Exec Director, Regulatory Affairs

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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 POSITION OVERVIEW: The Executive Director, Head of Precision Medicine Regulatory is responsible for defining and leading enterprise-wide regulatory strategy for precision medicine, including companion diagnostics (CDx), in vitro diagnostics (IVD), and biomarker-driven development across all Gilead therapeutic areas. This role ensures seamless integration of diagnostic and therapeutic development strategies from early discovery through global registration and commercialization, while maintaining direct accountability for regulatory strategy and execution of CDx/IVD programs. The position operates at the intersection of enterprise leadership, technical regulatory expertise, and operational execution to enable scalable, compliant, and innovative precision medicine across the Gilead and Kite portfolios. You will develop and execute Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross functional stakeholders across all therapeutic areas and in compliance with the appropriate regulations. You will lead the Regulatory Precision Medicine team and work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide global regulatory guidance for Precision Medicine. You will provide regulatory strategy and support, ensuring communication of a clear vision for the translational discovery, development, and validation of biomarkers in clinical studies. You will provide operational and technical regulatory assistance through all stages of clinical development through global registration for IVD projects. In addition, you may be involved in the identification of predictive biomarkers that may influence drug product(s) clinical development strategy and proof of mechanism. EXAMPLE RESPONSIBILITIES: Represents Regulatory Affairs Precision Medicine as a subject matter expert on cross-functional/cross-regional Regulatory Teams and other Sub-teams involved with the development and validation of IVDs (e.g., Study Management, Clinical, Biomarkers) and presents to senior leadership as required. Develop, lead, communicate, and implement high quality and globally aligned precision medicine regulatory strategies to support Gilead assets from early development through registration. This may involve representing Gilead in key interactions with Health Authorities. Maintains current understanding of global IVD/CDx regulations, assesses and communicates their impact on drug and IVD/CDx development & registration activities, respectively. Provides IVD regulatory input during clinical development to ensure compliance of diagnostics used in therapeutic trials with global and local regulatory requirements (such as US FDA and EU IVDR). Provides regulatory strategy relative to premarket submission, IVD partnering, FDA and other Health Authority interface, regulatory policy, and practice. Leads the preparation and filing of HA briefing books, including coordination and planning for pre-Submission meetings with FDA and IDEs. Provide inputs on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs, device clinical performance study applications and labeling for drug and diagnostic products. Maintain deep expertise in global diagnostic regulations (FDA, EU IVDR, PMDA, NMPA, etc.) and assess impact on development and registration activities. Monitor evolving regulatory landscape and translate into actionable enterprise strategies. Represent Gilead in external forums, including trade organizations and regulatory policy initiatives Manage internal and external stakeholders to advance scientific and technical capabilities to design and execute translational research and precision med

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