Biogen

Associate Scientific Director, Pharmacometrics

RemoteFull timeDirectorPosted 6 days ago
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About This RolePharmacometrics analyses and insight are critical in the development of drug candidates, determination of product viability, and maximization of commercial value at Biogen.  As the Associate Director, Pharmacometrics, you will provide pharmacometrics expertise for high-priority clinical development programs and support quantitative decision-making through advanced modeling and simulation.In this role, you will contribute to the pharmacometrics strategy across disease areas and serve as a key scientific resource to program teams and functional partners. You will report to the Head of Pharmacometrics and collaborate closely with cross functional teams to ensure pharmacometrics analyses are appropriately applied to program needs.What You’ll DoProvide pharmacometrics expertise to activities throughout the drug development lifecycle and effectively collaborate with cross functional teams  Execute advanced pharmacometrics analyses, with emphasis on PK/PD modeling and simulation and exposure-response analysis for high priority programsIdentify opportunities where modeling and simulation can advance the understanding of pharmacokinetics, pharmacodynamics, efficacy and safetyContribute to Model Informed Drug Development (MIDD) activities to support dose selection, regimen optimization and clinical trial designCommunicate the pharmacometrics analysis results to program teams to support data-driven decision-making processMentor and guide Clinical Pharmacology and Pharmacometrics colleagues on pharmacometrics analyses methodologiesServe as a lead author and key contributor for pharmacometrics sections of clinical and regulatory documentsPublish in scientific journals and present at internal and external scientific eventsWho You Are You are a quantitative scientist with strong experience applying population PK/PD analysis methodology to drug development questions. You are comfortable working on complex problems, contributing scientific insight to multidisciplinary teams and supporting program-level decision-making through rigorous quantitative analyses. #LI-TD1QualificationsRequired SkillsPhD in Pharmacology, Pharmacokinetics, Pharmaceutics or a related quantitative discipline.5+ years of relevant industry experience applying population PK/PD and other advanced quantitative methodologies to decision makingDeep and extensive experience with advanced population PK/PD methodologyStrong understanding of the clinical pharmacology principles and methodologies and their application in drug developmentSolid knowledge of the drug development process and regulatory expectations for pharmacometrics analysesAbility to interpret quantitative results and translate analyses into actionable program insightsHands-on experience with pharmacometrics software tools such as NONMEM, Monolix, and R.Experience with mechanistic or systems pharmacology models is a plus. Job Level: ManagementAdditional InformationThe base compensation ran...