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Foster City, California, United States
Onsite
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
Gilead Sciences is seeking a highly accomplished and 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 is a hands-on scientific leadership role for an individual who combines deep disease biology with demonstrated clinical biomarker development experience and a strong record of scientific productivity.
The Principal Scientist will serve as cross-functional biomarker lead for assigned programs, translating mechanism and human biology into fit-for-purpose biomarker plans from early clinical development through Phase II/III. The role is expected to contribute across various programs, with assignments evolving as portfolio priorities change.
This is a site based role at our global headquarters in Foster City, CA
· Lead end-to-end biomarker strategy for assigned GI/IBD and liver programs, including 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; proactively resolve scientific, quality and operational issues.
· Partner with Clinical Development, Clinical Pharmacology, Biostatistics, Bioinformatics, Pathology, Research, Clinical Operations and Regulatory to embed 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 investigation of mechanisms 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 clearly 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 to reusable biomarker tools, datasets and best practices across the portfolio.
· PhD, MD, MD/PhD, PharmD or equivalent advanced degree in immunology, gastroenterology, hepatology, inflammation biology, translational medicine, pharmacology or a related discipline.
· Typically 8+ 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.
· Proven scientific productivity and creativity, evidenced by a sustained record of impactful 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.
· 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.
A rigorous, creative and execution-oriented scientist who remains close to the data, independently leads complex program work, challenges assumptions constructively, develops others and consistently converts scientific insight into meaningful translational and development impact.
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, 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 Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
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