Head of Clinical Pharmacology

Zai Lab (US) LLC•South San Francisco, CA

23h•$283,000 - $411,000•Onsite

About The Position

Zai Lab is seeking an experienced Clinical Pharmacology leader to lead the Clinical Pharmacology function and serve as a key member of the Development Leadership Team. This role is responsible for clinical pharmacology strategy, model-informed drug development, and regulatory support across Zai Lab’s portfolio, supporting global development of small molecules, biologics, and other innovative therapeutics. This role is based in our South San Francisco, CA office.

Requirements

PhD in Clinical Pharmacology, Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or a related field, with 12 years’ relevant experience in drug development, including industry, regulatory, or other related settings; or equivalent combination of higher education, training and experience.
Strong knowledge of GLP, GCP, ICH, and relevant global regulatory guidelines is required.
Must have the highest personal values and ethical standards.

Nice To Haves

Demonstrated leadership in clinical pharmacology and drug development.
Demonstrated knowledge of clinical pharmacology, non-clinical packages, and regulatory requirements supporting global drug development, including first-in-human studies, dose justification, registration programs, and post-approval commitments.
Demonstrated experience applying model-informed drug development approaches, including population PK, exposure-response analyses, PBPK, and other quantitative methods to support development and regulatory decision-making.
Experience leading clinical pharmacology contributions to regulatory submissions and interactions with global health authorities, including FDA, EMA, CDE, and other regulatory agencies.
Experience managing external partners, CROs, and vendors supporting clinical pharmacology, bioanalytical, and modeling activities.
Strong communication and influencing skills with the ability to work effectively across cross-functional teams and senior leadership.
Proven leadership experience in building and developing high-performing teams, driving organizational capability, and leading cross-functional collaboration in a matrix environment.
Experience supporting business development evaluations, due diligence activities, and external collaborations is preferred.
Experience in biotech and cross-regional collaboration with Asia/China.

Responsibilities

Provide strategic leadership for the Clinical Pharmacology function, including clinical pharmacology, modeling and simulation, and bioanalytical activities across Zai Lab’s portfolio.
Develop and implement clinical pharmacology strategies to support global development and registration of small molecules, biologics, and other innovative therapeutics.
Serve as the clinical pharmacology lead for development programs and contribute to key development, regulatory, and portfolio decisions.
Lead clinical pharmacology assessments and quantitative analyses, including PK/PD, exposure-response evaluation, modeling and simulation, and human dose projection to support development and regulatory strategies.
Partner closely with Clinical Development, Translational Sciences, DMPK, Regulatory Affairs, Biometrics, and other cross-functional teams to ensure effective integration of clinical pharmacology into development plans.
Oversee the quality, execution, interpretation, and reporting of clinical pharmacology activities conducted internally and through CROs, alliance partners, and external collaborators.
Lead the preparation of clinical pharmacology components of regulatory submissions and regulatory interactions, including INDs, CTAs, protocols, IBs, briefing documents, and responses to health authority inquiries.
Evaluate and implement appropriate clinical pharmacology, bioanalytical, and quantitative science technologies and capabilities to support portfolio needs.
Build and develop a high-performing Clinical Pharmacology organization through talent development, succession planning, and capability building.
Provide clinical pharmacology leadership for business development evaluations, due diligence activities, and external collaborations.