Vice President, Clinical Development, Oncology

Company Description

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide.

Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical  companies, generating a broad and late-stage pipeline of innovative drug candidates. Based on our proven  track record of  success, Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to not only access the Chinese market but also find a long-term strategic partner for global clinical development.  Our unique business model builds on our in-licensed assets and innovative partnerships to expand our internal discovery and development capabilities and has created a portfolio of potential best-in-class and/or first-in-class therapies. Zai currently has four products on the market in China

Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed secondary listing on Hong Kong Stock Exchange in September 2020. In 2022, Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges. Since its inception, Zai Lab has expanded significantly with several offices across China. In 2021, Zai Lab established its U.S. Headquarters in Cambridge, Massachusetts.  As of January 2022, the Company has a global team of approximately 2000 employees.

Job Description

The Vice President, Clinical Development, Oncology, will primarily lead the cross-functional Zai Product Team, setting team goals, balancing cost, time, and quality, developing risk mitigation strategies, and troubleshooting issues. Reporting to the SVP, Global Clinical Development, Oncology, this pivotal role involves strategizing clinical development, ensuring regulatory compliance, and driving innovative oncology development strategy. Leading a team of physicians, the Vice President will formulate strategy, design, execute, monitor, and interpret multiple studies, ensuring clinical data meets global regulatory standards. This role will also represent the program at health authority interactions, create publications, and drive process improvements, among other business needs such as diligence for business development. This role is based in the South San Francisco, CA office.

• Leadership and Expertise: Provide strategic leadership and clinical expertise in global oncology clinical research and drug development throughout the entire lifecycle. Establish team vision and goals that align with oncology leadership and product strategy. Lead and mentor a team of medical directors and cross-functional professionals to achieve these objectives.
• Clinical Development and Study Design: Responsible for the clinical development plan including appropriate clinical trial designs to support and inform the target product profile. Design, deliver, and interpret clinical studies, ensuring ethical and scientific integrity, meeting regulatory requirements, and compliance with international standards and company policies such as GCP and ICH guidelines
• Regulatory Compliance: Understand and support regulatory compliance in all relevant jurisdictions, including, but not limited, to US, EU, UK, and China.
• Operational Management: Oversee the operational aspects of clinical trials, including budget management, resource allocation, and timeline adherence.
• Cross-Functional Collaboration: Lead and support colleagues necessary to drive the development program including, but not limited to, discovery and preclinical research (DMPK, toxicology, etc), clinical pharmacology, clinical operations, regulatory affairs, translational medicine, manufacturing, pharmacovigilance, and clinical quality to ensure successful execution of the clinical development plan.
• Stakeholder Engagement: Develop and maintain excellent relationships with external investigators and key opinion leaders and drive meaningful engagement and information exchange. Represent the company and deliver highest quality clinical information to regulatory authorities, ethics committees, and investigators/sites, providing clarifications and solving medical issues.
• Innovation and Research: Drive innovation in oncology research, integrating the latest scientific advancements into the company's programs. Provide strategic clinical and scientific knowledge into development decision points and target labeling, integrating insights from literature, advisory boards, and competitive lan