Clinical and Clinically Related Jobs

The Inspection Specialist supports our Company’s organizations by coordinating, managing, and preparing for Good Clinical Practice (GCP), Pharmacovigilance (PV), and Investigator Site inspections conducted by global health authorities. This position is in the Quality department.

Major Responsibilities and Accountabilities

Coordinates scheduling and logistics for inspection related activities.
Collaborates with other Pharma functional areas for activities related to inspection preparation. Activities include, but are not limited to, preparation of relevant materials and conducting inspection related training.
Participates in pre-inspection visits of investigator sites.
Participates in health authority inspections and helps ensure that roles and responsibilities have been defined and assigned for each inspection. Assumes a role as required by the scope and nature of the inspection.
Provides guidance to inspected parties regarding the completion of inspection corrective and preventative action plans (CAPAs).
Assists in the preparation, conduct and management of mock inspections conducted of our Company’s functional areas.
Assists in developing and maintaining policies, standard operating procedures (SOPs), and guidelines for preparation and conduct of inspections within our Company’s Pharma.
Assists in preparing periodic summary reports and trend reports related to company inspections.
Develops and maintains expertise in international GCP regulatory requirements, international PV regulatory requirements, and policies, SOPs and project-specific procedures within Pharma applicable to the clinical trial methodology and Pharmacovigilance processes.
Monitors trends in health authority inspection activities to proactively identify potential areas of risk for the company.
Responsible for the coordination of Inspection Readiness (IR) modules and if required provides a country-specific /function-specific summary report.
Provides support to the IR Program Manager.
Provides support to and communicates with Inspection Readiness Key Contact (IRKC) personnel globally.
Assists in identifying needs for updates to training materials, IR modules and all documents required for the IR program.

EXPERIENCE AND QUALIFICATIONS:

Minimum of a Bachelors degree in a scientific or health-related field with at least 5 years of relevant industry experience
Minimum of 2 years in quality assurance/compliance required with a working knowledge of GCP and PV regulations.
Prior auditing and/or or health authority inspection experience highly desired.
General computer proficiency (e.g., Microsoft Office Suite applications).
Proven project management skills
Ability to work both independently and in a team environment
Strong communication skills; verbal and written
Critical thinking and decision-making skills
Detail-oriented with the ability to prioritize, organize, plan and manage multiple tasks efficiently
Prior participation in GCP and/or PV inspections is desirable
GCP experience required for consideration.

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

2) Senior Clinical Research Associate – Full Time Position (San Francisco Bay Area) T16GL

DESCRIPTION:

Study conduct of ongoing Phase 1 trial in 10 US centers, and study start up for Phase 2 trial in 10 centers. Design, plan and implement the overall direction of clinical research projects. Draft and participate in the development of relevant documents for Phase 1 through 3 studies including protocols, informed consent forms, CRFs, study manuals, monitoring plans, data management plans, abstracts, presentations, and manuscripts. Assist in compilation of investigator brochures, under close supervision.

Assist in the preparation of safety, interim and final study reports.
Monitor (perform site visits for data collection and resolution of data discrepancies, source data verification, and review of regulatory documents/files, if applicable) or co-monitor with CRO/regional CRAs as required.
Assist in site selection, study implementation and ongoing management of study sites either directly or via service providers.
Participate in forecasting study drug supply requirements and managing logistics.
Build and maintain CRO/service provider relationships.
Coordinate and/or participate in Investigator meetings.
Interact with investigators for protocol development, presentations and publications.
Train study coordinators and investigators on Good Clinical Practice/ICH
Participate in the development of best practices for Phase 1 through 3 study management.
Requires minimal direction to determine methods and procedures on new assignments.
Domestic Travel up to 25%.

EXPERIENCE AND QUALIFICATIONS:

A BS or BA in a relevant scientific discipline and minimum 4 years related experience in the pharmaceutical industry or equivalent.
Must have experience managing service providers, including Contract Research Organizations (CROs), and coordinating the work of regional CRAs
Oncology experience is required
Ability to travel up to 25% in the US
Working knowledge and experience with Outlook, Word, PowerPoint and Excel.
Working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
Must demonstrate strong attention to detail, meticulous follow-through, and the desire to thrive in a fast paced environment.

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

3) International Auditor – Pharmacovigilance – Full Time Position (San Francisco Bay Area) MR62G

DESCRIPTION:

The International PV Auditor supports by applying solid knowledge of Pharmacovigilance (PV), Good Clinical Practice (GCP) and international regulations to the auditing process to independently address a variety of compliance issues associated with drug development and post-authorization.

Major Responsibilities and Accountabilities

Perform and/or lead primarily PV audits of internal systems and external service providers/business partners.
Perform all activities including audit preparation, conduct, presentation and timely reporting of audit findings, prepare a written audit report, and evaluation of corrective/preventative actions (CAPAs).
Participate in and/or provide leadership to small audit team for PV/GCP systems audits.
Participate in solving ‘for cause’ situations or complex quality issues.
Assist Inspection Management Team in preparation for and during regulatory authority inspection which involve PV activities and perform mock inspections.
Partner with other Pharma personnel including Drug Safety, Clinical Operations, Legal, Regulatory Affairs etc) regarding PV compliance issue.
Provide training and/or education to PV functional areas and groups.
Contribute to the development and revision of procedures related to PV and GCP auditing.
Participate in Quality Risk Management Quality Area Teams (QATs) and advice QATs in areas of expertise.

EXPERIENCE AND QUALIFICATIONS:

Bachelors or higher education in a biomedical / scientific discipline with significant pharmaceutical/biotech industry experience.
5 or more years Experience in Quality Assurance / Compliance role in an international environment and/or in Drug Safety.
Auditing experience in PV preferred.
Knowledge of pharmaceutical research and development, GCP, and pharmaceutical industry auditing/compliance activities required.
Proven record of working with cross-functional teams with an international orientation.
Working knowledge of international safety reporting activities/regulations.
Analytical, problem solving and decision making skills in a complex, fast-paced, and changing environment.
Strong communication skills; verbal, written and presentation.
Ability to influence and negotiate effective solutions, solid social and interpersonal skills
Excellent organization skills with an ability to effectively prioritize tasks.
Computer proficiency
In addition to English fluency, knowledge of another European and/or Asian language is desirable.
Willingness to Travel <40% International and Domestic

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

4) Clinical Laboratory Director – Full Time Position (San Francisco Bay Area) G64HY

DESCRIPTION:

Provide oversight of the clinical laboratory, including ensuring competency of personnel performing test procedures; recording and reporting test results promptly, accurately and proficiently; and assuring compliance with all applicable regulations.

Responsibilities:

Working with other members of senior management to implement and scale the Company’s clinical laboratory operations
Ensuring that the clinical laboratory develops and uses a quality system approach to testing that provides accurate and reliable patient test results
Ensuring compliance of pre-analytical, analytical, and post-analytical processes with applicable regulations
Leading efforts to achieve and maintain appropriate accreditation (e.g., CAP) and licensure (e.g., NYS) for the clinical laboratory
Recruiting and retaining talented and qualified clinical laboratory personnel
Providing written duties and documenting the delegated responsibilities for all laboratory staff
Ensuring proper training and competency of all clinical laboratory personnel
Reviewing and releasing clinical test results
Leading communication with clients as it relates to laboratory testing and reporting
Developing clinical laboratory budget, ensuring laboratory operates within budget
Informing senior management of progress, problems and opportunities

EXPERIENCE AND QUALIFICATIONS:

Must meet the qualifications specified in the CLIA regulations (§493. 1443) and California Business and Professions Code (BPC 1209 (a)) to direct a clinical laboratory offering high complexity genetic molecular biology tests, including:
Qualified as a laboratory director in CA:
MD licensed to practice in CA, board certified (or eligible) in anatomic or clinical pathology by the American Board of Pathology or
MD licensed to practice in CA, with at least one year of laboratory training during residency, or at least two years of experience supervising high complexity testing or
PhD in a chemical, physical, biological, or clinical laboratory science, and certified by an HHS-approved board
A NY Certificate of Qualification as a Laboratory Director in Genetics
At least 5 years’ experience with advanced genomics technologies, preferably including next generation sequencing
At least 5 years’ experience as director of a clinical laboratory performing high-complexity genetic testing
Proven record of success administering clinical laboratory operations in a rapid growth environment

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

5) Clinical Contracts Administrator/(Sr) Manager level – Full Time Position (San Francisco Bay Area) RS55B

DESCRIPTION:

This position can be at the Administrator to Sr Manager level depending on experience. The contracts administrator/paralegal will be a member of the Legal Team, a tight-knit group of highly-motivated individuals in a positive, professional working environment. This person will assist attorneys and team members in the intake, drafting, negotiation and post-execution administration of non-disclosure, material transfer, clinical trial, vendor services, and other agreements. This individual must be a self-starter and comfortable working in a fast-paced environment with high volume production requirements, and meeting frequent tight deadlines under minimal supervision. This position will manage the process and workflow of contracts, assure compliance with existing agreements, and ensure the proper routing of documents for execution by corporate officers and perform other duties as assigned by attorneys and other team members. A clinical focus is strongly preferred although there will be overflow work in other business areas.

Duties:

Prepare drafts of agreements and negotiations with outside parties
Gather and confirm facts necessary to initiate contract formation with the Legal team and internal stakeholders
Generate initial contract drafts and prepare successive redlines
Perform initial review of contracts and comments from outside parties
Negotiation with outside parties
Prepare/format and finalize contracts for execution
Work with Legal team to administer a document-tracking database, including data entry and the generation of summary reports on agreement status
Monitor contracts for compliance with company and department policies
Perform other tasks as assigned by Legal team members

EXPERIENCE AND QUALIFICATIONS:

BA/BS and/or ABA-approved paralegal certificate, or other comparable legal experience
Minimum of 3 years experience in the review, negotiation and administration of clinical contracts (biotech preferred)
Intellectual property law background preferred
Excellent communication skills, both written and verbal
Excellent organizational and analytical skills
Demonstrated proficiency with Microsoft Office applications (Word, Outlook, Excel, Access) and experience with contract management and database applications
Flexible team-player with ability to balance multiple projects and instructions often with competing deadlines
Creative, self-motivated, self-starter with strong organizational, prioritization and interpersonal skills

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

6) Director, Clinical Operations – Contract or Contract to FTE (San Francisco Bay Area) Z29PS

DESCRIPTION:

Providing oversight for the Clinical Operations for a start-up company. Start-up of large Phase 2 trial in the US which will involve some domestic travel. In addition, contractor will be responsible for a small study in the UK (no or little travel).
Participate in strategic planning activities and translate strategic decisions into operational plans
Direct project needs with Outsourcing and planning/support functions such as Regulatory, Quality, etc.
Management of Clinical Operations staff
Direct creation and implementation of clinical infrastructure including SOPs, Training Guidance (aka guidelines) and cross-functional communication and interaction plan.
Participate and support, as needed: clinical study report writing, protocol preparation, and regulatory submissions
Identify resource needs for implementation of operational plans and develop a resource-tracking process
Develop and manage the functional area budgets; provide senior management with necessary updates on progress and changes in scope, schedule, and resources in a timely manner
Direct clinical program implementation to meet program timelines
Participate in oversight meetings and assist in the outsourcing review process; oversee the operational selection of various vendors as well as the review of proposal requests

EXPERIENCE AND QUALIFICATIONS:

Bachelor’s degree or equivalent in a scientific discipline
Advanced degree in the discipline of healthcare, life sciences , or business is a plus
10 or more years of clinical research experience with 5 or more years of experience in the development & management of clinical operations function and staff in a pharmaceutical and/or biotechnology start-up environment
Experience with international trials desirable
Experience with partnering and managing CRO relationships
Proven excellence in operational strategy
Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines essential
Participation in multiple late stage clinical trial programs; Phase 2 and or 3 experience required.
Demonstrated proficiency in the implementation, monitoring and management of clinical trials including clinical supply and document control functions, timelines and budgets with all phases of development (including regulatory processes and contract hurdles)

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

7) Clinical Trial Assistant – Full Time Position (San Francisco Bay Area) SG55B

DESCRIPTION:

Operational support for the day-to-day execution of clinical trials
Works according to ICH-GCP, regulations and Standard Operating Procedures
Identification and referral/resolution of clinical trial issues
Timely and accurate study-related communication to clinical personnel (internal and external including consultants and site personnel)
Prepares and disseminates clinical trial correspondence and assists with the development of trial manuals, tools and templates
Coordinates clinical trial meetings (e.g. investigator meetings, Study Management Team (SMT) meetings, CRA and CRO meetings), by arranging all logistics, necessary materials and recording/distributing minutes as required
Sets-up and maintains the Clinical Study File (CSF) in an audit-ready state
Manages the study status in the clinical trial management system
Ensures that necessary study supplies are available as per study timelines by liaising with the CRO
Provides input into trial documents such as the protocol, ICF, CRF, monitoring guidelines etc
May conduct co-monitoring visits with the CRO site monitor
Works with the Clinical Trial Manager on other aspects of the trial management as required
Helps with the collation and preparation of clinical portions of regulatory filings

EXPERIENCE AND QUALIFICATIONS:

Minimum of a Bachelor’s degree ; Life Sciences preferred
Minimum previous title of Clinical Trial Assistant or equivalent and minimum of 2 years clinical operations experience in a pharmaceutical or biotechnology company.
Local to the San Francisco Bay area; No relocation provided; Must have US Work Status

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

8) Clinical Research Associate/Senior Clinical Research Associate – Full Time Position (San Francisco Bay Area) R40DG

DESCRIPTION:

Oversees the conduct of assigned clinical studies including acting as liaison to clinical investigators & ensuring the quality and integrity of data. This position will independently perform clinical monitoring activities to ensure site compliance and adherence with study protocols, project plans, company SOPs, and FDA/ICH GCP regulations.

Responsibilities include but are not limited to:

Conduct Site Qualification, Site Initiation, Interim Monitoring, Site Close-out, and other study-specific visits including the completion of trip reports and follow-up letters after each visit
Verify that the investigator has adequate qualifications and resources including facilities, laboratories, equipment, and staff to safely and properly conduct the trial. Confirms that qualifications and resources remain adequate throughout the trial period
Ensure the collection and maintenance of required essential documents and ensure these documents are delivered to the Trial Master File
Ensuring the sites are adequately prepared and trained to participate in the clinical trial
Ensure that the investigator receives the current Investigators Brochure, all documents, and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirement(s)
Verify investigational product is handled according to the regulations
Report site status and develop a patient recruitment plan in conjunction with the site.
Verify that the investigator provides all the required reports, notifications, applications, and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial
Determine whether all adverse events (AEs) are appropriately reported within the time periods required by Good Clinical Practices (GCP), the protocol, the Ethic Committees (IRB/IEC), the sponsor, and the applicable regulatory requirement(s)
Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations
Maintain current, accurate and complete tracking tools and provide status updates including essential documents, monitoring visits, CRF collection, data entry, query status, SAE reporting, subject screening and recruitment, supplies inventory, and overall project timelines and budgets.
Prepare essential document packages for sites and review the completed site essential document packages for accuracy, completeness, and compliance with GCP. Ensure site essential documents are up to date, working with the CRA to collect documents from sites.
Maintain and ensure quality of the Trial Master File including tracking, review of documents and filing.
As needed, assist the Project Managers in the implementation of clinical projects by gathering information concerning therapeutic areas; reviewing protocol synopses and protocols; assisting in the generation of study specific case report forms, source documents and other study tools; identifying investigators and assessing their suitability; assisting in the management of clinical trial medications and supplies; interacting with service providers; scheduling and documenting team meetings, and assisting investigative sites with regulatory documentation.

EXPERIENCE AND QUALIFICATIONS:

BS in scientific discipline or pharmacy, RN, or BSN degree or equivalent experience
Minimum of 5 years on-site monitoring experience
Oncology background or experience is preferred
Ability to travel approximately 25% travel based on study demands
Good working knowledge of GCP/ICH Guidelines and all monitoring responsibilities
Formal certification as a Certified Clinical Research Associate (CCRA) is highly desirable
Effective written communication skills and computer skills are required

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

9) Clinical Research Associate/Senior Clinical Research Associate – Full Time Position (San Francisco Bay Area) R54OH

DESCRIPTION:

Responsibilities include but are not limited to:

Conduct Site Qualification, Site Initiation, Interim Monitoring, Site Close-out, and other study-specific visits including the completion of trip reports and follow-up letters after each visit
Verify that the investigator has adequate qualifications and resources including facilities, laboratories, equipment, and staff to safely and properly conduct the trial. Confirms that qualifications and resources remain adequate throughout the trial period
Ensure the collection and maintenance of required essential documents and ensure these documents are delivered to the Trial Master File
Ensuring the sites are adequately prepared and trained to participate in the clinical trial
Ensure that the investigator receives the current Investigators Brochure, all documents, and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirement(s)
Verify investigational product is handled according to the regulations
Report site status and develop a patient recruitment plan in conjunction with the site.
Verify that the investigator provides all the required reports, notifications, applications, and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial
Determine whether all adverse events (AEs) are appropriately reported within the time periods required by Good Clinical Practices (GCP), the protocol, the Ethic Committees (IRB/IEC), the sponsor, and the applicable regulatory requirement(s)
Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations
Maintain current, accurate and complete tracking tools and provide status updates including essential documents, monitoring visits, CRF collection, data entry, query status, SAE reporting, subject screening and recruitment, supplies inventory, and overall project timelines and budgets.
Prepare essential document packages for sites and review the completed site essential document packages for accuracy, completeness, and compliance with GCP. Ensure site essential documents are up to date, working with the CRA to collect documents from sites.
Maintain and ensure quality of the Trial Master File including tracking, review of documents and filing.
As needed, assist the Project Managers in the implementation of clinical projects by gathering information concerning therapeutic areas; reviewing protocol synopses and protocols; assisting in the generation of study specific case report forms, source documents and other study tools; identifying investigators and assessing their suitability; assisting in the management of clinical trial medications and supplies; interacting with service providers; scheduling and documenting team meetings, and assisting investigative sites with regulatory documentation.

EXPERIENCE AND QUALIFICATIONS:

BS in scientific discipline or pharmacy, RN, or BSN degree or equivalent experience
Minimum of 5 years on-site monitoring experience
Oncology background or experience is preferred
Ability to travel approximately 25% travel based on study demands
Good working knowledge of GCP/ICH Guidelines and all monitoring responsibilities
Formal certification as a Certified Clinical Research Associate (CCRA) is highly desirable
Effective written communication skills and computer skills are required
The individual must possess the ability to work closely with all disciplines within a small company, displaying innovative thinking, a strong sense of responsibility and accountability, and integrity.

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

10) Associate Director, Clinical Operations – Full Time Position (San Francisco Bay Area) PR55S

DESCRIPTION:

Reports to the Director Clinical Operations.
Participate in strategic planning activities and translate strategic decisions into operational plans for late stage clinical trial.
Work with CPMs and senior management to develop and implement project hiring plans to ensure efficient and cost-effective trial management.
Direct all aspects of global and domestic clinical trials to ensure delivery of company goals on time, within budget, and in compliance with SOPs and FDA and ICH/GCP guidelines.
Management of Clinical Operations staff with direct reports including both internal and external staff.
Responsible for hiring, retention, coaching, and performance appraisals of the staff.
Identify training needs and develop training plans for direct reports, including on-going training for current employees and training for new employees/consultants as appropriate.
Assist senior management in the development of resource projections for projects.
Contribute to building the clinical infrastructure including policies, procedures, guidelines, cross-functional communication, and interaction plans.
Work closely with Regulatory Affairs in the preparation and support of regulatory filings.
Participate and support as needed clinical study report writing and protocol preparation.
Contribute to the development and management of the clinical operations budget and relevant components of the department budget.
Provide senior management with necessary updates on progress and changes in scope, schedule, and resources in a timely manner.
Review and approve clinical contracts.
Direct clinical program timelines.
Provide oversight and assist in the formulation of the outsourcing review process; oversee the qualification and selection of various vendors as well as the preparation of proposal requests.
Identify and implement methods for improving communications/sharing ideas across departments and project team. Assist with resolution of cross-departmental issues.

EXPERIENCE AND QUALIFICATIONS:

Bachelor’s degree; advanced degree in the discipline of life sciences (MS/PhD/RN/BSN) a plus.
8 or more years of experience in the management of clinical operations function and staff in a pharmaceutical and/or biotechnology environment;
Demonstrated proficiency in the implementation, monitoring, and management of global and domestic clinical trials, CROs, timelines, and budgets; experience in Phase 3 (including regulatory processes and contract hurdles).
Management of the life cycle of multiple clinical studies highly desired.
Participation in a clinical trial program through NDA a plus.
Experience working for sponsors and managing CRO relationships required; additional experience working for a CRO a plus.
Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines essential.
Demonstrated ability to build networks and inspire, coach, and manage a high performing team that embraces change and innovation.
Effective at time/project management: organized, develops realistic project plans, modifies plans in response to obstacles, meets or exceeds deadlines/goals.
Proven ability to communicate with clear, compelling verbal and written messages and presentations.
Understands and effectively responds to multi-cultural communication styles and business practices
Ability to travel occasionally for work (this position is mostly in-house and has very little travel)
Basic relocation provided

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

11) Senior Clinical Research Associate II (SCRA) – Full Time Position (San Francisco Bay Area) Z55BZ

DESCRIPTION:

Reports to Clinical Program Manager (CPM).
May review and edit documents including protocols, informed consents, case report forms, monitoring plans, edit specifications, abstracts, presentations, manuscripts and clinical study reports
May write protocols and protocol amendments, with supervision
Will present at investigator meetings
May manage CROs and/or contract CRAs with guidance from CPM
Chair or participate in meetings or conference calls with CROs and multi-disciplinary study team
Assist in review of data and preparation of safety, interim and final study reports, and resolution of data discrepancies
Assist in setting and updating study timelines
Participate in abstract preparation, presentation preparation and manuscript development
Train clinical site staff to ensure protocol and regulatory compliance. May assist in training CRA I and CRA Assistant

EXPERIENCE AND QUALIFICATIONS:

Bachelor’s degree in a relevant scientific discipline or equivalent
At least 5.5 year of relevant experience as a CRA in the biotech / pharmaceutical (not diagnostics / device) industry in an in-house (not Regional monitor, CRO or Hospital / Site based position).
Phase 3 experience, Study start-up experience, and Global trial experience are desirable
Must have some experience with direct monitoring of sites (in order to manage the CRO; direct monitoring is not part of this job)
Experience in a start-up environment preferred
Knowledge of GCP and ICH guidelines
Ability to work collegially within a team
Able to perform routine assignments with general instructions and new assignments with detailed instructions
Must be able to go on occasional travel (this is an in-house position so very little travel is expected)
Proficiency with MS Word, Excel, Outlook, and PowerPoint
Basic Relocation Provided

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

12) (Senior) Clinical Program Manager – Full Time Position (San Francisco Bay Area) R55BS

DESCRIPTION:

Clinical Program Manager to manage multiple clinical trials.

Reports to an (Associate) Director, Clinical Operations
Manage late stage global clinical study teams, CRO’s and Vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
Manage CRA to SCRA level clinical operations personnel

EXPERIENCE AND QUALIFICATIONS:

Bachelor’s degree in a relevant scientific discipline or equivalent
At least 7 years of relevant clinical experience in the pharmaceutical industry or equivalent with 3+ years as a CRA in biotech or Pharmaceutical clinical operations (not a device or diagnostics company) environment, and 1 year prior experience as a CPM preferred
1+ years managing staff/direct reports preferred
Must be hands on and used to a start-up environment
Knowledge of GCP and ICH guidelines required
Proficiency in the implementation, monitoring, and management of clinical trials
Able to work collegially within a team and carry out duties/responsibilities with general instructions
Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project
Must be willing to travel occasionally (this is an in-house position so very little travel is required)
Previous experience as a CPM managing more than one trial in Phase 3 or a large Phase 2B trial
Study start-up experience is highly desirable
Global (Asia, Europe, South America, Middle East, or Africa) trial experience is highly desirable
Demonstrated stellar track record in the oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities.
Basic relocation provided

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

13) Clinical Research Associate II (CRA II) – Full Time Position (San Francisco Bay Area) LS55B

DESCRIPTION:

Reports to Clinical Program Manager (CPM).
May review and edit documents including protocols, informed consents, case report forms, monitoring plans, edit specifications, abstracts, presentations, manuscripts and clinical study reports
May write protocols and protocol amendments, with supervision
Will present at investigator meetings
May manage CROs and/or contract CRAs with guidance from CPM
Chair or participate in meetings or conference calls with CROs and multi-disciplinary study team
Assist in review of data and preparation of safety, interim and final study reports, and resolution of data discrepancies
Assist in setting and updating study timelines
Participate in abstract preparation, presentation preparation and manuscript development
Train clinical site staff to ensure protocol and regulatory compliance. May assist in training CRA I and CRA Assistant

EXPERIENCE AND QUALIFICATIONS:

Bachelor’s degree in a relevant scientific discipline or equivalent
At least 1 year of relevant experience as a CRA in the biotech / pharmaceutical (not diagnostics / device) industry in an in-house (not Regional monitor, CRO or Hospital / Site based position). 3+ years CRA experience is preferred;
Must have some experience with direct monitoring of sites (in order to manage the CRO; direct monitoring is not part of this job)
Knowledge of GCP and ICH guidelines
Excellent communication and interpersonal skills
Ability to work collegially within a team
Able to perform routine assignments with general instructions and new assignments with detailed instructions
Must be able to go on occasional travel (this is an in-house position so very little travel is expected)
Proficiency with MS Word, Excel, Outlook, and PowerPoint
Relocation from within California provided but local candidates are preferred

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

14) Medical Director, Medical Affairs – Full Time Position (San Francisco Bay Area) B28BY

DESCRIPTION:

Collaborate with Clinical Development in the strategic planning, management, and execution of Phase IIIB and Phase IV trials to support the medical and scientific platform. Position reports to the Vice President, Medical Affairs.

Provide day-to-day clinical and medical guidance while working closely on joint projects with the medical affairs team and broader organization; projects include medical affairs studies, scientific congress/conference strategy and planning, advisory boards, medical education grant review, publications, field force training, medical information standard response letters, health economics and epidemiology analyses, and marketing/policy related projects.
Collaborate with the medical affairs team comprising Medical Communications, Publication Planning, Medical Information, HEOR/epidemiology, MSLs, and Clinical Nurse Educators in the preparation for the commercialization of products.
Identify, develop, and maintain relationships with thought leaders. Collaborate with thought leaders to develop clinical therapeutic concepts that warrant additional study, identify messages for scientific communications based on preclinical or clinical data, and gain feedback on strategies to support the scientific and medical affairs plans.
Collaborate with Clinical Development in the strategic planning, management, and execution of Phase IIIB and Phase IV trials. Manage the Investigator Initiated Sponsored Trials review and grant process.
Collaborate with and provide scientific and clinical support and training for internal departments, including Marketing, Sales, Medical Science Liaisons, Clinical Operations, Research, Corporate Development, Government Policy, and Investor Relations, and for external audiences, such as patient advocacy groups, physicians, other health care providers, formulary and clinical guidelines decision makers, and various organizations within Takeda.
Participate in appropriate cross-functional and cross-company Clinical and Commercial teams to inform brand strategies and tactics and represent Medical Affairs.

EXPERIENCE AND QUALIFICATIONS:

MD degree
Minimum of 4 years in biopharmaceutical medical affairs and/or clinical development role and/or medical directorship of an outpatient hemodialysis center.
Experience in nephrology therapeutic area required
Demonstrated acumen in presenting clinical and pre-clinical data to external audience and senior management required.
Experience with post marketing Phase IV and Investigator initiated studies.
Experience with product launch preferred.
Strong leadership, team building, negotiation and ability to execute.
Exceptional verbal and written communication skills

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

15) Medical Director to VP Clinical Research (Consultant to Full Time; 20 – 40 hr/wk for 6 months) (San Francisco Bay Area) S36GQ

DESCRIPTION:

This position reports to the CEO
Communicate with investigators on ongoing clinical trials
Support NDA submission
Represent the company to the FDA ODAC

EXPERIENCE AND QUALIFICATIONS:

MD required; hematologist or Oncologist preferred
Experience with Phase 2B/3 oncology clinical trials in the pharmaceutical industry
Minimum of 7 years pharma industry experience
Note: Contrary to the above, a practicing oncologist (MD) may be considered for this position even if they have no pharmaceutical training. Hematological oncology preferred.

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

16) Manager/Senior Manager – Quality GCP Compliance (San Francisco Bay Area) B30US

DESCRIPTION:

As a member of the Quality team, this position is the primary liaison between QA and Clinical providing GCP (Good Clinical Practice) oversight and QA support to the Clinical group.

Manage the GCP audit program by ensuring appropriate plan, schedule, conduct and report of audits, coordination of audit follow-up including CAPA and corrective action
May develop and implement GCP training.
Work with the QA team to develop and implement system for compilation of audit data, verification and retrieval for trending and reporting.
Contribute to the development of the company’s QA concepts and principles and to achieve objectives in creative and effective ways.
Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables.
Exercises independent judgment in developing methods, techniques, and evaluation criteria in obtaining results.
Reports to Senior Director, Global Quality Assurance

MAJOR DUTIES OF POSITION:

Partner with the Clinical Department to help assure that all clinical trials are assessed for compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
Manage schedules, site visits and audits of clinical research organizations (CROs) to assure compliance with all applicable regulations and standards.
Collaborate with Clinical stakeholders, including but not limited to, Medical Affairs personnel, study teams and investigative sites. Provide guidance and feedback on regulations and best practices.
Coordinate, develop, maintain, and/or deliver GCP training programs.
Stay abreast of current regulatory enforcement trends and regulatory changes. Update Standard Operating Procedures (SOPs) or provide feedback on appropriate policy changes to align corporate policies and practices with regulatory updates. Implement training on changes as needed.
Perform internal audits and report to management significant compliance risks in the GCP area including periodic metrics, analysis and interpretation of audit findings. Provide recommendation to mitigate risks as appropriate.
Assist in resolving compliance issues and assessing impact of any deficits.
Create, review, and follow internal SOPs, to comply with US, EU, and Canadian requirements.
Represent Quality Assurance at meetings, and communicates compliance strategy and risks.
Operate within the limits of approved quality agreements with CROs.
May travel to perform GCP audits or site visits.
Support the site during regulatory inspections and provides QA expertise and assistance to other departments as required.
Maintain a work environment that fosters respect, open communication, collaboration integration, and teamwork.

EXPERIENCE AND QUALIFICATIONS:

BS/BA degree in a scientific or health-rated field with 8 years of progressive experience in the Pharmaceutical and/or Biotechnology industry with at least 2 years’ GCP experience at the manager level.
Knowledge of applicable FDA, EU and ICH regulatory requirements for GCP.
Proven experience in clinical compliance or clinical quality assurance.
Experience in managing and conducting compliance audits including leading internal process audits is required.
Must be an effective communicator and proven abilities to communicate complex information and concepts with clarity, including flexibility in approach to problem-solving, negotiating, and trouble-shooting issues and problems.
Proven ability to establish collaborative working relationships with internal and external stakeholders; strong team-orientation and the ability to work independently.
Ability to effectively prioritize and manage multiple projects and tasks.
Highly ethical, flexible, action and goal- oriented; works well under pressure, and is effective in meeting tight deadlines.

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

17) Distribution Project Manager – 4 month contract (New Jersey) 820

DESCRIPTION:

This position manages the distribution logistics for assigned projects. Applies the distribution plan and schedule in the most efficient and competitive way within the agreed timelines and meeting the internal or external customer requirements. Coordinate efforts within the global distribution organization. This activity supports the efforts of the larger, global Clinical Supplies Scientific Core Platform and R&D. This role will lead or assist in the implementation of improvements in distribution strategy, quality, regulatory compliance, cost effectiveness and efficiency.

Duties:

Contribute to the development and apply the distribution strategy (for IVR and non-IVR studies) that ensures continuity of IP at depots and investigational sites.
Ensure adequate IP stock at depot and site levels.
As necessary, support relabeling activity or transfer of IP between various sites.
Ensure all critical parameters are considered for every distribution strategy; IVRS/IWRS specifications (e.g. initial or resupply quantities); any QP, project, study, expiry, customs, import/export, brokerage or country specific requirements.
Generate and/or review IP shipment requests for accuracy & completeness prior to issuance.
Ensure accuracy of IP receipt for all shipments and availability in IVR for applicable studies.
Serve as point of contact for all contracted distribution activities.
Provide adequate communication and documentation (including customs values) relevant to the distribution plan and the movement of all investigational products.
Contribute to the quotation for customers; distribution projects to include budgeting and forecasting.
Generate and maintain data for distribution metrics.
Offer creative solutions/proposals to optimize the distribution supply chain.

EXPERIENCE AND QUALIFICATIONS:

Excellent knowledge of business units, scientific core platforms and interfaces, clinical study protocols and IP related activities with particular emphasis on global distribution and strategy
Thorough understanding of GMP & GDP (IP production and distribution)
Thorough understanding of IVR/IWR systems
Good understanding of CMC and clinical study conduct activities
Excellent ability to interface with customers and distribution partners (couriers, brokers, vendors)
Excellent oral and written communication skills
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.
Experience with MS Office Suite (Excel, Word, PowerPoint), flow diagramming and project management software required.
Bachelor of Science degree (BS) in Health Science or related discipline and at least 3 to 5 years experience in pharmaceutical business experience required.
Must be well versed in all aspects of the clinical supply chain process, GMP, GDP and other regulatory requirements as they pertain to investigational products.

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

18) Clinical Trial Operations Manager – Oncology – 6 month contract (Massachusetts) 000

DESCRIPTION:

Responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, observational trials, compassionate use and registries) including data management activities in compliance with GCPs, SOPs and standards within established timelines and budgets.
Involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of homogeneous high quality data, in close collaboration with other CSO department representatives (e.g. Medical Operations).
Lead the clinical trial team (CTT) (including representatives from CSUs/affiliates/CROs, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics and other relevant departments) for the operational aspects of the study. Liaise with the feasibility manager to review and assess country feasibility.
Liaise with clinical purchasing to prepare the RFP (request for proposal), review vendors’ specifications and oversee vendor activities and deliverables (i.e. Central Lab, IVRS, data management, monitoring, Meeting Planner). Liaise with coding and TIM representatives when applicable.

EXPERIENCE AND QUALIFICATIONS:

Capable of interacting effectively with scientists and managers within and outside CSO SCP; serve as internal consultant on assigned area and liaise with external organizations on projects.
Strong interpersonal and communication skills (verbal and written), including good presentation skills
Ability to handle multiple routine tasks and to prioritize. Ability to manage complex or uncommon tasks with appropriate level of supervision/ training/coaching.
Good organizational and Project Management skills
Decision-making and problem-solving skills adequate to address routine operational challenges
Ability to work autonomously for routine responsibilities and to efficiently & effectively provide status reports
Ability to anticipate and timely escalate issues and to define and/or implement appropriate action plans
Cross-functional team leadership skills including the ability to foster team spirit and team motivation (team work)
Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems), processes and SOPs
Experience in managing and leading meetings (Clinical Trial Team, expert meeting, etc.); international meeting leadership experience preferred
Ability to work in an international environment with internal and/or external partners (CROs, etc.)
Strong English skills (verbal and written if English is the second language)
Ability to adapt and be flexible to change and managing internal and external impediments
Understanding of data base concepts
Knowledge or ability to rapidly gain knowledge of basic programming/query languages
Knowledge of industry data management standards and practices
At least 3-5 years of recent Oncology experience, 2+ years of clinical research field monitoring and/or data management experience is preferred.
Prior management and/or supervisory experience in coordinating international clinical trials is strongly advised along with CRO management.
Bachelor’s degree (advanced degree preferred) plus at least 7 years of experience in pharmaceutical industry or clinical-related discipline including at least 5 years clinical research experience.
Requires Data Management experience, one position will be more focused on Data Management than the other, and therefore will need true hands-on DM experience.

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