Clinical Trials Manager, Biomarker/Bioanalytical Operations
Gilead Sciences
June 26, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Clinical Trials Manager, Biomarker/Bioanalytical Operations
Key Responsibilities:
- Act as key biomarker/bioanalytical operational (BBOps) contact for internal/external stakeholders; implement biomarker and bioanalytical strategies.
- Participate in multiple Phase 1–4 clinical study teams.
- Plan and coordinate operational activities for collection, delivery, and analysis of biological specimens.
- Provide sample management expertise to Study Management Teams (SMTs), Biomarker SubTeams (BSTs), and Clinical Pharmacology Subteams (CPSTs).
- Ensure biological samples are of good analyzable quality; collected with high standards of ethics and informed consent.
- Manage laboratory vendors day-to-day to deliver within contracted scope; maintain operational interface between SMT and vendors.
- Critically evaluate proposals/protocols and assess feasibility/budget; identify operational challenges and provide resolution plans.
- Lead/organize biomarker and bioanalytical operational meetings; maintain internal databases/document repositories.
- Review study documents (protocols, informed consents, etc.); interpret and explain protocol requirements.
- Contribute to RFPs, CRO/vendor selection, tools/process development, and special projects.
- Support recruiting/hiring and professional development for CPA/CTMA/Sr. CTMA.
- Assist with inputs to protocols, case report forms, informed consents, study plans, presentations; help prepare interim/final study reports; resolve biomarker data discrepancies.
- Ensure work complies with established practices/policies and regulatory requirements; travel may be required.
Basic Qualifications:
- Bachelor’s degree + 5 years’ experience, or Master’s degree + 3 years’ experience.
People Leader Accountabilities:
- Create inclusion; develop talent; empower teams.
Compensation/Benefits (as stated):
- Salary range: $146,540.00–$189,640.00; may be eligible for discretionary bonus/long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions (current employees/contractors):
- Apply via the Internal Career Opportunities portal in Workday.
Key Responsibilities:
- Act as key biomarker/bioanalytical operational (BBOps) contact for internal/external stakeholders; implement biomarker and bioanalytical strategies.
- Participate in multiple Phase 1–4 clinical study teams.
- Plan and coordinate operational activities for collection, delivery, and analysis of biological specimens.
- Provide sample management expertise to Study Management Teams (SMTs), Biomarker SubTeams (BSTs), and Clinical Pharmacology Subteams (CPSTs).
- Ensure biological samples are of good analyzable quality; collected with high standards of ethics and informed consent.
- Manage laboratory vendors day-to-day to deliver within contracted scope; maintain operational interface between SMT and vendors.
- Critically evaluate proposals/protocols and assess feasibility/budget; identify operational challenges and provide resolution plans.
- Lead/organize biomarker and bioanalytical operational meetings; maintain internal databases/document repositories.
- Review study documents (protocols, informed consents, etc.); interpret and explain protocol requirements.
- Contribute to RFPs, CRO/vendor selection, tools/process development, and special projects.
- Support recruiting/hiring and professional development for CPA/CTMA/Sr. CTMA.
- Assist with inputs to protocols, case report forms, informed consents, study plans, presentations; help prepare interim/final study reports; resolve biomarker data discrepancies.
- Ensure work complies with established practices/policies and regulatory requirements; travel may be required.
Basic Qualifications:
- Bachelor’s degree + 5 years’ experience, or Master’s degree + 3 years’ experience.
People Leader Accountabilities:
- Create inclusion; develop talent; empower teams.
Compensation/Benefits (as stated):
- Salary range: $146,540.00–$189,640.00; may be eligible for discretionary bonus/long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions (current employees/contractors):
- Apply via the Internal Career Opportunities portal in Workday.