Jobs at Zai Lab Limited

Leads global clinical trial operations from start-up through closeout, managing study strategy, cross-functional teams, vendors, budgets, timelines, risk, quality, regulatory compliance, documentation, recruitment, and trial systems. Oversees CRO delivery, investigator meetings, TMF quality, and adherence to ICH-GCP and company procedures.

Supports clinical regulatory strategy and execution for biopharmaceutical programs across global regions. Responsibilities include preparing and managing INDs and related submissions, coordinating regulatory timelines, supporting health authority interactions, providing regulatory guidance to cross-functional teams, identifying compliance risks, monitoring regulatory developments, and improving regulatory processes. The role collaborates with Clinical, Nonclinical, Biometrics, Medical Writing, CMC, and other functions.

Leads clinical pharmacology and model-informed drug development strategies for small- and large-molecule programs from early development through registration and lifecycle management. Oversees PK, PK/PD, population PK, PBPK, exposure-response, translational modeling, and clinical pharmacology studies. Supports dose selection, study design, regulatory submissions, health authority interactions, governance decisions, and cross-functional strategy while mentoring scientists and managing internal and external modeling activities.

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 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.

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.