At Gilead, weāre creating a healthier world for all people. For more than 35 years, weāve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer ā 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 worldās biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
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Every member of Gileadās 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 weāre looking for the next wave of passionate and ambitious people ready to make a direct impact.
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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
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This is a onsite based position at our global headquarters in Foster City, CA.
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 diseaseāmonitoring 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 reverseātranslation 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 postāmarketing 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, dataādriven recommendations, and strong stakeholder engagement.
PhD in Immunology, Inflammation Biology, Translational Medicine, or related discipline.
Senior Scientist: Typically, 5ā8+ years of relevant postādoctoral and industry experience with demonstrated leadership of biomarker strategies for clinical programs.
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 profile publications and/or patents.
Proactive problem-solver with proven experience designing and implementing clinical biomarker strategies, including assay validation and outsourcing.
Demonstrated ability to support Phase IIāIII clinical trials and work within regulated development environments.
Prior experience interacting with health authorities on biomarker related topics is required.
A clear and effective communicator with the ability to influence across functions, with experience contributing to regulatory and externalāfacing documents.
Experience in primary biliary cholangitis (PBC), immune mediatedāliver disease, and/or hepatic inflammation/fibrosis.
Familiarity with high dimensional platforms (flow/mass cytometry, singleācell, spatial, digital pathology).
Working knowledge of data analysis tools (e.g., R, Python) for biomarker QC and interpretation.
This position offers the opportunity to directly influence late-stage development and regulatory success for therapies addressing serious inflammatory and fibrotic diseases. You will operate at the intersection of human biology, clinical development, and regulatory science, with clear visibility and impact across the portfolio.
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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.
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability,Ā genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Ti
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