Exec Director, Regulatory Affairs

About the role

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.

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.
• Lead 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 medicine across all therapeutic areas.
• Lead a group of talented Regulatory Precision Medicine team members in defining and implementing globally aligned precision medicine regulatory strategies across all therapeutic areas, ensuring integration of the strategy with drug development programs and partners.
• Hire, develop, and retain top talent; provide coaching, performance management, and career development.
• Establish regulatory enterprise frameworks, standards, and best practices for biomarker, CDx, and IVD development and lifecycle management.
• Represent Precision Medicine Regulatory in Asset Teams and other team governance forums, providing strategic direction and decision-making support.
• Identify regulatory risks and develop mitigation strategies across programs.
• Support due diligence, business development, and alliance management activities involving biomarkers, IVD, or CDx development.
• Partner with external diagnostic collaborators to support co-development and regulatory success.
• Ensure consistency, scalability, and regulatory excellence across early- and late-stage programs.
• Contributes to local and/or global process improvements which have a significant impact on business.
• Support or lead training related to the IVD/CDx development & registration activities.
• Ensures compliance with established practices, policies, processes, and any regulatory or other requirements.

Requirements

• U.S. Education & Experience: PharmD/PhD with 14+ years’ relevant experience or BA/BS with 16+ years’ relevant experience.
• Experience: Significant regulatory, quality, compliance or related experience supporting medicinal products with experience in vitro diagnostic development.
• Understanding: Understanding of global policy, laws, regulations, and guidelines as they apply to diagnostic development and approval.
• Knowledge: Extensive hands-on experience in CDx/IVD regulatory strategy and submissions, including global filings and co-development with therapeutics.
• Skills: Demonstrated experience supporting global regulatory strategy across multiple development stages, experience authoring and implementing processes, experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.