Director, GI/Liver Biomarkers & Translational Research

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Role OverviewGilead 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 ProfileA 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. For jobs in the United States:Gilead Sciences Inc. is committed to pro