Exec Director, Regulatory Affairs

# **Executive Director, Head of Precision Medicine Regulatory**

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 of 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.

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## **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.

You will develop and execute Precision Medicine regulatory strategies aligned with global drug regulatory strategy, collaborating with cross‑functional stakeholders across all therapeutic areas. You will lead the Regulatory Precision Medicine team, partner closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and work with biomarker teams and global/regional regulatory liaisons to provide global regulatory guidance.

You will provide regulatory strategy and support for biomarker discovery, development, and validation in clinical studies, and deliver operational and technical regulatory guidance through all stages of clinical development and global registration for IVD projects. You may also contribute to identifying predictive biomarkers that influence clinical development strategy and proof of mechanism.

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## **Example Responsibilities**

– **Represents Regulatory Affairs Precision Medicine** as a subject matter expert on cross‑functional and cross‑regional teams involved in IVD development and validation, presenting to senior leadership as needed.
– **Develops, leads, communicates, and implements** high‑quality, globally aligned precision medicine regulatory strategies from early development through registration, including representing Gilead in interactions with Health Authorities.
– **Maintains current understanding of global IVD/CDx regulations** and communicates their impact on drug and diagnostic development and registration.
– **Provides IVD regulatory input during clinical development** to ensure compliance of diagnostics used in therapeutic trials with global and local requirements (e.g., FDA, EU IVDR).
– **Provides regulatory strategy** for premarket submissions, IVD partnering, FDA and Health Authority interactions, regulatory policy, and regulatory practice.
– **Leads preparation and filing of HA briefing books**, including planning for pre‑Submission meetings, IDEs, and providing input on key development documents (protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs, device clinical performance study applications, and labeling).
– **Maintains deep expertise in global diagnostic regulations** (FDA, EU IVDR, PMDA, NMPA, etc.) and assesses their impact on development and registration.
– **Monitors evolving regulatory landscape** and translates changes into actionable enterprise strategies.
– **Represents Gilead in external forums**, including trade organizations and regulatory policy initiatives.
– **Manages internal and external stakeholders** to advance scientific and technical capabilities in translational research and precision medicine.
– **Leads the Regulatory Precision Medicine team**, ensuring globally aligned strategies across therapeutic areas and integration with drug development programs.
– **Hires, develops, and retains top talent**, providing coaching, performance management, and career development.
– **Establishes regulatory frameworks, standards, and best practices** for biomarker, CDx, and IVD development and lifecycle management.
– **Represents Precision Medicine Regulatory in governance forums**, providing strategic direction and decision‑making support.
– **Identifies regulatory risks** and develops mitigation strategies.
– **Supports due diligence, business development, and alliance management** involving biomarkers, IVD, or CDx development.
– **Partners with external diagnostic collaborators** to support co‑development and regulatory success.
– **Ensures consistency, scalability, and regulatory excellence** across early‑ and late‑stage programs.
– **Contributes to process improvements** with significant business impact.
– **Supports or leads training** related to IVD/CDx development and registration.
– **Ensures compliance** with established practices, policies, processes, and regulatory requirements.

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## **Requirements**

We are all different, yet we all use our unique contributions to serve patients. Below are the qualifications and skills we seek for this role.

### **U.S. Education & Experience**

– PharmD/PhD with 14+ years of relevant experience
– BA/BS with 16+ years of relevant experience
– Significant regulatory, quality, compliance, or related experience supporting medicinal products, with experience in IVD development
– Understanding of global policy, laws, regulations, and guidelines related to diagnostic development and approval
– Understanding of molecular technologies and their 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 (strongly preferred)

### **Knowledge & Other Requirements**

– Extensive hands‑on experience in CDx/IVD regulatory strategy and submissions, including global filings and co‑development with therapeutics
– Ability to be flexible, adaptable, and move between projects as needed
– Advanced knowledge of regulatory requirements for IVDs (including IVDR) and the role of regulatory affairs in drug discovery and development
– Proven ability to lead 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 systems, processes, and requirements
– Ability to represent Gilead in regulatory negotiations
– Strong analytical thinking, attention to detail, communication, writing, and project management skills
– Ability to lead and influence programs, projects, and initiatives
– Strong interpersonal and communication skills with the ability to navigate team dynamics
– Ability to travel when needed

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## **Compensation**

**Salary range:** $302,005.00 – $390,830.00
Actual compensation varies based on experience, qualifications, and geographic location.

This position may also be eligible for:

– Annual discretionary bonus
– Stock‑based long‑term incentives
– Paid time off
– Company‑sponsored medical, dental, vision, and life insurance plans*

For additional benefits information, visit:
`https://www.gilead.com/careers/compensation-benefits-and-wellbeing`

\* Eligible employees may participate in benefit plans subject to plan terms and conditions.

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## **Equal Employment Opportunity**

Gilead Sciences Inc. is committed to equal employment opportunities for all employees and applicants, fostering an inclusive environment with diverse perspectives and experiences. Employment decisions will not be based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or expression, veteran status, or other protected characteristics.

Applicants requiring accommodation may contact: [email protected]

Additional notices:
– Know Your Rights poster
– Employee Polygraph Protection Act
– Family and Medical Leave Act

Gilead does not discriminate against employees or applicants who discuss or disclose compensation information, except where access to such information is part of their essential job functions.

We provide a work environment free of harassment and prohibited conduct, supporting individual differences and diversity of thought.

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## **For Current Gilead Employees and Contractors**

Please apply via the Internal Career Opportunities portal in Workday.

Apply here