Company Description
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide.
Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage pipeline of innovative drug candidates. Based on our proven track record of success, Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to not only access the Chinese market but also find a long-term strategic partner for global clinical development. Our unique business model builds on our in-licensed assets and innovative partnerships to expand our internal discovery and development capabilities and has created a portfolio of potential best-in-class and/or first-in-class therapies. Zai currently has four products on the market in China
Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed secondary listing on Hong Kong Stock Exchange in September 2020. In 2022, Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges. Since its inception, Zai Lab has expanded significantly with several offices across China. In 2021, Zai Lab established its U.S. Headquarters in Cambridge, Massachusetts. As of January 2022, the Company has a global team of approximately 2000 employees.
Job Description

The Associate Director, Clinical Operations will provide strategic leadership and oversight for the planning, execution, and delivery of global clinical trials from study start-up through close-out. This role is accountable for ensuring that clinical programs are executed in alignment with corporate goals, regulatory requirements (ICH-GCP and local regulations), and industry best practices. The Associate Director will lead cross-functional teams, manage external partners (e.g., CROs, vendors), and drive operational excellence across multiple studies or programs. This position plays a critical role in risk management, resource planning, and ensuring that timelines, budgets, and quality standards are consistently met. This role is based in our South San Francisco, CA office.

• Lead the operational strategy and execution of one or more global clinical trials, ensuring alignment with corporate objectives and regulatory standards.
• Own the end-to-end delivery of assigned clinical trials, including country and site selection, site start-up, contracting, patient recruitment, and retention strategies, ensuring timelines, budgets, and quality metrics are met.
• Drive cross-functional collaboration to develop and finalize critical clinical trial documents and systems, including protocols, informed consent forms (ICFs), budget templates, EDC, IxRS, central/specialty labs, ECG, imaging, PRO specifications, drug supply logistics, biomarker/sample management plans, TMF, and CSRs.
• Develop and implement comprehensive study plans encompassing vendor oversight, risk management, quality assurance, safety monitoring, communication strategies, trial monitoring, and TMF management.
• Ensure timely creation, maintenance, and quality control (QC) of the Trial Master File (TMF) in compliance with regulatory and internal standards.
• Provide oversight and support for clinical systems including EDC, IxRS, and CTMS, ensuring data accuracy and operational efficiency.
• Monitor and manage study budgets, timelines, and milestones; proactively identify risks and implement mitigation strategies.
• Lead financial oversight of assigned studies, including vendor budget management, variance analysis, and resolution planning.
• Drive global vendor selection and management, including participation in the Request for Proposal (RFP) process and contract negotiations.
• Oversee outsourced activities to ensure CRO and vendor performance aligns with contractual obligations and quality expectations.
• Lead the planning and execution of Investigator Meetings in collaboration with cross-functional teams.
• Maintain up-to-date knowledge of relevant therapeutic areas and evolving clinical research practices to inform operational strategies.
• Ensure full compliance with ICH-GCP, regulatory requirements, and company SOPs across all assigned studies.
• Work across several time zones

Qualifications

• Lead the operational strategy and execution of one or more global clinical trials, ensuring alignment with corporate objectives and regulatory standards.
• Own the end-to-end delivery of assigned clinical trials, including country and site selection, site start-up, contracting, patient recruitment, and retention strategies, ensuring timelines, budgets, and quality metrics are met.
• Drive cross-functional collaboration to develop and finalize critical clinical trial documents and systems, including protocols, informed consent forms (ICFs), budget templates, EDC, IxRS, central/specialty labs, ECG, imaging, PRO specifications, drug supply logistics, biomarker/sample management plans, TMF, and CSRs.
• Develop and implement comprehensive study plans encompassing vendor oversight, risk management, quality assurance, safety monitoring, communication strategies, trial monitoring, and TMF management.
• Ensure timely creation, maintenance, and quality control (QC) of the Trial Master File (TMF) in compliance with regulatory and internal standards.
• Provide oversight and support for clinical systems including EDC, IxRS, and CTMS, ensuring data accuracy and operational efficiency.
• Monitor and manage study budgets, timelines, and milestones; proactively identify risks and implement mitigation strategies.
• Lead financial oversight of assigned studies, including vendor budget management, variance analysis, and resolution planning.
• Drive global vendor selection and management, including participation in the Request for Proposal (RFP) process and contract negotiations.
• Oversee outsourced activities to ensure CRO and vendor performance aligns with contractual obligations and quality expectations.
• Lead the planning and execution of Investigator Meetings in collaboration with cross-functional teams.
• Maintain up-to-date knowledge of relevant therapeutic areas and evolving clinical research practices to inform operational strategies.
• Ensure full compliance with ICH-GCP, regulatory requirements, and company SOPs across all assigned studies.
• Work across several time zone