Clinical Pharmacometrician

Title:Clinical Pharmacometrician

Location: Gaithersburg, MD

Position Summary: 

TheClinical Pharmacometricianwill set and implement the quantitative strategy across a diverse portfolio ofcell therapyproducts, translating advanced cellular kinetics and exposure–response modeling intodose optimization, patient selection,programdecisionandstrategy.

You willensureinnovativemodel-informed drug development (MIDD)isimplemented to support AstraZeneca's cell therapy pipeline, integrating innovativemodeling with novel cell therapy biomarkers, translational endpoints, andclinicaldata. Working crossfunctionally and with external partners, you will build mechanistic and empirical models,advisetrial design and dose selection.

Responsibilities:

• Build MIDD across cell therapyportfolio.

• Partner with project teams(physicians, clinical pharmacologyscientistsand statisticians, etc.)to buildpopulation PK, PKPD,andexposure-responsemodelsto support design and interpretation of clinical studies, influence key decisions inresearch anddevelopment,and support regulatory submissions ofcell therapy products.

• Develop mechanistic andempiricalmodels, enabling clear decisionmaking, optimized dosing regimen, and streamlined development paths. 

• Ensure modeling strategies align with regulatory expectations (e.g., FDA MIDD), supporting submissions, dosejustifications,and scientific advice.

• 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:

• Minimum of aPhD inpharmacometrics,pharmacokinetics,biostatistics,orrelated field.

• Minimum of0 – 3Years of industry drug development experience inpharmacometricssupportingdecision-making, dose selection, studydesignand regulatory interactions.

• Hands on experience and advancedproficiencyin usingpharmacometricssoftware includingNONMEM, Phoenix/NLME, R, SAS, Python,MATLAB,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.

Preferred Experience: 

• Experience in application ofAIandML in pharmacometricshighlydesirable.

• Pharmacometrics experienceacross cell therapyplatforms(CAR T, TCR,autologous,allogeneic, in vivo, etc.)anddisease areas(hematology, oncology, immunology, etc.)highlydesirable.

The annual base pay (or hourly rate of compensation) for this position ranges from $124,713.60 - $187,070.40.USD. 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.