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Associate Director, Pharmacometrics

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Job Description - Associate Director, Pharmacometrics

Develop and execute population PK, PK/PD, exposure response, disease progression models, dose selection for phase 3 strategies/plans and corresponding models for the pharmacometric function from early clinical studies through Phase 3 study As the M&S project lead on one or more cross-functional development teams, develop and execute M&S strategies and plans fully integrated with the overall preclinical and clinical plans; By using state of the art M&S methodologies strongly contribute to decision making at critical milestones based on quantitative principles in close collaboration with DMPK, Stat, Clin Pharm, Medical Sciences, Research, and other quantitative disciplines; Perform population PK, PK/PD analyses, clinical trial simulations and other model-based analyses when appropriate; Strengthen and build internal M&S capability on a continuous basis by attending trainings, evaluating and introducing new M&S tools and computing platform as appropriate; Prepare population PK/PD reports and corresponding regulatory submission documents. A PhD, degree or equivalent in quantitative sciences, background in engineering, or clinical pharmacology is desired. 5+ years pharmaceutical industrial and/or postdoctoral experiences in the related disciplines of clinical pharmacology, and PKPD Excellent hands-on knowledge in R and/or SAS, NONMEM; Well versed at plotting complex data to identify trends important for drug development; Track record of publishing M&S work; Excellent written and verbal communication skills;
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