Associate Director, Clinical Pharmacology & MIDD

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.

Qualifications :

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.

Additional Information :

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. Thats 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.

Remote Work :

No

Employment Type :

Full-time