The Senior Medical Director will lead late-stage clinical development programs in Oncology, including pivotal Phase III trials and registration studies. Responsibilities include independently contributing to and executing on the clinical strategy, serving as Medical Monitor, supporting regulatory submissions and commercialization efforts, and collaborating and leading cross-functional teams. The role plays a key part in scientific oversight to ensure successful execution and advancement of oncology assets and representing Zai Lab externally.This role is based in our South San Francisco office. Clinical Trial Leadership: Provide medical leadership for the design and execution of late-stage clinical trials, including pivotal and confirmatory studies. Collaborate closely with clinical operations to ensure trials are conducted in alignment with scientific objectives, patient safety standards, and regulatory requirements.Medical Monitoring: Serve as Medical Monitor for Phase III and registration trials, ensuring patient safety, protocol compliance, and timely medical oversight. Review safety data, support data monitoring activities, and act as the primary medical contact for study teams and investigators.Strategic Input: Contribute expert medical and scientific leadership to clinical development strategies, regulatory submissions, and lifecycle planning.Cross-functional Collaboration: Work closely with regulatory affairs, clinical operations, pharmacovigilance, biostatistics. medical affairs, and commercial teams to align clinical and business 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.Lifecycle Management: Develop strategies for label expansion, post-marketing commitments, and long-term product differentiation.Regulatory Support: Lead the preparation of regulatory documents, participate in health authority interactions globally, and contribute to 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: Maintain up-to-date knowledge of oncology trends, the competitive landscape, and regulatory changes to inform clinical strategy.Ability to work across several time zones and travel up to 30%.
