Jobs at Zai Lab Limited

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.

Lead global safety strategy and risk management for oncology and NSI products across development and post‑marketing. Drive signal detection, benefit‑risk and causality assessment, author key regulatory safety documents, ensure inspection readiness, oversee vendor PV operations, represent safety in governance and regulatory interactions, and present findings to senior leadership.