Teams at Zai Lab Limited

Leads global clinical trial operations from start-up through closeout, managing study strategy, cross-functional teams, vendors, budgets, timelines, risk, quality, regulatory compliance, documentation, recruitment, and trial systems. Oversees CRO delivery, investigator meetings, TMF quality, and adherence to ICH-GCP and company procedures.

Supports clinical regulatory strategy and execution for biopharmaceutical programs across global regions. Responsibilities include preparing and managing INDs and related submissions, coordinating regulatory timelines, supporting health authority interactions, providing regulatory guidance to cross-functional teams, identifying compliance risks, monitoring regulatory developments, and improving regulatory processes. The role collaborates with Clinical, Nonclinical, Biometrics, Medical Writing, CMC, and other functions.

Leads clinical pharmacology and model-informed drug development strategies for small- and large-molecule programs from early development through registration and lifecycle management. Oversees PK, PK/PD, population PK, PBPK, exposure-response, translational modeling, and clinical pharmacology studies. Supports dose selection, study design, regulatory submissions, health authority interactions, governance decisions, and cross-functional strategy while mentoring scientists and managing internal and external modeling activities.