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Job Description
Role Overview
Gilead Sciences is seeking a highly accomplished and scientifically rigorous Principal Scientist to lead biomarker and translational strategy and execution for complex clinical-stage programs across inflammatory bowel disease (IBD) and liver disease. This is a hands-on scientific leadership role for an individual who combines deep disease biology with demonstrated clinical biomarker development experience and a strong record of scientific productivity.
The Principal Scientist will serve as cross-functional biomarker lead for assigned programs, translating mechanism and human biology into fit-for-purpose biomarker plans from early clinical development through Phase II/III. The role is expected to contribute across various programs, with assignments evolving as portfolio priorities change.
This is a site based role at our global headquarters in Foster City, CA
Key Responsibilities
· Lead end-to-end biomarker strategy for assigned GI/IBD and liver programs, including target engagement, pharmacodynamic, mechanism-of-action, disease activity, safety, predictive and treatment-response biomarkers.
· Translate program hypotheses into decision-focused clinical biomarker plans, sampling strategies, assay requirements, analysis plans and interpretation frameworks.
· Provide hands-on scientific leadership for blood, stool, intestinal and liver tissue, endoscopic, histologic, imaging and multi-omic biomarker approaches.
· Lead assay selection, characterization, qualification or validation, outsourcing, technology transfer and CRO/vendor oversight; proactively resolve scientific, quality and operational issues.
· Partner with Clinical Development, Clinical Pharmacology, Biostatistics, Bioinformatics, Pathology, Research, Clinical Operations and Regulatory to embed biomarker objectives into protocols and development plans.
· Lead integrated interpretation of clinical, pathology, imaging, transcriptomic, proteomic, cellular, spatial and other high-dimensional datasets; generate testable hypotheses and actionable development recommendations.
· Drive forward and reverse translational analyses, including responder/non-responder studies and investigation of mechanisms of response, resistance, relapse and patient heterogeneity.
· Author or provide biomarker content for protocols, investigator brochures, analysis plans, clinical study reports, briefing documents, regulatory submissions, publications and presentations.
· Communicate complex findings clearly to program teams and governance forums; manage risks and trade-offs and influence decisions with limited guidance.
· Mentor colleagues, establish high scientific and executional standards, and contribute to reusable biomarker tools, datasets and best practices across the portfolio.
Qualifications and…