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Zai Lab (US) LLC

Develops, licenses, markets biopharmaceutical therapies

Senior Medical Director - Oncology Clinical Development

Biology & BiotechConfirmed live in the last 24 hours
Full-timeCambridge, MA, USA

About the Job

Requirements

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

Responsibilities

  • Lead late-stage clinical development programs in oncology, including pivotal Phase III trials and registration studies.
  • Contribute to and execute clinical strategy, serve as Medical Monitor, support regulatory submissions and commercialization efforts, and collaborate with and lead cross-functional teams.
  • Provide medical leadership for the design and execution of late-stage clinical trials, including pivotal and confirmatory studies, collaborating with clinical operations to ensure alignment 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 medical and scientific leadership to clinical development strategies, regulatory submissions, and lifecycle planning.
  • Work with regulatory affairs, clinical operations, pharmacovigilance, biostatistics, medical affairs, and commercial teams to align clinical and business objectives.
  • Represent the company 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 decisions; collaborate to translate findings into actionable insights for clinical strategy, regulatory submissions, and program advancement.
  • Develop strategies for label expansion, post-marketing commitments, and long-term product differentiation.
  • Lead preparation of regulatory documents, participate in global health authority interactions, and contribute to risk management planning and mitigation throughout the development lifecycle.
  • Provide clinical expertise for licensing opportunities, partnerships, and due diligence activities.
  • Build stakeholder relationships, challenge ideas constructively, and drive evidence-based decision-making.
  • Maintain current knowledge of oncology trends, the competitive landscape, and regulatory changes to inform clinical strategy.
  • Work across several time zones and travel up to 30%.

Desired Qualifications

  • A proven track record as a Medical Monitor for pivotal trials and successful regulatory submissions.
  • A deep understanding of oncology drug development, clinical endpoints, and regulatory pathways.
  • The ability to lead cross-functional teams and manage complex clinical programs.
  • Clinical practice or investigator experience.

About the Company

Zai Lab (US) LLC

Develops, licenses, markets biopharmaceutical therapies

Zai Lab focuses on developing and commercializing therapies for cancer, infectious diseases, and autoimmune disorders, with a primary emphasis on China and the Asia-Pacific region. The company advances its products through R&D, clinical trials, and commercialization, and it manufactures small molecules and biologics in Suzhou to international quality standards. It distinguishes itself by collaborating with global partners to license and develop treatments, leveraging an integrated model that spans discovery, development, and market access in its target regions. Its goal is to bring effective, modern therapies to patients with unmet medical needs in its core markets, supported by product sales, licensing agreements, and strategic partnerships.

Company size
501-1,000
Company stage
IPO
Headquarters
Pudong, China
Founded
2014

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