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Associate Director

$160.8k - $201k

Sarepta Therapeutics Inc

About the Role The Associate Director, Quantitative Clinical Pharmacology is responsible for providing translational, clinical pharmacology, and pharmacometrics deliverables for development assets from pre‑IND to Phase III. The incumbent will apply quantitative modeling methodologies—including population PK, PK/PD, and disease progression modeling—to integrate, analyze, and interpret diverse data sources such as pharmacokinetics, pharmacodynamics (including biomarker & imaging), and electronic health records. This role will drive and support pharmacology and pharmacometrics activities for dose selection and to characterize interactions between drugs, patients, and biological systems, identifying key predictors. Responsibilities Lead the development and execution of quantitative pharmacology strategies across all stages of development through product registration. Provide expert clinical pharmacology support in clinical and translational development strategies, protocol preparation, study execution, data review/analysis, and study reports. Conduct advanced quantitative pharmacology and pharmacometrics analyses—including population PK, PK/PD modeling and simulation, meta‑analysis, and disease modeling—to deliver high‑value PK/PD support for critical clinical decisions and dose selection. Serve as the functional lead for global regulatory strategies and regulatory documents. Maintain leading‑edge knowledge in the discipline, publish manuscripts, and present at scientific conferences and forums. Qualifications PhD in Pharmaceutical Sciences, mathematics/engineering, or a related field with a minimum of five years’ experience in clinical pharmacology or pharmacometrics. Strong understanding of clinical pharmacology principles and hands‑on experience with PK/PD modeling and analysis. Experience in regulatory interactions and in developing advanced pharmacometrics, PK/PD, and PBPK models to aid R&D decision‑making. Proficiency with pharmacometrics analysis software, such as NONMEM, R, or Phoenix. Excellent communication, multitasking, and collaboration skills. Strong analytical skills and strategic thinking. Employment Details Hybrid position: expected to work on site at one of Sarepta’s facilities in the United States and/or attend company‑sponsored in‑person events from time to time. Targeted salary range: $160,800 – $201,000 per year. Must be authorized to work in the U.S. Equal Opportunity & EEO Statement Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e‑Verify. #J-18808-Ljbffr

Vacancy posted 3 days ago
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