Director, Clinical Pharmacology & Pharmacometrics

Company: AstraZeneca
Location: Montgomery Village
Posted on: February 17, 2026

Job Description:

TheDirector, Clinical Pharmacology &Pharmacometricswill set and execute the quantitative strategy across a diverse portfolio ofcell therapyproducts, translating advanced cellular kinetics and exposure–response modeling intodose optimization, patient selection,programdecisionandstrategy.You willensurestate of the artmodel-informed drug development (MIDD)isimplemented to support AstraZenecas cell therapy pipeline, integrating cutting edgemodeling with novel cell therapy biomarkers, translational endpoints, andclinicaldata. Working crossfunctionally and with external partners, you will build mechanistic and empirical models,advisetrialdesignand 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. Responsibilities: Build MIDD across cell therapyportfolio. Lead quantitative strategies acrossallphases, including CK characterization, exposure–response for efficacy and safety. Develop mechanistic andempiricalmodels, enabling clear decisionmaking, optimized dosing regimen, and streamlined development paths. Partner withproject team(clinical, translational medicine,CMC, etc.)to linkpatient characteristics andproduct attributes to clinical outcomes. Ensure modeling strategies align with regulatory expectations (e.g., FDA MIDD), supporting submissions, dosejustifications,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’sleadershipthrough speaking, publications, and consortium participation in cell therapy modeling. Education and Experience: PhD inpharmacometrics,pharmacokinetics,biostatistics,orrelateddiscipline. At least6 Years of industry drug development experience inpharmacometricssupportingdecision-making, dose selection, studydesignand regulatory interactions. Hands on experience and advancedproficiencyin usingpharmacometricssoftware includingNONMEM, 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,standardsand issues specific to pharmacometrics. Ability to plan and implementpharmacometricsapproaches (PopPK, PKPD, exposure–response, QSP, Bayesian/adaptive methods) that drivedoseselectionand enable go/no-godecisions. Integration of quantitative pharmacology with innovative biomarkers, AI enabledanalyses, novel endpoints, and adaptive trial design. Experience in application ofAIandML in pharmacometricshighlydesirable. Pharmacometrics experienceacross cell therapyplatforms(CAR T, TCR,autologous,allogeneic, in vivo, etc.)anddisease areas(hematology, oncology, immunology, etc.)desirable. The annual base pay for this position ranges from $169K to $254K. 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. Date Posted 14-Feb-2026 Closing Date 01-Mar-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Keywords: AstraZeneca, Frederick , Director, Clinical Pharmacology & Pharmacometrics, Science, Research & Development , Montgomery Village, Maryland