Sr Director, Analytical Development
Gilead Sciences
August 22, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Job Summary
The Sr. Director of Analytical Development (AD) provides strategic and technical leadership for analytical development across the pipeline (discovery through marketing approval and product lifecycle management), including end-to-end, phase-appropriate analytical control, method development, and transfer strategies from raw materials through drug product.
Responsibilities
- Lead and develop Directors to Research Associates; design and execute phase-appropriate analytical strategies across raw materials through drug product aligned to clinical plans, business objectives, and regulatory expectations.
- Lead analytical methods/technology strategy and continuous enhancement; translate innovation into robust, scalable commercial testing platforms.
- Provide analytical method transfer leadership to Quality Control and external CDMOs/CTLs.
- Lead characterization of raw materials, intermediates, drug substance, and drug product; partner to select fit-for-purpose technologies for critical quality attribute assignment.
- Partner on AD technology roadmap; deploy innovative technologies to modernize control strategies, accelerate development, improve quality, and enable next-gen manufacturing/testing.
- Manage Module 3 analytical content and data packages for IND/CTA, NDA/MAA/BLA, and lifecycle submissions, including responses to health authority questions.
- Establish/maintain project plans, timelines, budgets, and capacity; manage headcount by program; identify/escalate delivery risks.
- Provide technical leadership per industry standards and global regulatory guidance; make critical scientific decisions.
- Lead/develop diverse scientific teams (hiring, coaching, performance, succession, talent development).
- Represent function in cross-functional governance; build alliances across Drug Substance, Drug Product, Regulatory, Quality, Manufacturing, and external partners.
- Ensure compliance with corporate policies, quality systems, including cGMP expectations.
- Lead cross-functional teams and influence with/without formal authority.
- Engage regulatory agencies as an analytical subject-matter expert when required.
- Build external networks (vendors, consortia, academic/corporate partners).
Qualifications
- Ph.D. (Chemistry/Analytical Chemistry/Chemical Engineering/Biochemistry or related) with 12+ years (or MS/PhD) OR 14+ years with BA/BS; expertise in pharmaceutical/biopharmaceutical analytical development/product characterization.
- Demonstrated senior leadership leading technical organizations and delivering through others.
- Deep expertise in phase-appropriate control strategy and analytical method development and transfer to Quality.
- Working knowledge of cGMP, data integrity, and global regulatory requirements; experience supporting US and international filings.
- Strong communication/presentation skills.
- Small molecule analytical development across lifecycle, including HPLC/UPLC, mass spectrometry, impurities, stability, comparability, validation, and test transfer.
- Proven ability to craft technical/innovation strategies and implement new methodologies.
- Demonstrated ability to solve complex quality/regulatory/scientific problems under aggressive timelines.
Benefits/Compensation
- Salary range: $243,100.00 - $314,600.00; may be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- For current employees and contractors: apply via the Internal Career Opportunities portal in Workday.
The Sr. Director of Analytical Development (AD) provides strategic and technical leadership for analytical development across the pipeline (discovery through marketing approval and product lifecycle management), including end-to-end, phase-appropriate analytical control, method development, and transfer strategies from raw materials through drug product.
Responsibilities
- Lead and develop Directors to Research Associates; design and execute phase-appropriate analytical strategies across raw materials through drug product aligned to clinical plans, business objectives, and regulatory expectations.
- Lead analytical methods/technology strategy and continuous enhancement; translate innovation into robust, scalable commercial testing platforms.
- Provide analytical method transfer leadership to Quality Control and external CDMOs/CTLs.
- Lead characterization of raw materials, intermediates, drug substance, and drug product; partner to select fit-for-purpose technologies for critical quality attribute assignment.
- Partner on AD technology roadmap; deploy innovative technologies to modernize control strategies, accelerate development, improve quality, and enable next-gen manufacturing/testing.
- Manage Module 3 analytical content and data packages for IND/CTA, NDA/MAA/BLA, and lifecycle submissions, including responses to health authority questions.
- Establish/maintain project plans, timelines, budgets, and capacity; manage headcount by program; identify/escalate delivery risks.
- Provide technical leadership per industry standards and global regulatory guidance; make critical scientific decisions.
- Lead/develop diverse scientific teams (hiring, coaching, performance, succession, talent development).
- Represent function in cross-functional governance; build alliances across Drug Substance, Drug Product, Regulatory, Quality, Manufacturing, and external partners.
- Ensure compliance with corporate policies, quality systems, including cGMP expectations.
- Lead cross-functional teams and influence with/without formal authority.
- Engage regulatory agencies as an analytical subject-matter expert when required.
- Build external networks (vendors, consortia, academic/corporate partners).
Qualifications
- Ph.D. (Chemistry/Analytical Chemistry/Chemical Engineering/Biochemistry or related) with 12+ years (or MS/PhD) OR 14+ years with BA/BS; expertise in pharmaceutical/biopharmaceutical analytical development/product characterization.
- Demonstrated senior leadership leading technical organizations and delivering through others.
- Deep expertise in phase-appropriate control strategy and analytical method development and transfer to Quality.
- Working knowledge of cGMP, data integrity, and global regulatory requirements; experience supporting US and international filings.
- Strong communication/presentation skills.
- Small molecule analytical development across lifecycle, including HPLC/UPLC, mass spectrometry, impurities, stability, comparability, validation, and test transfer.
- Proven ability to craft technical/innovation strategies and implement new methodologies.
- Demonstrated ability to solve complex quality/regulatory/scientific problems under aggressive timelines.
Benefits/Compensation
- Salary range: $243,100.00 - $314,600.00; may be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- For current employees and contractors: apply via the Internal Career Opportunities portal in Workday.