The Pharmacometrics Group applies a range of model informed drug development (MIDD) approaches to support early and late-stage development of small and large molecules. We are seeking a skilled and qualified industrial scientist who has experience in planning and executing MIDD approaches to join us as a Principal Scientist. In this role, you will be responsible for the recommendation and implementation of pharmacometrics methodologies, contributes to internal and external clinical pharmacokinetic (PK) and pharmacodynamics (PD) modeling and simulation activities. Conducts PK/PD modelling and simulation in support of early stage programs or internal decision-making of late-stage programs. Will present modelling and simulation analyses to internal project teams and may present to external colleagues or regulatory agencies. You will work with experienced pharmacometricians, Preclinical Pharmacokinetics, Drug Metabolism, Toxicology, and Clinical Pharmacology colleagues to provide inputs to overall product development plans and to address research and development objectives and issues

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Your Contributions (include, but are not limited to):

• Represent the Pharmacometrics Group in multi-function matrix teams and serve as a subject matter expert


• Lead the planning, execution, and timely delivery of MIDD and Pharmacometrics strategies and documents to support dose selection, clinical trial design and regulatory submissions on assigned programs

• Oversees the design, conduct, and reporting of modeling and simulation analyses conducted by external Contract Research Organizations (CROs) in support of regulatory submissions

• Independently conducts PK/PD analyses of data from Phase 1/2 studies and application of quantitative decision-making to assist in the characterization of population PK, dose- and exposure-response relationships to optimize subsequent clinical development


• Communicate and interpret modeling results to project teams. Accountable for ensuring appropriate design and implementation of pharmacometrics plans


• Collaborate with other colleagues to review and validate M&S outputs such as datasets and modeling programs


• Prepare posters, publications, presentations for internal and external conferences


• Performs other duties as assigned

Requirements: