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About the Role

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.

Responsibilities

• 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.

Requirements

• 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.
• 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.

Skills

• Clinical Pharmacology
• Modeling and Simulation
• Bioanalytical activities
• PK/PD
• Exposure-response evaluation
• PBPK
• Quantitative methods
• GLP
• GCP
• ICH
• Global regulatory guidelines
• Communication skills
• Influencing skills
• Cross-functional collaboration
• Business development evaluations
• Due diligence
• External collaborations

Location

• South San Francisco, CA

Work Type

• Full-time

Experience Level

• 12 years relevant experience in drug development
• Demonstrated leadership experience

Education Level

• PhD in Clinical Pharmacology, Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or a related field

Salary/Compensations

• $283k and $411K/year

Benefits

• Sign-on bonus
• Restricted stock units
• Discretionary awards
• Full range of medical benefits
• Financial benefits
• 401(k) eligibility
• Various paid time off benefits
• Vacation
• Sick time
• Parental leave

About the Company

• 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.
• 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.

Equal Opportunity

• 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.