Senior Clinical Trial Manager; Office Based - South SF

Overview

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 LRRC
15 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.

The Senior Clinical Trial Manager will lead, manage and co-ordinate the operational strategy, risk management, and overall execution of clinical trials from study start-up to close out at a global level in accordance with ICH-GCP and applicable local regulations. Collaborate with cross functional stakeholders to ensure deliverables are met in terms of quality, compliance, budget, and timing. This role may work collaboratively on one trial or across several trials to support clinical operations activities.

This position is based in our South San Francisco, CA office.

• Lead and coordinate a cross-functional study team to ensure the clinical trial progresses as planned.
• Accountable for the overall operational strategy and delivery (e.g., country and site selection/start-up, site contracts, patient recruitment and retention, etc.) of assigned clinical trials; ensuring that study-level deliverables are met according to timeline, budget, and quality requirements.
• Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, PRO specifications, drug supply, biomarker/sample management plans, TMF, and CSRs.
• Drafts and implements study plans including; vendor oversight, risk, quality, safety, communication, trial monitoring, and TMF.
• Ensures TMF creation and QC completion.
• Supports EDC, IxRS, and CTMS systems and data maintenance.
• Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions.
• Accountable for the study budget and manages assigned vendor budget(s); communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution.
• Drives the selection of vendors (participates in the Request for Proposal (RFP) process) on a global scale.
• Oversees delegated outsourced activities to ensure CRO and vendor delivery against the contracted scope of work.
• Leads the Investigator Meeting preparation and execution with the support from cross-functional team members
• Stays current on relevant therapeutic area knowledge and clinical research best practices.
• Ensures study adherence to ICH/GCP and company SOPs.

REQUIRED

• Undergraduate degree in a scientific or health-related discipline.
• Minimum of 8 years relevant experience of which 5 years are clinical experience in the pharmaceutical industry, including 3 years in study management or equivalent combination of…