Senior Medical Director, Oncology Clinical Development

Job Description

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%.

Qualifications

REQUIRED

• MD with board certification in Oncology, Hematology-Oncology, or a related specialty, and five years of clinical development experience, with a focus on late-stage oncology trials.

PREFERRED

• Proven track record as a Medical Monitor for pivotal trials and successful regulatory submissions.
• Deep understanding of oncology drug development, clinical endpoints, and regulatory pathways.
• Proven ability to lead cross-functional teams and manage complex clinical programs.
• Clinical practice experience or experience as an investigator is a plus.
• Excellent leadership, strategic thinking, and communication skills.
• Strong collaboration skills to effectively interact with internal and external stakeholders.
• Demonstrated commitment to high personal values and ethical standards.

Additional Information

The pay range for this position at commencement of employment is expected to be between $292K and $409K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. 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 or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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.