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About the Role

Serve as the Clinical Pharmacology Lead for assigned development programs, providing scientific leadership in model-informed drug development (MIDD) from early development through registration and lifecycle management. Develop and implement integrated clinical pharmacology and MIDD strategies, including PK, PK/PD, population PK, exposure-response, PBPK, and translational modeling to support key development and regulatory decisions.

Responsibilities

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.

Requirements

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.
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.

Skills

Clinical Pharmacology
Model-Informed Drug Development (MIDD)
PK
PK/PD
Population PK
Exposure-Response
PBPK
Translational Modeling
Quantitative Approaches
Modeling & Simulation (M&S)
NONMEM
Monolix
Simcyp
GastroPlus
R

Location

South San Francisco, CA

Work Type

Full-time

Experience Level

Associate Director
10 years of experience
7 years of experience (PhD)

Education Level

Salary/Compensations

$198K - $257K/year

Benefits

Sign-on bonus
Restricted stock units
Discretionary awards
Full range of medical benefits
Financial benefits
401(k) eligibility
Paid time off (vacation, sick time, parental leave)

About the Company

Zai Lab Limited is an innovative, research-based, commercial-stage biopharmaceutical company focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world.
Founded in 2014, Zai Lab has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage pipeline of innovative drug candidates.
Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to access the Chinese market and find a long-term strategic partner for global clinical development.
The company's unique business model builds on in-licensed assets and innovative partnerships to expand internal discovery and development capabilities, creating a portfolio of potential best-in-class and/or first-in-class therapies.
Zai Lab 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, becoming dual-primary listed on both exchanges in 2022.
As of January 2022, the Company has a global team of approximately 2000 employees.

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.
Zai Lab is 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.