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 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:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
U.S. Education & Experience
- PharmD/PhD with 14+ years’ relevant experience.
- BA/BS with 16+ years’ relevant experience.
- Significant regulatory, quality, compliance or related experience supporting medicinal products with experience in vitro diagnostic development.
- Understanding of global policy, laws, regulations, and guidelines as they apply to diagnostic development and approval.
- Understanding of molecular technologies and the impact on outcomes and diagnostic results.
- 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.
Knowledge & Other Requirements
- Extensive hands-on experience in CDx/IVD regulatory strategy and submissions, including global filings and co-development with therapeutics.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Demonstrates advanced knowledge of regulatory requirements (including those related to IVDs, notably IVDR) and the role of regulatory affairs in achieving cross-functional drug discovery and development goals and objectives.
- Proven ability to lead both enterprise strategy and program-level execution.
- Demonstrated success influencing cross-functional teams and senior stakeholders in a matrix environment.
- Strong executive presence, analytical thinking, and communication skills.
- In-depth knowledge of relevant health authorities, including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
- Able to represent Gilead to regulatory authorities when managing standard or more routine negotiations.
- Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.
- Ability to lead and influence programs, projects and/or initiatives.
- Strong interpersonal and communication skills with ability to rapidly understand and navigate team dynamics.
- Proven ability to work successfully in a team-oriented, matrixed environment.
- When needed, ability to travel.
