Director, Clinical Pharmacology & Pharmacometrics

AstraZeneca • Gaithersburg, MD

15d

About The Position

The Director, Clinical Pharmacology & Pharmacometrics will set and execute the quantitative strategy across a diverse portfolio of cell therapy products, translating advanced cellular kinetics and exposure–response modeling into dose optimization, patient selection, program decision and strategy. You will ensure state of the art model-informed drug development (MIDD) is implemented to support AstraZeneca's cell therapy pipeline, integrating cutting edge modeling with novel cell therapy biomarkers, translational endpoints, and clinical data. Working cross functionally and with external partners, you will build mechanistic and empirical models, advise trial design and dose selection, and grow capabilities through mentoring and knowledge sharing. You may be based in Gaithersburg, MD or Santa Monica, CA and will report to Senior Director, Clinical Pharmacology.

Requirements

• PhD in pharmacometrics, pharmacokinetics, biostatistics, or related discipline.
• At least 6 Years of industry drug development experience in pharmacometrics supporting decision-making, dose selection, study design and regulatory interactions.
• Hands on experience and advanced proficiency in using pharmacometrics software including NONMEM, Phoenix/NLME, R, SAS, Python, etc.
• Be able to work in a matrix team environment and influence the team with a data-driven approach.
• Knowledge of global regulatory, compliance, processes, standards and issues specific to pharmacometrics.
• Ability to plan and implement pharmacometrics approaches (PopPK, PKPD, exposure–response, QSP, Bayesian/adaptive methods) that drive dose selection and enable go/no-go decisions.
• Integration of quantitative pharmacology with innovative biomarkers, AI enabled analyses, novel endpoints, and adaptive trial design.

Nice To Haves

• Experience in application of AI and ML in pharmacometrics highly desirable.
• Pharmacometrics experience across cell therapy platforms (CAR T, TCR, autologous, allogeneic, in vivo, etc.) and disease areas (hematology, oncology, immunology, etc.) desirable.

Responsibilities

• Build MIDD across cell therapy portfolio.
• Lead quantitative strategies across all phases, including CK characterization, exposure–response for efficacy and safety.
• Develop mechanistic and empirical models, enabling clear decision making, optimized dosing regimen, and streamlined development paths.
• Partner with project team (clinical, translational medicine, CMC, etc.) to link patient characteristics and product attributes to clinical outcomes.
• Ensure modeling strategies align with regulatory expectations (e.g., FDA MIDD), supporting submissions, dose justifications, and scientific advice.
• Provide peer review and mentoring across programs to strengthen scientific rigor and consistency in pharmacometrics practice.
• Monitor and adopt emerging methodologies (QSP for cell therapies, AI/ML for biomarker integration, MIDD regulatory pilots, etc.).
• Advance AstraZeneca’s leadership through speaking, publications, and consortium participation in cell therapy modeling.

Benefits

• Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
• Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree