Teams at Zai Lab

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.