Director, Analytical Development

Gilead Sciences • Foster City, CA

3d • $226,185 - $292,710

About The Position

The Director of Analytical Development leads a team of scientists responsible for defining analytical strategy and execution across Gilead’s small molecule portfolio, from candidate nomination through commercial approval. The role sets end-to-end analytical development strategy from raw materials through drug product and ensures phase-appropriate analytical control strategies, method development, and analytical technology development. The Director represents Analytical Development on cross-functional CMC teams and governance bodies, combining technical leadership, people management, and business acumen.

Requirements

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline, with 8+ years of relevant pharmaceutical or biotechnology analytical development experience; alternatively, 10+ years with an MS or 12+ years with a BS.
• At least 5 years of people-management experience, including directing managers and leading sizeable teams.
• Expertise in small-molecule analytical development and technology innovation across the full development lifecycle, including early- and late-stage development and commercial support.
• Deep working knowledge of ICH guidelines (Q1, Q2, Q3, Q6A, Q14, M4, and M7), cGMP requirements, and global regulatory expectations.
• Experience contributing to regulatory submissions (IND/CTA, NDA/MAA) and responding to questions from global health authorities.
• Strong cross-functional leadership, oral and written communication skills, and ability to influence senior stakeholders in a matrixed organization.
• High learning agility and ability to understand and apply scientific concepts and methods across areas such as chemistry, pharmaceutical sciences, PAT, and modeling/simulation.
• Strategic thinking and portfolio prioritization; scientific judgment under ambiguity; talent development; stakeholder management; decision-making in cross-functional governance settings; and communication suitable for executive and regulatory audiences.

Nice To Haves

• Experience with complex dosage forms, such as API, fixed-dose combinations, modified release, or sterile injectables, or with specialized modalities.
• Experience with pre-approval inspections (PAI) and commercial lifecycle management, including post-approval changes and ICH Q12.
• Experience building or restructuring analytical organizations, including LIMS/ELN and digital laboratory initiatives.

Responsibilities

• Lead, mentor, and develop scientists who define end-to-end analytical development strategies across preclinical, clinical, and commercial stages, including control strategies for process impurities, degradants, mutagenic impurities, nitrosamines, and elemental impurities.
• Partner with Research, Regulatory Affairs, Process Chemistry, Formulation, Quality, and Manufacturing to align control strategies with process and product understanding and regulatory expectations.
• Drive development, implementation, and continuous improvement of analytical methodologies and technologies, including HPLC/UPLC, GC, dissolution, KF, spectroscopy, and particle-size analysis.
• Guide technical transfer to internal QC laboratories and support method development and technical transfer to external partners, including CDMOs and CTLs.
• Direct development stability strategy and support GMP stability programs, including shelf-life setting and stability data interpretation.
• Champion analytical QbD, enhanced method development, and data-integrity best practices.
• Direct innovation of analytical technologies to improve productivity and increase product and process understanding.
• Lead cross-functional teams; participate in governance and technical review committees; contribute to portfolio-level CMC strategy and risk assessment.
• Author, review, and approve analytical sections of regulatory submissions, including IND/IMPD, NDA/MAA, amendments, and responses to health authority questions.
• Represent Analytical Development in health authority interactions and pre-approval/pre-license inspections.
• Manage departmental budget, resource allocation, and prioritization across a multi-program portfolio.
• Foster a culture of scientific rigor, quality, inclusion, and continuous improvement.

Benefits

• Discretionary annual bonus may be available.
• Discretionary stock-based long-term incentives may be available, with eligibility varying by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.
• Benefits package, subject to applicable plan terms and conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree