Director of Clinical Pharmacology

VirtualVocations
Littleton, Colorado, United States
Full-time

A company is looking for a Director / Sr. Director, Clinical Pharmacology.Key ResponsibilitiesDesign and implement Clinical Pharmacology plans and manage the study process from protocol development to final reportingEvaluate clinical PK / PD data and support quantitative clinical pharmacology strategy for development teamsPrepare regulatory submissions and represent Clinical Pharmacology in meetings with regulatory agenciesRequired Qualifications, Training, and EducationPhD, MD, or PharmD with expertise in pharmacokinetics, pharmacology, or pharmaceutical scienceMinimum of 10-12 years of direct industry experience in clinical stage drug developmentExpertise in modeling and simulation activities, including population PK / PD modelingExperience in developing clinical pharmacology plans and preparing regulatory submissionsKnowledge of clinical drug development and FDA / ICH guidance documents

3 days ago
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