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 landscape.
• Scientific Inquiry and Knowledge Maintenance: Proactively drive scientific questions and ideas that support clinical hypothesis generation and life cycle management opportunities, generating value for the asset. Maintain up-to-date knowledge of relevant scientific literature and clearly communicate key impactful information.
• Business Development: Participate in business development activities to support the company's growth and expansion.

Qualifications

_ REQUIRED_

• MD with 12 years clinical oncology research experience with track record of development strategy, protocol and study report writing, successful execution of strategy in the US and global regions, especially in Asia and EU.
• Work across several time zones and travel up to 30%.

_ PREFERRED_

• Proven experience in study design, protocol development, monitoring, and implementing clinical trials, with demonstrated strategic influence on clinical studies/programs.
• In-depth understanding of regulatory requirements and guidelines for oncology drug development.
• Excellent communication and interpersonal skills, with the ability to engage effectively with internal and external stakeholders.
• Ability to form and maintain excellent relationships outside the company, interact with regulatory agencies, and demonstrate high credibility in scientific, clinical, and drug development competency.
• Knowledge of emerging trends and technologies in oncology research.
• Exceptional analytical and problem-solving skills.
• Strong leadership skills with the ability to manage and develop high-performing teams.
• Outstanding collaboration and teamwork in a cross-functional setting; comfortable with a hands-on leadership position.
• Must have the highest personal values and ethical standards.

Additional Information

The pay range for this position at commencement of employment is expected to be between $376K and $439K/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.

At Zai, we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 58% of our employees are women and 54% of our management positions are held by women. We are committed to the health of patients and our planet. That’s why our environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life” is integrated within our business.

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.

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.

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