Job Description: The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), Division of Scientific Support (DSS) is seeking qualified applicants for Clinical Pharmacologist positions. DSS provides expertise, leadership, and coordination to all CVM offices regarding biostatistics, clinical pharmacology, and environmental evaluations for reviews and research. Through our independent and collaborative reviews and evaluations, we support the Center’s scientific and regulatory goals to approve safe and effective animal drugs. This position will be filled through FDA’s Staff Fellowship program. The appointment is up to 2 years with opportunity for renewal This position is located within the Clinical Pharmacology Team of the Division of Scientific Support, in the Office of New Animal Drug Evaluation (ONADE). The team functions as subject matter experts in the disciplines of pharmacokinetics and biopharmaceutics. Using data submitted from scientific investigations, technical reports, opinion statements, and related information, team members evaluate drug dose-exposure relationships, absolute bioavailability and comparative bioavailability of new chemical entities intended for use in companion and food-producing animal species. In particular, reviewer responsibilities also include the evaluation of proposed pre-approval and post-approval formulation changes on the rate and extent of drug absorption by examining comparative drug concentration- time profiles in the blood or other biological fluid and comparative in vitro dissolution data. Upon completing this analysis, recommendations are made for Agency action regarding New Animal Drug Applications and Investigational New Animal Drug submissions. Job Details: Company: FDA Vacancy Type: Full Time Job Location: Hagerstown, MD, US Application Deadline: N/A Apply Here getyourvacancy.com
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