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Job Description
Role Overview
Gilead Sciences is seeking a highly accomplished Senior Scientist to join the Biomarkers and Translational Inflammation Group in the research organization. This role will provide scientific leadership in the design, development, and execution of biomarker and translational strategies to support clinical programs across inflammatory and fibrotic diseases, with increasing accountability through late-stage (Phase II–III) development.
The successful candidate will serve as a biomarker and translational science leader for one or more programs, working closely with Clinical Development, Clinical Pharmacology, Biostatistics, Bioinformatics, Regulatory, and external partners. This position requires deep expertise in human immunology and inflammation, demonstrated success supporting registrational studies, and experience interacting with global health authorities.
Experience in primary biliary cholangitis (PBC), immune mediated liver disease, and/or hepatic inflammation/fibrosis is a strong plus.
This is a onsite based position at our global headquarters in Foster City, CA.
Key Responsibilities
- Lead the end-to-end biomarker strategy for one or more clinical programs, from early translational research through Phase III and registrational studies, aligned with program objectives and regulatory expectations.
- Define and implement fit for purpose PD, RO, MOA, prognostic, predictive, and disease‑monitoring biomarkers, including assay qualification, validation, and transfer to CROs.
- Serve as the biomarker lead for cross-functional program teams, providing scientific direction, risk assessment, and contingency planning.
- Design and oversee human-relevant translational studies using primary blood and tissue samples (including liver, gut, lung, skin, synovium).
- Lead responder vs. nonresponder analyses, pathway interrogation, and reverse‑translation efforts using clinical and real-world data.
- Integrate multi-omic, spatial, imaging, and clinical datasets to generate actionable insights and inform program decisions.
- Author and review clinical biomarker sections for protocols, IBs, SAPs, and regulatory documents, including support for Phase III trials.
- Partner with Clinical, Biostats, and Regulatory to ensure biomarker strategies are aligned with registrational and post‑marketing objectives.
- Support inspection-ready biomarker operations, including CRO oversight, vendor management, and data quality assurance.
- Present clinical biomarker data at conferences and investigator meetings, and author biomarker research focused scientific publications.
- Contribute to and participate in health authority interactions (e.g., FDA, EMA), including briefing documents, responses, and meetings, representing biomarker and translational strategy.
- Engage with external collaborators, consortia, and KOLs, and represent the organization in scientific and advisory forums as appropriate.
- Provide matrix leadership across functions; mentor junior scientists and contribute to scientific capability building within the group.
- Help shape portfolio-level biomarker strategy, standards, and innovation initiatives.
- Influence decision making through clear scientific communication, data‑driven recommendations, and strong stakeholder engagement.
Qualifications & Experience
Education
- PhD in Immunology, Inflammation Biology, Translational Medicine, or related discipline.
Experience
- Senior Scientist: Typically, 5–8+ years of relevant post‑doctoral and industry experience with demonstrated leadership of biomarker strategies for clinical programs.
Required Expertise
- Deep understanding of human immunology, inflammation, and/or fibrotic disease biology with hands-on mindset balanced with a strategic perspective.
- Strong record of scientific contributions, including high profil