Teams at Zai Lab

Leads global clinical trial operations from start-up through closeout, managing cross-functional teams, vendors, budgets, timelines, risks, quality, compliance, site activities, study documents, and clinical systems. Ensures trials adhere to ICH-GCP, company procedures, and local regulations while coordinating recruitment, investigator meetings, outsourced activities, and study-level deliverables.

Supports clinical regulatory strategy and execution for biopharmaceutical development programs across regions. Responsibilities include preparing and managing INDs and related submissions, coordinating regulatory timelines, supporting health authority interactions, providing regulatory guidance to cross-functional teams, ensuring compliance, identifying risks, monitoring regulatory developments, and improving regulatory processes.

Leads clinical pharmacology and model-informed drug development strategies for small- and large-molecule programs from early development through registration and lifecycle management. Directs PK, PK/PD, population PK, exposure-response, PBPK, translational modeling, and other quantitative analyses; supports dose selection, study design, regulatory submissions, and health authority interactions. Provides cross-functional scientific leadership, mentors scientists, oversees internal and external modeling activities, and contributes to governance, portfolio reviews, and business development.