Jobs at Zai Lab Limited

Lead targeted, risk‑based QC oversight for clinical trials by planning and conducting on‑site and remote QC assessments, documenting findings, supporting root‑cause analysis and CAPAs, tracking follow‑up, and aiding inspection readiness and training to ensure protocol adherence, patient safety, and data integrity.

Lead independent, risk‑based QC assessments of investigational sites to verify protocol adherence, GCP compliance, and data integrity. Plan and execute on‑site and remote QC visits, document findings, support RCA/CAPA, track follow‑up, aid inspection readiness, train teams, and drive process improvements in partnership with Clinical Operations.

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 risk-based clinical quality control activities including developing QC plans and tools, conducting on-site and remote QC assessments, documenting findings, supporting RCA/CAPA and inspection readiness, training Clinical Operations teams, and tracking follow-up to ensure protocol, GCP, and company procedure compliance.

Lead global clinical trial operations from start-up through close-out, overseeing study strategy, vendor management, budgets, timelines, TMF/EDC/IxRS/CTMS oversight, regulatory compliance (ICH-GCP), and cross-functional team coordination to ensure quality, safety, and on-time delivery.

Lead and coordinate cross-functional regional or global clinical trial teams from start-up through close-out. Oversee operational delivery, vendor management, budgets, timelines, TMF and system support (EDC/IxRS/CTMS). Ensure compliance with ICH-GCP and SOPs, manage risk/quality, support study documents and monitoring, and assist investigator meetings and vendor selection to meet study objectives.