Jobs at Zai Lab

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, tracking follow-up to closure, and training Clinical Operations teams to improve protocol adherence and data integrity.

Lead risk‑based QC for clinical trials through on‑site and remote assessments. Develop QC plans and tools, conduct site visits, document findings, track follow‑up and CAPAs, support inspection readiness, perform trend analysis, and deliver training and process improvements while collaborating with Clinical Operations teams.

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 execute risk‑based clinical quality control (QC) assessments of investigational sites to verify protocol adherence, GCP, and company procedures. Plan and perform on‑site and remote QC reviews, produce QC reports, track findings and follow‑up actions, support RCA/CAPA and inspection readiness, provide training and process improvement recommendations, and collaborate with Clinical Operations teams to resolve compliance and data integrity issues.

Lead global clinical trial operational strategy and execution from start-up to close-out. Manage cross-functional teams, vendor selection/oversight, budgets, timelines, and compliance with ICH-GCP and company SOPs. Support systems (EDC, IxRS, CTMS), TMF creation/QC, risk/quality plans, investigator meetings, and study documentation to ensure timely, on-budget, high-quality trial delivery.

Manage operational delivery of clinical trials from start-up to close-out, leading cross-functional teams, overseeing vendors/CROs, supporting systems (EDC/IxRS/CTMS/TMF), tracking budgets and timelines, ensuring ICH-GCP compliance, and supporting study document and monitoring activities.