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Exec Director, Regulatory Affairs at Gilead Sciences - ApplyBlast

Exec Director, Regulatory Affairs

Gilead Sciences

4 months ago

3.5 on Glassdoor

California, United States

Hybrid

Full Time

Senior

0 applicants

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About this role

The Executive Director, Head of Precision Medicine Regulatory aims to define and lead enterprise-wide regulatory strategies for precision medicine, including companion diagnostics and in vitro diagnostics, across Gilead's therapeutic areas. This senior role ensures the seamless integration of diagnostic and therapeutic development from early discovery through global registration and commercialization, overseeing regulatory execution for CDx/IVD programs. The position requires deep technical expertise and operational leadership to guide biomarker-driven development and maintain compliance with global regulations while collaborating with cross-functional stakeholders.

Responsibilities

Define and lead enterprise-wide regulatory strategy for precision medicine
Ensure seamless integration of diagnostic and therapeutic development strategies
Provide operational and technical regulatory assistance through global registration
Lead the Regulatory Precision Medicine team and manage cross-functional stakeholders
Establish regulatory enterprise frameworks for biomarker and IVD lifecycle management

Skills

Qualifications

PharmD or PhD14+ years relevant experienceBS or BA with 16+ years relevant experienceGlobal regulatory strategy experienceIVD regulatory submission experience

About Gilead Sciences

gilead.com

Headquarters

Foster City, California, United States

Company Size

10001+ employees

Founded

1987

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Gilead Sciences is a biopharmaceutical company dedicated to transforming patient care by advancing therapeutics in areas like HIV, liver disease, cancer, and inflammation. With a strong commitment to innovation, Gilead leads in the research and development of new medicines, aiming to make the world a healthier place. Their portfolio includes breakthrough therapies and ongoing advancements across multiple therapeutic areas, supported by a robust pipeline of clinical trials. Gilead is recognized for its contributions to public health and its efforts to improve access to vital medications.