Director, GI/Liver Biomarkers & Translational Research

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Job Description

Role Overview

Gilead Sciences is seeking an exceptional scientific leader to own end-to-end biomarker and translational strategy across a portfolio of inflammatory bowel disease (IBD) and liver programs. This player-coach role requires recognized scientific expertise, demonstrated productivity and the ability to translate human biology and biomarker evidence into high-impact clinical development, regulatory and portfolio decisions.

The Director will establish the GI/liver biomarker roadmap, lead the most complex and strategically important programs and create leverage across assets by integrating tissue, clinical and multi-omic evidence. The role is expected to support several early and late stage programs, with assignments evolving as portfolio priorities change.

This is a site based role at our global headquarters in Foster City, CA.

Key Responsibilities

·    Own and continuously evolve the integrated GI/IBD and liver biomarker and translational strategy across multiple clinical-stage assets, aligning evidence generation with disease-area, asset, regulatory and portfolio objectives.

·    Lead the most complex programs from early clinical development through Phase II/III, defining decision criteria for target engagement, dose, proof-of-concept, patient selection, response, safety, differentiation and lifecycle opportunities.

·    Provide hands-on scientific leadership for analysis and interpretation of blood, stool, intestinal and liver tissue, endoscopic, histologic, imaging, pathology and multi-omic datasets.

·    Create cross-asset frameworks for forward and reverse translation, including integrated biopsy strategies and analyses of response, resistance, relapse, patient heterogeneity and mechanisms of action.

·    Lead biomarker and translational contributions to protocols, analysis plans, investigator brochures, clinical study reports, briefing documents, regulatory submissions and health authority interactions.

·    Partner with senior leaders across Clinical Development, Research, Clinical Pharmacology, Biostatistics, Bioinformatics, Diagnostics, Clinical Operations and Regulatory; clearly articulate scientific opportunities, uncertainties, trade-offs and recommendations.

·    Oversee biomarker execution, assay and vendor strategy, budgets, timelines, resources and delivery across several concurrent studies; anticipate risks and establish mitigation plans.

·    Establish collaborations with investigators, KOLs, pathologists, consortia and technology partners; represent GI/liver biomarker science at advisory boards, scientific meetings and external forums.

·    Lead publication and evidence-dissemination strategy and maintain an active external scientific presence that strengthens the credibility and differentiation of the portfolio.

·    Develop direct reports and matrix team members, elevate scientific and operational standards, and build reusable capabilities, analytics and best practices across the biomarker organization.

·    Contribute to portfolio prioritization, resource planning and long-range capability strategy; present clear business and scientific cases to governance and executive audiences.

Qualifications and Experience

Basic Qualifications

·    PhD, MD, MD/PhD, PharmD or equivalent advanced degree in immunology, gastroenterology, hepatology, inflammation biology, translational medicine, pharmacology or a related discipline.

·    Typically 12+ years of relevant biotechnology, pharmaceutical, clinical development or human translational research experience, including substantial leadership of clinical-stage biomarker programs.

·    Demonstrated ownership of biomarker and translational strategy across multiple complex programs, with clear examples of influencing dose, proof-of-concept, patient population, go/no-go, regulatory or portfolio decisions.

·    Recognized scientific expertise in human immunology and immune-mediated inflammatory disease, with strong GI/IBD expertise and meaningful knowledge of liver inflammation, injury and/or fibrosis.

·    Proven and sustained scientific productivity and innovation, demonstrated by impactful peer-reviewed publications, patents, influential translational or clinical datasets, invited presentations, external recognition, major development milestones or comparable achievements.

·    Extensive experience with biomarker-rich clinical trials, regulated development, assay externalization, clinical sample operations, complex data integration and regulatory documentation or interactions.

·    Demonstrated ability to lead and influence senior stakeholders, independently structure multiple large-scale assignments, manage resources and communicate cohesive strategy to governance and executive audiences.

·    Track record of mentoring and developing scientists and elevating standards across cross-functional or matrix teams.

Preferred Qualifications

·    Direct leadership of biomarker strategies 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 spanning first-in-human through registrational development and direct participation in FDA, EMA or other health authority interactions.

·    Expertise integrating single-cell, spatial, transcriptomic, proteomic, cellular, genetic, pathology, imaging and clinical data into portfolio decisions.

·    Knowledge of companion diagnostic strategy and evidence requirements.

·    Established relationships with investigators, KOLs, consortia or technology innovators in GI/IBD, liver disease or human translational immunology.

Leadership Profile

A scientifically distinguished, hands-on portfolio leader who sets a compelling direction, operates with rigor and creativity, mobilizes teams through influence, develops talent and consistently converts complex evidence into development and business impact.

The salary range for this position is: $243,100.00 - $314,600.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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