Head of Clinical Pharmacology

Job Description

Job Description

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

Primary Function:

Zai Lab is seeking an experienced Clinical Pharmacology leader to lead the Clinical Pharmacology function and serve as a key member of the Development Leadership Team. This role is responsible for clinical pharmacology strategy, model-informed drug development, and regulatory support across Zai Lab’s portfolio, supporting global development of small molecules, biologics, and other innovative therapeutics.

This role is based in our South San Francisco, CA office.

Major Responsibilities and Duties:

• Provide strategic leadership for the Clinical Pharmacology function, including clinical pharmacology, modeling and simulation, and bioanalytical activities across Zai Lab’s portfolio.
• Develop and implement clinical pharmacology strategies to support global development and registration of small molecules, biologics, and other innovative therapeutics.
• Serve as the clinical pharmacology lead for development programs and contribute to key development, regulatory, and portfolio decisions.
• Lead clinical pharmacology assessments and quantitative analyses, including PK/PD, exposure-response evaluation, modeling and simulation, and human dose projection to support development and regulatory strategies.
• Partner closely with Clinical Development, Translational Sciences, DMPK, Regulatory Affairs, Biometrics, and other cross-functional teams to ensure effective integration of clinical pharmacology into development plans.
• Oversee the quality, execution, interpretation, and reporting of clinical pharmacology activities conducted internally and through CROs, alliance partners, and external collaborators.
• Lead the preparation of clinical pharmacology components of regulatory submissions and regulatory interactions, including INDs, CTAs, protocols, IBs, briefing documents, and responses to health authority inquiries.
• Evaluate and implement appropriate clinical pharmacology, bioanalytical, and quantitative science technologies and capabilities to support portfolio needs.
• Build and develop a high-performing Clinical Pharmacology organization through talent development, succession planning, and capability building.
• Provide clinical pharmacology leadership for business development evaluations, due diligence activities, and external collaborations.

Qualifications

Required:

• PhD in Clinical Pharmacology, Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or a related field, with 12 years’ relevant experience in drug development, including industry, regulatory, or other related settings; or equivalent combination of higher education, training and experience.

Preferred:

• Demonstrated leadership in clinical pharmacology and drug development.
• Demonstrated knowledge of clinical pharmacology, non-clinical packages, and regulatory requirements supporting global drug development, including first-in-human studies, dose justification, registration programs, and post-approval commitments. Strong knowledge of GLP, GCP, ICH, and relevant global regulatory guidelines is required.
• Demonstrated experience applying model-informed drug development approaches, including population PK, exposure-response analyses, PBPK, and other quantitative methods to support development and regulatory decision-making.
• Experience leading clinical pharmacology contributions to regulatory submissions and interactions with global health authorities, including FDA, EMA, CDE, and other regulatory agencies.
• Experience managing external partners, CROs, and vendors supporting clinical pharmacology, bioanalytical, and modeling activities. Strong communication and influencing skills with the ability to work effectively across cross-functional teams and senior leadership.
• Proven leadership experience in building and developing high-performing teams, driving organizational capability, and leading cross-functional collaboration in a matrix environment.
• Experience supporting business development evaluations, due diligence activities, and external collaborations is preferred.
• Experience in biotech and cross-regional collaboration with Asia/China.
• 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 $283k and $411K/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.