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, from Directors to Research Associates, ensuring alignment with clinical development plans and business objectives.
• Drive the development and execution of phase-appropriate analytical control, method development, and transfer strategies for raw materials through drug products.
• Partner with Technical Development, Regulatory Affairs, Quality, and Manufacturing to advance pipeline programs and manage Module 3 analytical content for regulatory submissions.
• Establish and maintain project plans, timelines, budgets, and resource/capacity plans while managing headcount assignments.
• Represent the function in cross-functional governance forums and engage with regulatory agencies as an analytical subject-matter expert when required.

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, specifically in small molecule analytical development across the lifecycle.
• Proven experience in phase-appropriate control strategy development and analytical method transfer to Quality organizations.
• Strong working knowledge of cGMP, data integrity expectations, and global regulatory requirements.
• Technical proficiency in chromatography (HPLC/UPLC), mass spectrometry, impurity methods, stability, and method validation.
• Demonstrated senior leadership experience leading highly technical organizations and delivering results through others.

About the Company

Gilead 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 help improve lives and ensure access to these therapies across the globe.