Associate Director, Clinical Pharmacology & MIDD

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.

Primary Function:

The Associate Director, Clinical Pharmacology & MIDD will serve as the Clinical Pharmacology Lead for assigned development programs and provide scientific leadership in model-informed drug development (MIDD), from early development through registration and lifecycle management for both small and large molecules. The role will develop and implement integrated clinical pharmacology and MIDD strategies, including PK, PK/PD, population PK, exposure-response, PBPK, translational modeling, and other quantitative approaches to support key development and regulatory decisions.

Working closely with Clinical Development, Translational Sciences, Biometrics, Regulatory Affairs, DMPK, Bioanalysis, external partners, and vendors, the Associate Director will ensure that clinical pharmacology data, modeling outputs, and quantitative insights are effectively integrated into program strategy, dose selection, study design, and regulatory planning.

This role is based in South San Francisco, CA.

Major Responsibilities and Duties:

• Serve as the Clinical Pharmacology Lead for assigned programs and provide clinical pharmacology and MIDD strategy from early development through registration and lifecycle management for both small and large molecules.
• Integrate clinical pharmacology principles and MIDD approaches to de-risk and accelerate programs and inform critical go/no-go decisions, first-in-human planning, dose escalation, dose optimization, RP2D selection, study design, and development strategy.
• Develop and execute integrated Clinical Pharmacology and Modeling & Simulation (M&S) plans for assigned programs, with clear quantitative objectives linked to key development decisions.
• Lead the design, execution, analysis, and interpretation of clinical pharmacology studies (e.g., DDI, organ impairment, food effect, QTc, BA/BE, and special population assessments) and translational PK/PD modeling efforts, as appropriate.
• Lead the fit-for-purpose application of quantitative methodologies, including population PK, PK/PD, exposure-response, PBPK, translational modeling, model-based meta-analysis, and QSP, to address key drug development questions.
• Ensure the scientific rigor, quality, and regulatory compliance of all clinical pharmacology and MIDD analyses and deliverables, including critical evaluation of model assumptions, uncertainty, qualification, and interpretation.
• Represent Clinical Pharmacology and MIDD for assigned programs in cross-functional teams and interactions with global health authorities (e.g., FDA and EMA), in partnership with the Head of Clinical Pharmacology.
• Lead the authorship and critical review of clinical pharmacology and quantitative sections for key documents, including INDs, CTAs, IB updates, briefing packages, health authority responses, and NDAs/BLAs.
• Present and defend clinical pharmacology and MIDD strategies, modeling approaches, assumptions, and recommendations during internal governance reviews, health authority consultations, and submissions.
• Provide scientific mentorship and technical guidance to clinical pharmacologists and modelers and contribute to capability building within the function.
• Translate complex clinical pharmacology concepts and model-based insights into clear, actionable recommendations that influence senior leadership, project teams, and external partners.
• Provide Clinical Pharmacology and MIDD input to internal governance bodies (e.g., Development Review Committees), portfolio reviews, due diligence, business development activities, and external collaborations.

REQUIRED

• BS in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, Systems Pharmacology, Biomedical Engineering, or a related discipline with 10 years of experience in clinical pharmacology, pharmacometrics, MIDD, or related quantitative sciences supporting drug development; or equivalent combination of higher education, training and experience.

PREFERRED

• PhD with at least 7 years’ related experience.
• Demonstrated experience developing and executing integrated Clinical Pharmacology and MIDD strategies across multiple stages of drug development, including regulatory submissions and health authority interactions.
• Demonstrated ability to use clinical pharmacology and MIDD approaches to influence key development decisions, including dose selection, study design, phase transition, registration strategy, and health authority interactions.
• Demonstrated expertise in the fit-for-purpose application and critical evaluation of population PK, exposure response, PK/PD, PBPK, translational modeling, and other quantitative approaches. Ability to work effectively in a highly collaborative, multidisciplinary, and dynamic team setting.
• Excellent verbal and written communication skills.
• Proficiency in English is a must.
• Self-directed and highly motivated scientist with strong problem-solving skills and willingness to learn new tools and approaches.
• Experience leading or overseeing modeling activities conducted internally and through external partners, with the ability to critically assess model assumptions, uncertainty, and regulatory acceptability.
• Experience mentoring junior scientists and contributing to scientific capability development.
• Experience in cross-regional collaboration including Asia/China.
• Maintains the highest standards of integrity and ethics.
• Oncology drug development experience.
• Experience with biologics, ADCs, bispecific antibodies, T-cell engagers, cytokines, radiopharmaceuticals, or other complex therapeutic modalities.
• Experience applying MIDD approaches to first-in-human dose selection, RP2D determination, dose optimization, and registration strategies.
• Hands-on experience reviewing or directing quantitative analyses conducted using NONMEM, Monolix, Simcyp, GastroPlus, R, or equivalent platforms.

The pay range for this position at commencement of employment is expected to be between $198K and $257K/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 Lab, 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, 59% of our employees are women and 53% 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.