Sr Director, Analytical Development

Responsibilities

• Provide strategic and technical leadership for analytical development across the pipeline, from discovery through marketing approval and product lifecycle management.
• Lead and develop a diverse organization of scientists, responsible for designing and executing phase-appropriate analytical strategies.
• Drive the development and enhancement of analytical methods and technologies to create robust, scalable commercial testing platforms.
• Oversee analytical method transfer strategies to internal Quality Control teams and external CDMOs or contract laboratories.
• Partner with Regulatory Affairs to manage Module 3 analytical content and data packages for IND, NDA, BLA, and lifecycle submissions.
• Manage project plans, timelines, budgets, and resource allocation to ensure pipeline advancement.
• Represent the analytical function in cross-functional governance forums and engage with regulatory agencies as a subject-matter expert.

Requirements

• Ph.D. in Chemistry, Analytical Chemistry, Chemical Engineering, Biochemistry, or a related scientific discipline.
• 12+ years of experience with a graduate degree (MS or PhD) or 14+ years with a BA/BS.
• Deep expertise in pharmaceutical analytical development and product characterization.
• Proven experience in small molecule analytical development, including chromatography (HPLC/UPLC), mass spectrometry, and method validation.
• Strong working knowledge of cGMP, data integrity, and global regulatory requirements.
• Demonstrated senior leadership experience managing highly technical organizations and delivering results through others.

About the Company

Gilead Sciences is a research-based biopharmaceutical company that has tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer for more than 35 years. We work relentlessly to develop therapies that improve lives and ensure global access to life-changing scientific innovations.