Sr Scientist, Inflammation Biomarkers and Translational Research
Gilead Sciences
August 20, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Key Responsibilities
- Lead end-to-end biomarker strategy for one or more clinical programs (early translational through Phase I–III and registrational studies) aligned to program objectives/regulatory expectations.
- Define/implement pharmacodynamic (target engagement, pathway modulation, pathophysiology), MOA, prognostic, predictive, and disease-monitoring biomarkers; manage assay qualification, validation, and transfer to CROs.
- Serve as biomarker lead for cross-functional teams (scientific direction, risk assessment, contingency).
- Support inspection-ready biomarker operations (CRO oversight, vendor management, data quality).
- Design/oversee human-relevant translational studies using primary human samples.
- Lead responder vs nonresponder analyses, pathway interrogation, and reverse translation using clinical/real-world data.
- Integrate multi-omic, spatial, imaging, and clinical datasets to drive decisions.
- Author/review clinical biomarker sections for protocols, IBs, SAPs, and regulatory documents.
- Partner with Clinical, Biostats, and Regulatory to align biomarker strategy with registrational/post-marketing goals.
- Present data publicly; author scientific publications; support health authority interactions (e.g., FDA/EMA).
- Collaborate with external partners/KOLs; provide matrix leadership and mentor.
Qualifications
- Education: PhD or MD/PhD in Immunology, Inflammation Biology, Translational Medicine, or related.
- Experience (Senior Scientist): Typically 5–8+ years post-doc/industry with demonstrated leadership of clinical biomarker strategies.
- Required: strong publication/patent record; deep human immunology/inflammation/fibrotic disease knowledge; proven biomarker strategy design/implementation including assay validation and outsourcing; strong communicator influencing cross-functionally and regulatory/external documents.
- Preferred: liver/gut/fibrosis expertise; led Phase I–III biomarker strategy in regulated settings; health authority biomarker experience; familiarity with flow/mass cytometry, single-cell, spatial, digital pathology; R/Python for biomarker QC/interpretation.
Compensation & Benefits (if applicable)
- Salary range: $169,320.00–$219,120.00; may include discretionary annual bonus, long-term incentives, paid time off, and company-sponsored medical/dental/vision/life.
Application Instructions
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.
- Lead end-to-end biomarker strategy for one or more clinical programs (early translational through Phase I–III and registrational studies) aligned to program objectives/regulatory expectations.
- Define/implement pharmacodynamic (target engagement, pathway modulation, pathophysiology), MOA, prognostic, predictive, and disease-monitoring biomarkers; manage assay qualification, validation, and transfer to CROs.
- Serve as biomarker lead for cross-functional teams (scientific direction, risk assessment, contingency).
- Support inspection-ready biomarker operations (CRO oversight, vendor management, data quality).
- Design/oversee human-relevant translational studies using primary human samples.
- Lead responder vs nonresponder analyses, pathway interrogation, and reverse translation using clinical/real-world data.
- Integrate multi-omic, spatial, imaging, and clinical datasets to drive decisions.
- Author/review clinical biomarker sections for protocols, IBs, SAPs, and regulatory documents.
- Partner with Clinical, Biostats, and Regulatory to align biomarker strategy with registrational/post-marketing goals.
- Present data publicly; author scientific publications; support health authority interactions (e.g., FDA/EMA).
- Collaborate with external partners/KOLs; provide matrix leadership and mentor.
Qualifications
- Education: PhD or MD/PhD in Immunology, Inflammation Biology, Translational Medicine, or related.
- Experience (Senior Scientist): Typically 5–8+ years post-doc/industry with demonstrated leadership of clinical biomarker strategies.
- Required: strong publication/patent record; deep human immunology/inflammation/fibrotic disease knowledge; proven biomarker strategy design/implementation including assay validation and outsourcing; strong communicator influencing cross-functionally and regulatory/external documents.
- Preferred: liver/gut/fibrosis expertise; led Phase I–III biomarker strategy in regulated settings; health authority biomarker experience; familiarity with flow/mass cytometry, single-cell, spatial, digital pathology; R/Python for biomarker QC/interpretation.
Compensation & Benefits (if applicable)
- Salary range: $169,320.00–$219,120.00; may include discretionary annual bonus, long-term incentives, paid time off, and company-sponsored medical/dental/vision/life.
Application Instructions
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.