Clinical Operations Manager (Office Based - South SF 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 Clinical Operations Manager is responsible for the oversight and performance management of Clinical Research Associates (CRAs) to ensure high-quality execution of clinical trials in compliance with ICH-GCP, SOPs, and regulatory requirements. This role serves as the primary operational lead for CRAs and ensures monitoring activities support study timelines, data integrity, and patient safety.

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

CRA Management & Oversight

• Provide oversight and direction for the activities of regional or global CRAs to ensure high-quality monitoring
• Assign CRAs to studies based on experience, workload, and study needs
• Conduct regular 1:1s to review study progress, address issues, and ensure monitoring activities meet expectations
• Facilitate CRA onboarding, training, and ongoing guidance
• Review and approve monitoring reports, trip reports, and follow-up letters as required
• Conduct co-monitoring and/or Sponsor oversight monitoring visits as required

Study Execution & Quality

• Ensure monitoring activities are conducted per protocol, the approved monitoring plan, ICH-GCP, SOPs, and applicable regulations
• Identify and proactively address monitoring risks, site performance issues, and compliance concerns
• Assist Study Manager with the creation and implementation of documents/tools related to study/site monitoring (e.g., Monitoring Plan, eligibility checklist, slot request forms)
• Partner with study teams to resolve site issues, deviations, and inspection readiness gaps
• Escalate quality, compliance, or resourcing risks appropriately
• Operational & Resource Management
• Monitor CRA workload, utilization, and capacity planning
• Support study start-up, enrollment, and close-out activities from a monitoring perspective
• Collaborate with Clinical Operations leadership on resourcing strategies and forecasting
• Participate in audit and inspection readiness activities, including sponsor and regulatory inspections

Cross-Functional Collaboration

• Work closely with Clinical Trial Managers, Project Managers, Data Management, and Safety teams
• Serve as a point of escalation for site-related and monitoring-related issues
• Provide input into monitoring strategies, including risk-based monitoring approaches