

  • Perform HFM (Hyperion Financial Management )/FDM technical development and QA functions.
  • Using Financial Data Quality Manager (FDQM) and HFM consolidation, validation and execution.
  • Ensures that plans for system technologies integrate effectively with multiple application and enterprise layers of hardware and software.
  • Experience with Hyperion (9.x and higher 11.1.1.X) in the areas of design, development, deployment, and database administration.
  • Centrally managed and collaborated financial information and processes with HFM.        
  • Translate high-level business requirements into detailed functional specifications
  • Lead all testing activities and resources prior to UAT ensuring quality and requirements are met ensure compliance to system architecture, methods, standards, practices and participate in their creation.
  • Updating HFM dimensions and metadata 

EXPERIENCE AND QUALIFICATIONS:

  • Ideally a background in finance or accounting or supporting accounting consolidations
  • Project management experience
  • Oracle-Hyperion EPM 11 Suites including (Hyperion Workspace, Shared Services, Hyperion Financial management, Interactive Reports, Web Analysis, etc), Hyperion Essbase OLAP Server, Analyzer, Pivot Table, Hyperion Performance Suite , Hyperion Financial Management, and Oracle SOA          
  • Bachelor's Degree in finance, accounting or information systems.

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

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96) R&D Scientist (Senior Scientist) – Full Time (San Francisco or Greater Bay Area) W146KQ

DESCRIPTION:

  • The successful candidate will be a self-starter, enjoy working in a fast-paced multidisciplinary team environment, and be motivated to develop technologies with a significant clinical impact.
  • Leading in-lab efforts to develop novel nucleic acid based tests, including planning, feasibility testing, protocol development, optimization, verification and validation, and launch
  • Designing and coordinating the execution of effective experiments and analyzing data
  • Making experimental decisions to meet timelines
  • Documenting research progress under a quality management system
  • Communicating progress directly with colleagues and senior management

EXPERIENCE AND QUALIFICATIONS:

  • Track record of originating new methodologies and developing novel nucleic acid techniques.
  • Experience with nucleic acid technology relating to PCR, qPCR, multiplex PCR, and digital PCR.
  • Experience with next generation sequencing.
  • Demonstrated success in applying independent scientific judgment in experimental design and analysis.
  • Proven success in managing collaborative and individual projects, skills at writing clear SOPs and reports, and experience with Design Control a plus.
  • Strong analytical and problem solving skills.
  • Adept with Excel, basic statistical analysis.
  • Programming (e.g. PERL, python) and databases experience (SQL) a plus.
  • Strongly prefer Ph.D. in molecular biology or closely a related field and at least 4 years of industry experience.

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

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97) Senior Global Project Manager – Full Time (San Francisco or Greater Bay Area) B100FQ

DESCRIPTION:


As a key member on project teams the project manager is expected to be knowledgeable about the overall program in order to be strategic in planning, team management, and process management. This is achieved by delivering high quality project management support and other high value services to enable team and project success.

Responsibilities:
  • Applying project management expertise, methodologies, & department standards
  • Communicating effectively with team members, senior leaders, and the broader organization
  • Leveraging well developed interpersonal skills to build & maintain positive working relationships with customers and key stakeholders
  • Contributing to functional excellence and business improvement initiatives
  • Using project knowledge to be strategic in planning short-, mid-, long-term project  plans and  identifying interdependencies
  • Developing, maintaining, tracking, and managing a high-quality, integrated project plan to enable accurate reporting and decision making
  • Managing the critical path of the project and key project risks
  • Using strong project and organizational knowledge, leadership and active facilitation to enable effective team meetings and high performance teams
  • Managing team-level and corporate processes effectively, using strong project and process knowledge, to drive team deliverables

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated ability to think strategically when planning, managing teams, and managing processes
  • Strong project management to enable precise execution
  • Skillful use of interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance
  • Excellent communication and customer service skills, which enable successful collaboration with executive level stakeholders internally and externally
  • Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
  • Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems.
  • Proven leadership skills, executive presence, maturity, emotional intelligence
  • Ability to work effectively with cross-functional teams
  • Ability to work in a highly matrixed organization with non-co located teams
  • Ability to travel internationally
  • 10 years of pharmaceutical/biotech industry experience and a minimum of 3 years of Project Management experience supporting cross-functional drug development teams (clinical, clinical operations, regulatory, CMC, device, diagnostics, or Phase I-IV) is required. Pharma/biotech drug development experience is preferred.
  • Bachelor’s Degree required. Scientific degree preferred. 
  • Advanced degree (Science, MBA, PM) preferred.

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

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98) Biostatistics Sr Manager / Associate Director/ Director – Full Time (San Francisco or Greater Bay Area) J140FB

DESCRIPTION:

Description:

This position reports to the VP and has no direct reports. The preferred candidate will have experience in the pharmaceutical or biotechnology environment setting a high bar of excellence in the analysis and reporting of clinical study data to internal stakeholders as well as to external audiences (external experts, journals, regulators). Ideally, this experience would include exposure to the design, analysis and reporting of clinical studies in late stage clinical development.

  • Support the development of innovative and efficient plans for developing new medicines in a variety of therapeutic areas.
  • Works with Biometrics, Clinical Development and Operations, Regulatory Affairs, DMPK and Project Management to meet project deliverables in a timely and scientifically sound manner.
  • Provides technical statistical expertise, innovation and partnership on study design and endpoint selection, calculates sample sizes and prepares the statistical section of study protocols.
  • Independently develops and authors statistical analysis plans.
  • Collaborates in the review of protocols, case report forms, data specifications, CSRs and other study related documents
  • Performs quality control of analysis data and TFLs
  • Utilizes knowledge of guidance documents to provide statistical advice, and uses knowledge of literature to provide data analysis and presentation methods to support publications and presentations.
  • Ability to work on multiple clinical trials across multiple therapeutic areas.
  • Proactively solicits input from others to gain common understanding and agreement.
  • Plans and performs exploratory analyses of existing study data for publications, reimbursement negotiations, drug defense strategies and further development planning.
  • Provides Biostatistical input into strategic decision making
  • Represents the outputs of analyses with key audiences, including internal stakeholders, external experts, DSMBs, regulators and reimbursement committees
  • Plays an active role in shaping late stage development programs (Phase 2B, Phase 3A, Phase 3B)

EXPERIENCE AND QUALIFICATIONS:

  • PhD degree (required) in Biostatistics or equivalent.
  • 8+ years of experience in Clinical Development in a pharmaceutical or biotechnology setting in the statistical analysis of biomedical data.
  • Late-stage development experience in working in teams and in interacting with key internal and external stakeholder groups, including regulatory agencies
  • Working knowledge of the regulations and procedures relating to Biostatistical analysis and interpretation of late-phase development studies
  • Excellent English verbal and written communication skills.
  • Scientific programming capability with statistical software packages; SAS and/or R preferred
  • Detail oriented and well organized.
  • Ability to work on several projects simultaneously.

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

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99) (Senior) VP Medical Oncology – Full Time (South San Francisco) ZR121P

DESCRIPTION:

  • Lead medical and clinical direction for the oncology clinical programs
  • Be the oncologist medical representative of the company to potential investors and partners
  • Lead and develop all protocols for the oncology programs and work closely with the clinical investigators and the project teams
  • Provide medical monitoring for sponsored oncology trials
  • Establish and lead efforts for publication planning and investigator sponsored trial program
  • Lead advisory boards and investigator meetings
  • Lead clinical research teams and manage the clinical operations department
  • Prepare and deliver proposals, plans and updates to the governance committees at regular intervals and when requested
  • Develop processes and standards that are in accordance with GCP and ICH guidelines to enable efficient and consistent clinical activities
  • Work effectively with internal stakeholders (e.g. Biometrics, Research, Regulatory Affairs, CMC) and external stakeholders (e.g. investigators, FDA, NCI) to ensure efficient execution of the clinical programs

EXPERIENCE AND QUALIFICATIONS:

  • Thorough understanding of clinical hematology/oncology and the drug development process from phase I-III. 
  • Significant experience with later stage clinical trials, successful track record of NDA/BLA submissions, and experiences with FDA and ex-US regulatory authorities are highly desired
  • Deep understanding of cancer cell biology and its application to clinical experimentation
  • Thorough understanding of relevant nonclinical development in hematology/oncology areas
  • Strong implementation skills
  • Substantial experience with developing clinical protocols and medical monitoring
  • Must have good rapport with investigators and viewed as a peer to investigators; pre-existing relationships with global KOLs a plus
  • Familiarity with ICH and other regulatory requirements related to clinical activities
  • Strong and demonstrated effective leadership of multi-disciplinary teams including an ability to appropriately prioritize and resource to drive for results, use sound judgment in complex situations, to effectively influence and work with others at multiple levels within and outside the organization is required;
  • Ability to work independently within a defined strategic context, contribute to strategy and take initiatives and assess risks
  • Excellent organizational, communication, and presentation skills
  • Must be able to present well to regulators, investors, and partners
  • Willingness to travel as needed
  • MD with recent experience (last 3 years) and in hematology/oncology clinical development trials in the pharmaceutical industry; Minimum of 6 years experience working in clinical oncology drug trials.
  • A minimum of 10+ years of experience in drug development phase I-III in the pharmaceutical or biotech industry

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

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100) (Senior) Bioinformatics Scientist – Full Time (New York) GP143V

DESCRIPTION:

  • Working with standard bioinformatics tools and visualization packages
  • Automating and refining the processing and analysis of large data sets
  • Developing and using bioinformatics pipelines to prepare and analyze data
  • Designing, developing, and maintaining databases for scientific and commercial applications
  • Analyzing and working with NGS data, ideally whole genome sequence data


EXPERIENCE AND QUALIFICATIONS:

  • PhD in Bioinformatics, Computational Biology, Computer Science, Mathematics, Statistics, Genetics, Biology or related Genetics field with additional postdoctoral or industry experience (for Senior role)    
  • Proficiency in Python, Perl, Java, C/C++, and R programming
  • Good working knowledge of current best practices in genetic variant discovery, variant analysis, and validation methods
  • Experience with Whole Genome sequence data required (e.g. not microbes, plants etc.)
  • Strong organizational, written, and communication skills
  • Good analytical and problem solving abilities
  • A proven publication record
  • Experience in human genetics is highly preferred
  • Enjoys working in highly collaborative environment with diverse team to tackle complex problems
  • Is disciplined and driven to deliver ongoing research results
  • Has a positive attitude with willingness to be hands on when needed
  • Highly organized
  • strong written and verbal communicator
  • Has hard work ethic with emphasis on execution

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

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101) 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

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102) CTM / Associate Director Clinical Operations – Full Time (San Francisco or Greater Bay Area) 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

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103) 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

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104) 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

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105) 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

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106) 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

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107) 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

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108) Biotech Recruiter / Sourcing Specialist – Full Time or Part Time (San Francisco Bay Area)

DESCRIPTION:

  • We have openings for several recruiters and are therefore flexible in terms of the work arrangement. These positions are remote (work from home office). We are open to anywhere in the USA but prefer candidates in the San Francisco Bay area.
  • Primary responsibilities are to source open positions with qualified candidates
  • Document/track recruiting activities in candidate tracking system.
  • Source, screen and interview candidates to determine fit for open positions
  • May handle specific client accounts and interact with clients if experience warrants this

EXPERIENCE AND QUALIFICATIONS:

  • MUST have minimum of 2 years of solid recruiting experience
  • Experience with Pharma, Biotech, Diagnostics or Medical Device companies is REQUIRED
  • Prior experience and absolute comfort with making cold calls
  • Must be self-motivated, present well and be able to develop relationships with candidates
  • 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
  • Must have established home office situation; Prefer those who have previously worked remotely
  • Bachelor degree is REQUIRED
  • Must live in the United States and have U.S. work status

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

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109) CRA – Full Time (San Francisco or Greater Bay Area) XB128G

DESCRIPTION:


  • 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. 
  • Reports to Associate Director, Clinical Operations.
  • 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

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110) Recruiting Assistant – Part Time Position (San Francisco Bay Area Preferred)

DESCRIPTION:

This is an entry level work from home position with flexible hours that may range from 15 to 30+ hours per week, depending on workload.   This work can be completed during any shift (day, evening, night), but occasionally specific hours may be required.   In this role you will be responsible for searching information from job databases such as LinkedIn and then entering that information along with the LinkedIn PDF or attached resume into an Applicant Tracking System.  This position helps the technical recruiting process and you will work with multiple recruiters who are searching for particular skills for open positions.  You will use a search criteria provided by each recruiter for a particular job.  You will search for candidates who match the criteria for the job specifications. 

Essential Job Functions:
  • Receive search instructions from various recruiters
  • Perform timely and accurate searches in LinkedIn or other databases according to instructions provided
  • Deciding on profile ‘fit’ according to criteria provided
  • Entering those profiles who fit the criteria into a database, completing various fields within the database according to procedure
  • Attach the LinkedIn PDF or resume into the database
  • Emailing list of profiles entered to the recruiter(s)

EXPERIENCE AND QUALIFICATIONS:

  • Excellent knowledge of internet and LinkedIn Professional Networking database
  • Must be able to understand the various search fields on LinkedIn (by skill, company, location, connection, etc.)
  • Fast and accurate typing/data entry skills
  • Attention to detail, including accurate spelling
  • Thoroughness, decision making, independence, and analyzing information
  • Positive attitude and eagerness, and adaptability
  • Proficiency with MS Office products, email and general computer skills. 
  • MS Excel proficiency a plus
  • Must have your own home computer with high speed internet service
  • Excellent written and verbal communication skills, including a high command of the English language
  • Bachelor’s degree preferred

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

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111) Sr Human Resources Coordinator/ Associate / Manager – Full Time (San Francisco Bay area)

DESCRIPTION:

  • Onboarding/ Outboarding staff and maintenance of employee records
  • May run payroll using the vendor payroll system
  • Responsible for worker's compensation audits and responses / maintenance of files to State Employment development offices
  • Registration and maintenance or business in states outside of California
  • May set up and confirm candidate interviews with clients
  • May post job advertisements
  • Stay in contact and maintain relationships with contract workers at clients
  • Identify and screen qualified candidates for open positions in the client facilities (~40% of the time is spent on recruiting)
  • Other tasks as needed

EXPERIENCE AND QUALIFICATIONS:

  • Excellent computer skills: Applicant tracking systems; database experience, Microsoft Word, Excel, Outlook
  • Ability to maintain a high level of confidentiality
  • Bachelor’s degree required -- BS/BA in Biology or Life Science preferred.
  • 2 to 5 years in  a Human Resources function; Preferably in the pharmaceutical, biotech, or medical device industry
  • Experience in a fast paced start-up environment
  • 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.
  • Must have exceptional interpersonal skills 
  • Excellent organizational skills and the ability to work independently are extremely important.
  • Must live in California

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

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112) Recruiting Coordinator – Full Time (San Francisco Bay Area)

DESCRIPTION:

  • Drive, coordinate, and facilitate overall Talent Acquisition processes.
  • Manage special projects as necessary to ensure consistency for business practices
  • Schedule interviews (in person, phone, videoconference) and may gather feedback from candidate
  • Help with recruiting and sourcing efforts for specific jobs
  • May perform other related duties as required and/or assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Interacts with all levels of personnel in and outside of the company.
  • Excellent written and oral communication skills.
  • Ability to interface with varying personal styles in an effective way.
  • Good judgment, tact and diplomacy with internal and external customers.
  • Ability to handle confidential and proprietary information.
  • Must possess self-motivation, enthusiasm, and a positive demeanor toward the job, the company and their work team.
  • Effectiveness in this role requires a functional knowledge of corporate operations
  • The job encounters recurring work situations with occasional variations from the norm, involving a moderate degree of complexity.
  • Accuracy is required in performing all functions of this position. 
  • Initiative and organization skills are extremely valuable to ensure a smooth office operation. 
  • The incumbent normally receives no instruction on routine work, general instruction on new assignments.
  • Excellent computer skills
  • Recent graduate with a bachelor's degree in Science or Human Resources; or experienced Coordinator / Administrative Assistant
  • This position offers career growth in the area of Recruiting

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

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