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

12 Sep 2025
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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 submissions, and program advancement.Regulatory Support: Contribute to IND submissions, briefing documents, and responses to health authority queries. Support risk management planning and mitigation strategies throughout the development lifecycle.Business Development: Provide clinical expertise to support licensing opportunities, partnerships, and due diligence activities.Stakeholder Engagement: Build strong relationships, challenge ideas constructively, and drive impactful decision-making based on scientific evidence.Scientific Leadership: Stay abreast of emerging trends in immunology and early drug development to inform strategy and innovation.

  • ID: #54487729
  • State: South Dakota Southsanfrancisco 00000 Southsanfrancisco USA
  • City: Southsanfrancisco
  • Salary: USD TBD TBD
  • Job type: Full-time
  • Showed: 2025-09-12
  • Deadline: 2025-11-11
  • Category: Et cetera
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