Director, Clinical Science - Zai Lab (US) LLC

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.

Reporting to the Oncology Executive Medical Director, the Director Clinical Science drives the scientific rigor and integrity of our clinical research. This role involves development of clinical protocols to ensure clinical trials meet regulatory standards and include unbiased and well-controlled clinical design. The Director will collaborate closely with cross-functional teams, including clinical operations, translational medicine, regulatory affairs, and medical affairs, to ensure the seamless execution of clinical trials that meet the highest standards of quality and compliance. The position will be based in our office in South San Francisco, CA.

• Develop and implement standards for clinical protocols, including data monitoring and preparation of clinical data to ensure consistency and quality.
• Strategically collaborate with colleagues across various departments to gather input and refine clinical protocols.
• Work closely with study physicians to analyze and interpret clinical trial data, ensuring accuracy and integrity in data reporting.
• Lead the creation, review, and submission of key clinical documents such as protocols, informed consent forms, clinical study reports, and regulatory submissions.
• Collaborate with regulatory affairs to support regulatory strategy development, submissions and interactions with health authorities.
• Work closely with other departments within R&D to align clinical science activities with broader company objectives, including business development diligence.
• Build and manage a team of clinical science professionals, fostering a culture of excellence and continuous learning.
• Engage with key stakeholders, including clinical investigators, key opinion leaders, patient advocacy groups, and academic institutions, to advance clinical research initiatives.
• Ensure compliance with all applicable regulatory standards and ethical guidelines in the conduct of clinical research.
• Work across several time zones and travel up to 30%.

REQUIRED

• MS in a relevant scientific discipline with 8 years of experience in clinical research within the biopharmaceutical industry; or equivalent combination of higher education, training and experience.

PREFERRED

• PharmD or PhD preferred
• Experience with global clinical trials and experience in all phases of drug development
• Proven track record of leading clinical science teams and successful execution of clinical trials and outcomes.
• Outstanding knowledge of industry issues and competitive landscape in drug development.
• Strong leadership skills and the ability to manage and develop high-performing teams; strong collaboration and teamwork in cross-functional setting; comfortable with a hands-on leadership position.
• Excellent communication and collaboration skills to effectively interact with internal and external stakeholders.

The pay range for this position at commencement of employment is expected to be between $221K and $258K/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.

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.