Associate Director, Clinical Pharmacology & MIDD Lead

Zai Lab; South San Francisco (CA); On-site; USD 198,000 - 257,000; Full time

Job summary

Zai Lab seeks an Associate Director, Clinical Pharmacology & MIDD to lead Clinical Pharmacology for assigned programs, providing scientific leadership in model-informed drug development from early development through registration and lifecycle management for small and large molecules.

Based in South San Francisco, CA, you will collaborate with Clinical Development, Biometrics, Regulatory Affairs, and external partners to ensure data and modeling insights guide dose selection, study design, and

Qualifications

• BS in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, Systems Pharmacology, Biomedical Engineering, or a related discipline with 10 years of experience in clinical pharmacology or pharmacometrics.
• PhD with at least 7 years’ related experience preferred.
• Experience leading modeling activities using NONMEM, Monolix or similar tools.
• Excellent communication and cross-functional leadership across regions.

Responsibilities

• Lead clinical pharmacology and MIDD strategy from early development through lifecycle management for small and large molecules.
• Develop integrated Clinical Pharmacology and Modeling & Simulation plans with quantitative objectives tied to development decisions.
• Design and interpret clinical pharmacology studies and translational PK/PD modeling efforts.
• Ensure regulatory compliance and prepare quantitative sections for INDs, CTAs, and NDAs/BLAs.
• Mentor scientists and collaborate with cross-functional teams and health authorities.

Skills

Clinical Pharmacology

Pharmacometics

MIDD

Pharmacokinetics

Communication

Education

BS in Clinical Pharmacology or related field

PhD preferred

Tools

NONMEM

Monolix

GastroPlus

R

Simcyp

Job description

Zai Lab seeks an Associate Director, Clinical Pharmacology & MIDD to lead Clinical Pharmacology for assigned programs, providing scientific leadership in model-informed drug development from early development through registration and lifecycle management for small and large molecules.

Based in South San Francisco, CA, you will collaborate with Clinical Development, Biometrics, Regulatory Affairs, and external partners to ensure data and modeling insights guide dose selection, study design, and