Executive Medical Director

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 discovering, developing and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience , and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide.

Zai Lab has its U.S. headquarters in Cambridge, Mass. and R&D functions in the San Francisco Bay Area and San Diego, where its U.S.-based clinical development and clinical operations teams reside. Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical companies, generating a broad late-stage pipeline of innovative drug candidates. 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 seven approved products 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. 
 

Job Description

The Executive Medical Director, Oncology, will lead the strategic direction and execution of early-stage oncology programs. Reporting to the SVP, Global Clinical Development, Oncology, this role involves strategizing and overseeing clinical development, ensuring regulatory compliance, and driving innovative oncology research. Leading a team of physicians and/or clinical scientists, the Executive Medical Director will drive strategy, lead the design, execution, monitoring, and data interpretation of multiple studies, ensuring clinical data meets global regulatory standards. Additionally, he/she will lead the cross-functional Clinical Program Team, set team goals, balance cost/time/quality, develop risk mitigation strategies, troubleshoot issues, represent the program at health authority interactions, review publications, and drive process improvements, among other business needs such as diligence for business development. This role is based in our South San Francisco, CA office.

• Leadership and Expertise: Provide leadership and clinical expertise in global oncology clinical research and drug development throughout the lifecycle.
• Clinical Development: Responsible for the clinical development plan including appropriate clinical trial designs to support and inform the target product profile.  
• Study Design and Execution: Design, deliver, and interpret clinical studies, ensuring ethical and scientific integrity, meeting regulatory requirements, and in 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. 
• Team Vision and Management: Set team vision and goals aligned with oncology leadership and product strategy. Lead and mentor a team of medical directors, clinical scientists, and other cross-functional professionals.
• 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.
• Strategic Knowledge: Provide strategic clinical and scientific knowledge into development decision points and target labeling, integrating insights from literature, advisory boards, and competitive landscape.
• Scientific Inquiry: Proactively drive scientific questions and ideas that support clinical hypothesis generation and life cycle management opportunities, generating value for the asset.
• Knowledge Maintenance: Maintain up-to-date knowledge of relevant scientific literature and clearly communicate key impactful information.
• Mentorship: Serve as a source of expert medical and scientific knowledge for the clinical team, analyzing and interpreting medical and scientific data, and providing hands-on coaching and mentoring.
• Work across several time zones and travel up to 30%.
   

Qualifications

REQUIRED:

• MD with eight (8) 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.

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 $335k and $390k /year. Base pay offered may vary depending on multiple individualized factors, including location, job-related knowledge, skills, education and experience. The total compensation package for this position may also include other elements, including corporate bonus and equity awards.  In addition Zai Lab offers a robust benefits package which includes comprehensive health insurance, 401(k) with company match, family advocacy programs, and various paid time off benefits, such as vacation, sick time, and parental leave. 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 and benefits 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, military or veteran status,  medical condition, disability, ancestry, or  genetic information.

Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context.  Privacy Notice available upon request.