Associate Director, Clinical Pharmacology & MIDD

Zai Lab (US) LLC•South San Francisco, CA

67d•$198,000 - $257,000•Onsite

About The Position

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.

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.
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.
Maintains the highest standards of integrity and ethics.

Nice To Haves

PhD with at least 7 years’ related experience.
Experience in cross-regional collaboration including Asia/China.
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.

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.