Associate Director, Clinical Operations - Oncology (Compound Lead) (Office Based 3X/wk)

Company Description

Zai Lab is a patient-focused, innovative, commercial-stage, global biopharmaceutical company based in China and the United States. We are dedicated to discovering, developing, and commercializing best-in-class and first-in-class therapies that address medical conditions with significant unmet needs in oncology, immunology, neuroscience, and infectious disease. Guided by innovation and driven by purpose, our mission is to leverage our expertise and resources to make a lasting, positive impact on human health worldwide.

Zai Lab’s global team of 2,100 talented professionals includes industry leaders and professionals dedicated to advancing novel therapies to patients. With headquarters in Cambridge, Massachusetts, and Shanghai, and teams in the U.S., China and Europe, we collaborate across time zones to deliver meaningful impact where it’s needed most.

Founded in 2014 by Dr. Samantha Du, Zai Lab was purpose-built to become a leading global biopharma, combining scientific innovation, operational scale, and strong execution. Our global pipeline features ZL-1310, a DLL3 antibody-drug conjugate (ADC) with best-in-class and first-in-class potential in small cell lung cancer, now in clinical trials. At the same time, our R&D team is progressing several other global programs into the clinic, including ZL-1503, a bispecific IL-13/IL-31 antibody for atopic dermatitis, and ZL-6201, an LRRC15 ADC for solid tumors.

In China, we’ve earned a reputation as a partner of choice for leading global biopharmaceutical companies, leveraging our proven commercial infrastructure and clinical trial capabilities to accelerate market access to our innovative products. Due to its large population, China is the second largest pharmaceutical market in the world. Our unique business model combines in-licensed assets with strategic partnerships, leveraging our in-house research capabilities to build a regional portfolio of late-stage, potential best-in-class and first-in-class therapies. Today, with eight products on the market in China, we are delivering meaningful impact for patients and building opportunities for talented professionals to shape the future of medicine.

Zai Lab is publicly traded with dual-primary listings on both the Nasdaq Stock Market and the Hong Kong Stock Exchange, underscoring our commitment to transparency, global reach, and long-term growth.

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