Senior Medical Director, Early Clinical Development, Immunology (Office Based - SF, San Diego or Cambridge)

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 Senior Medical Director will lead early-stage clinical development programs in Immunology, overseeing the design and execution of Phase I and II trials and will serve as the clinical translational leader bridging the preclinical/discovery efforts to further clinical exploration. Responsibilities include independently contributing to and executing on the clinical strategy and collaborating with cross-functional teams to advance novel therapies from first-in-human studies through proof-of-concept. The role plays a key part in shaping development plans, supporting regulatory submissions, and representing Zai Lab externally.

This role is based in one of our offices: South San Francisco, CA; San Diego, CA; or Cambridge, MA.

• Clinical Trial Leadership: Provide medical leadership for the design and execution of early-stage clinical trials, including first-in-human and proof-of-concept studies. Collaborate closely with clinical operations to ensure trials are conducted in alignment with scientific objectives, patient safety standards, and regulatory requirements.
• Medical Monitoring: Oversee patient safety, protocol adherence, and clinical data review for early-phase trials by either serving directly as the Medical Monitor or providing oversight. Responsibilities include offering medical input on eligibility, adverse events, and protocol deviations, and collaborating with investigators and internal teams to ensure high-quality trial execution.
• Strategic Input: Contribute expert medical and scientific input to clinical development plans, study protocols, investigator brochures, and regulatory submissions.
• Cross-functional Collaboration: Partner with translational medicine, clinical operations, clinical pharmacology, regulatory affairs, pharmacovigilance, and biostatistics to ensure seamless execution of clinical programs and to align business and clinical objectives.
• External Representation: Represent Zai Lab in interactions with investigators, key opinion leaders, regulatory authorities, and external collaborators.
• Data Analysis & Interpretation: Analyze clinical trial data and real-world evidence to identify trends, assess efficacy and safety signals, and support data-driven decision-making. Collaborate with cross-functional teams to translate findings into actionable insights that inform clinical strategy, regulatory s