Principal Scientist, GI/Liver Biomarkers & Translational Research

Gilead Sciences • Foster City, CA

3d • Onsite

About The Position

Gilead Sciences is seeking a highly accomplished, 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 hands-on scientific leadership role combines deep disease biology with clinical biomarker development experience and a strong record of scientific productivity. The role serves as cross-functional biomarker lead for assigned programs, translating mechanisms and human biology into fit-for-purpose biomarker plans from early clinical development through Phase II/III. Assignments may evolve as portfolio priorities change. This is a site-based role at Gilead’s global headquarters in Foster City, California.

The Principal Scientist will lead end-to-end biomarker strategy and execution, including assay approaches, clinical sampling and analysis, integrated interpretation of diverse datasets, translational studies, and biomarker contributions to clinical and regulatory documents. The role partners across scientific, clinical, operational and regulatory functions, communicates findings to program teams and governance forums, manages risks and trade-offs, mentors colleagues, and contributes reusable biomarker tools and best practices across the portfolio.

Requirements

• PhD, MD, MD/PhD, PharmD or equivalent advanced degree in immunology, gastroenterology, hepatology, inflammation biology, translational medicine, pharmacology or a related discipline.
• Typically 8 or more years of relevant postdoctoral, biotechnology, pharmaceutical, clinical development or human translational research experience, including meaningful experience in clinical-stage drug development.
• Demonstrated success independently leading biomarker strategy and execution for one or more complex clinical programs, with examples of biomarker evidence informing dose, proof-of-concept, patient population, go/no-go or development decisions.
• Strong scientific depth in human immunology and immune-mediated inflammatory disease, with direct GI/IBD and/or liver disease experience.
• Sustained record of impactful scientific productivity and creativity, evidenced by peer-reviewed publications, patents, clinical or translational datasets, invited presentations, externally recognized collaborations or comparable achievements.
• Hands-on experience with assay development or externalization, clinical sample operations, biomarker data analysis and interpretation, and work in regulated development environments.
• Ability to lead cross-functional workstreams, manage external partners, deliver high-quality work on time, and communicate effectively with scientific and clinical stakeholders.

Nice To Haves

• Direct experience in Crohn’s disease and/or ulcerative colitis, including endoscopic, histologic, intestinal tissue, blood and stool assessments.
• Experience in liver inflammation, fibrosis, noninvasive biomarkers, imaging and/or liver histopathology.
• Experience supporting Phase I through Phase III studies and contributing to health authority interactions or regulatory documents.
• Experience with single-cell or spatial profiling, transcriptomics, proteomics, cytometry, digital pathology, genetics, microbiome analysis or integrated multi-omic approaches.
• Working knowledge of companion diagnostic or in vitro diagnostic considerations.

Responsibilities

• Lead end-to-end biomarker strategy for assigned GI/IBD and liver programs, covering 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, and resolve scientific, quality and operational issues.
• Partner with Clinical Development, Clinical Pharmacology, Biostatistics, Bioinformatics, Pathology, Research, Clinical Operations and Regulatory to integrate 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 investigations 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 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 reusable biomarker tools, datasets and best practices across the portfolio.

Benefits

• Potential eligibility for a discretionary annual bonus.
• Potential eligibility for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical, dental, vision and life insurance plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree