Jobs at Zai Lab

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.

Lead global pharmacovigilance strategy and risk management for Oncology and NSI products across development and post‑marketing. Perform signal detection and evaluation, author regulatory safety documents (DSURs, PBRERs/PSURs, RMPs, REMS components), ensure inspection readiness, oversee vendors, represent safety in governance and regulatory interactions, and collaborate cross-functionally to support benefit‑risk decision making.