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 exposureresponse modeling intodose optimization patient selectionprogramdecisionandstrategy.

You willensureinnovativemodel-informed drug development (MIDD)isimplemented to support AstraZenecas cell therapy pipeline integratinginnovativemodeling with novel cell therapy biomarkers translational endpoints andclinicaldata. Working crossfunctionally and with external partners you will build mechanistic and empirical modelsadvisetrial design and dose selection.

Responsibilities:

• Build MIDD across cell therapyportfolio.

• Partner with project teams(physicians clinical pharmacologyscientistsand statisticians etc.)to buildpopulation PK PKPDandexposure-responsemodelsto support design and interpretation of clinical studies influence key decisions inresearch anddevelopmentand 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 dosejustificationsand scientific advice.

• Monitor and adopt emerging methodologies (QSP for cell therapies AI/ML for biomarker integration MIDD regulatory pilots etc.).

• Advance AstraZenecasleadershipthrough speaking publications and consortium participation in cell therapy modeling.

Education and Experience:

• Minimum of aPhD inpharmacometricspharmacokineticsbiostatisticsorrelatedfield.

• 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 PythonMATLABetc.

• Be able to work in a matrix team environment and influence the team with a data-driven approach.

• Knowledge of global regulatory compliance processesstandardsand issues specific to pharmacometrics.

• Ability to plan and implementpharmacometricsapproaches (PopPK PKPD exposureresponse QSP Bayesian/adaptive methods) that drivedoseselectionand enable go/nogodecisions.

• Integration of quantitative pharmacology with innovative biomarkersAIenabledanalyses novel endpoints and adaptive trial design.

Preferred Experience:

• Experience in application ofAIandML in pharmacometricshighlydesirable.

• Pharmacometrics experienceacross cell therapyplatforms(CAR T TCRautologousallogeneic in vivo etc.)anddisease areas(hematology oncology immunology etc.)highlydesirable.

The annual base pay (or hourly rate of compensation) for this position ranges from $124713.60 - $ positions offer eligibility for various incentivesan 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.