Jobs at Zai Lab

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.

Conduct independent, risk‑based QC assessments (on‑site and remote) to verify investigational sites follow protocol, GCP, and company procedures; produce QC reports, track findings, support RCA/CAPA, inspection readiness, training, and process improvements.

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 design and execution of preclinical in vivo PK studies, coordinate with CROs, develop bioanalytical methods for large molecules, perform PK/PD analysis using Phoenix, interpret data to inform discovery and development, and contribute to regulatory study reports and program decision-making.

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.

Support and execute clinical regulatory strategies and submissions (INDs and related filings) for assigned programs. Prepare health authority meeting materials and responses, provide regulatory guidance to cross-functional teams, manage timelines and compliance, identify regulatory risks and mitigation, monitor regulatory intelligence, and contribute to process improvements and inspection-ready documentation.