Jobs at Zai Lab Limited

Leads global CMC regulatory strategy and execution for small-molecule and biologic programs across development phases. Oversees regulatory dossier preparation, submissions, agency interactions, risk assessments, post-approval GMP activities, and compliance with international guidelines. Provides strategic guidance to cross-functional teams, manages regulatory CMC professionals, develops internal processes, and supports interactions with NMPA, FDA, EMA, and other health authorities.

Leads Zai Lab’s Clinical Pharmacology function and provides strategy across global drug development programs involving small molecules, biologics, and innovative therapeutics. Oversees PK/PD, exposure-response, modeling and simulation, dose projection, bioanalytical activities, regulatory submissions, CROs, external collaborations, and health-authority interactions. Partners with cross-functional development teams, supports business development and due diligence, and builds a high-performing clinical pharmacology organization.

Lead independent, risk‑based quality control (QC) assessments of investigational sites to verify protocol adherence, GCP compliance, and data integrity. Develop QC plans/tools, conduct on‑site and remote reviews, document findings, support RCA/CAPA, track remediation, and contribute to inspection readiness, training, and process improvement in partnership with Clinical Operations teams.

Lead global pharmacovigilance strategy and safety evaluation for Oncology and NSI products across development and post‑marketing. Perform signal detection and evaluation, author key regulatory safety documents, ensure inspection readiness, manage vendor PV activities, represent safety in governance and regulatory interactions, and provide evidence-based benefit‑risk recommendations to senior leadership.

Lead global clinical trial operations from start-up to closeout, managing cross-functional teams, operational strategy, vendor oversight, budgets, timelines, TMF/EDC/IxRS/CTMS systems, and compliance with ICH-GCP and company SOPs to ensure quality delivery.

Lead and coordinate cross-functional regional/global clinical trial teams from start-up to closeout. Manage operational delivery, site selection/start-up, vendor/CRO oversight, budgets, timelines, risk, and TMF/EDC/IxRS/CTMS data activities. Ensure ICH-GCP and SOP compliance, support study document development, and drive patient recruitment and retention.

Senior DMPK scientist responsible for designing and overseeing preclinical PK studies, coordinating with CROs, developing bioanalytical methods for large molecules, performing PK/PD analysis (Phoenix), interpreting data to inform discovery and development, and contributing to study reports and regulatory documents.

Lead and manage 13 programs through development and commercialization. Develop and execute integrated development strategies, drive cross-functional planning (timelines, budgets, risks), monitor milestones, ensure program data quality, resolve issues, lead governance and stakeholder communications, support BD and alliance management, and improve departmental processes and tools.

Support clinical regulatory strategy and execution for assigned programs: prepare and manage INDs and submissions, develop meeting materials, provide regulatory guidance to cross‑functional teams, ensure compliance, identify risks, monitor regulatory intelligence, and improve regulatory processes.