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

Job Description

Job Description

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 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

REQUIRED

PREFERRED

Additional Information

The pay range for this position at commencement of employment is expected to be between $191K and $212K / year. Base pay offered may vary depending on multiple individualized factors, including location, job-related knowledge, skills, education and experience. The total compensation package for this position may also include other elements, including corporate bonus and equity awards.  In addition Zai Lab offers a robust benefits package which includes comprehensive health insurance, 401(k) with company match, family advocacy programs, and various paid time off benefits, such as vacation, sick time, and parental leave. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary as well as any other discretionary payment and benefits at any time, including for reasons related to individual performance, Company or individual department / team performance, and market factors.

At Zai, we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 58% of our employees are women and 54% of our management positions are held by women. We are committed to the health of patients and our planet. That’s why our environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life” is integrated within our business.

Disclaimer : This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context.  Privacy Notice available upon request.