Jobs 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.

Leads global CMC regulatory strategy and execution for small-molecule and biologic programs across development phases. Oversees IND, CTA, NDA, BLA, and MAA dossier preparation, submissions, agency interactions, risk assessments, and post-approval GMP support. Provides regulatory guidance to cross-functional teams, ensures compliance with international requirements, develops processes, and manages CMC regulatory professionals. Requires extensive scientific and regulatory expertise, bilingual English and Chinese communication, and experience with global health authorities.

Leads Zai Lab’s Clinical Pharmacology function and serves on the Development Leadership Team. Develops clinical pharmacology and model-informed drug development strategies across small molecules, biologics, and other therapeutics. Oversees PK/PD, exposure-response, modeling, simulation, dose projection, bioanalytical activities, CROs, and regulatory submissions and interactions. Partners cross-functionally on global development, portfolio decisions, due diligence, and business development while building a high-performing clinical pharmacology organization.

Lead global pharmacovigilance strategy and risk management for Oncology and Neuroscience & Immunology products across development and post‑marketing. Perform signal detection and evaluation, author regulatory safety documents (DSUR, PBRER, RMP, REMS), ensure inspection readiness, oversee vendors, represent safety in governance and regulatory interactions, and present findings to senior leadership.

Lead and coordinate cross-functional regional or global clinical trials from start-up through close-out. Manage operational delivery, vendor oversight, budgets, timelines, TMF/EDC/IxRS/CTMS support, risk and quality plans, investigator meetings, and ensure compliance with ICH-GCP and company SOPs.

Lead global clinical trial operations from start-up to close-out, managing cross-functional teams, vendors, budgets, timelines, and compliance. Oversee study plans, TMF/QC, EDC/IxRS/CTMS support, vendor selection and oversight, investigator meetings, and ensure adherence to ICH-GCP and company SOPs.

Lead and manage 1-3 drug development and commercialization programs, driving integrated strategy, cross-functional alignment, timelines, budgets, risk mitigation, and senior management communications. Improve portfolio processes and support BD and alliance activities.