Director, Analytical Development

Gilead Sciences•Foster City, CA

About The Position

The Director of Analytical Development leads a team of scientists responsible for 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, including 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 in a fast-paced environment. The position leads and develops scientists; partners across Research, Regulatory Affairs, Process Chemistry, Formulation, Quality, and Manufacturing; and drives analytical methods, technologies, stability strategies, and technical transfers. It also contributes to portfolio CMC strategy, regulatory submissions and health authority interactions, budget and resource decisions, and a culture of scientific rigor, quality, inclusion, and continuous improvement.

Requirements

Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline with 8+ years of relevant pharmaceutical/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 such as IND/CTA and NDA/MAA, and responding to questions from global health authorities.
Strong cross-functional leadership, oral and written communication skills, and ability to influence at senior levels 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 lab initiatives.

Responsibilities

Lead, mentor, and develop scientists who define end-to-end analytical development strategies across preclinical, clinical, and commercial stages, including impurity control strategies.
Partner with Research, Regulatory Affairs, Process Chemistry, Formulation, Quality, and Manufacturing to align analytical 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.
Serve as a cross-functional team leader; participate in governance and technical review committees; and 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.
Operate within departmental budget and oversee resource allocation and prioritization across a multi-program portfolio.
Foster a culture of scientific rigor, quality, inclusion, and continuous improvement.