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About the Role

Lead late-stage clinical development programs in Oncology, including pivotal Phase III trials and registration studies. This role involves contributing to and executing clinical strategy, serving as Medical Monitor, supporting regulatory submissions and commercialization, and leading cross-functional teams. You will provide scientific oversight for oncology assets and represent Zai Lab externally.

Responsibilities

• 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 align with scientific objectives, patient safety standards, and regulatory requirements.
• 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.
• Contribute expert medical and scientific leadership to clinical development strategies, regulatory submissions, and lifecycle planning.
• Work closely with regulatory affairs, clinical operations, pharmacovigilance, biostatistics, medical affairs, and commercial teams to align clinical and business objectives.
• Represent Zai Lab in interactions with investigators, key opinion leaders, regulatory authorities, and external collaborators.
• 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.
• Develop strategies for label expansion, post-marketing commitments, and long-term product differentiation.
• Lead the preparation of regulatory documents, participate in health authority interactions globally, and contribute to risk management planning and mitigation strategies.
• Provide clinical expertise to support licensing opportunities, partnerships, and due diligence activities.
• Build strong relationships, challenge ideas constructively, and drive impactful decision-making based on scientific evidence.
• 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%.

Requirements

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

Skills

• Oncology Drug Development
• Clinical Trial Design
• Medical Monitoring
• Regulatory Submissions
• Cross-functional Team Leadership
• Data Analysis
• Strategic Planning
• Stakeholder Engagement

Location

• South San Francisco

Work Type

• Full-time
• Travel up to 30%

Experience Level

• Senior

Education Level

• MD with board certification in Oncology, Hematology-Oncology, or a related specialty

Salary/Compensations

• $292K - $409K/year

Benefits

• Sign-on bonus
• Restricted stock units
• Discretionary awards
• Medical benefits
• Financial benefits
• 401(k) eligibility
• Paid time off (vacation, sick time, parental leave)

About the Company

• Zai Lab is a patient-focused, innovative, commercial-stage, global biopharmaceutical company based in China and the United States.
• Dedicated to discovering, developing, and commercializing best-in-class and first-in-class therapies in oncology, immunology, neuroscience, and infectious disease.
• Mission: Leverage expertise and resources to make a lasting, positive impact on human health worldwide.
• Global team of 2,100 professionals with headquarters in Cambridge, Massachusetts, and Shanghai, and teams in the U.S., China, and Europe.
• Founded in 2014 by Dr. Samantha Du with a purpose to become a leading global biopharma.
• Publicly traded with dual-primary listings on Nasdaq and Hong Kong Stock Exchange.
• Committed to gender diversity and promotion of women in biotech, achieving gender pay equity.
• Environmental protection, social responsibility, and corporate governance strategy ('Trust for Life') integrated within the business.

Equal Opportunity

• 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.