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Senior Scientist, Translational Medicine
• Ph.D. or PharmD with emphasis in pharmacokinetics, pharmacology or related discipline.
• 3-4+ years of experience preferred.
• Background in pharmacokinetics, drug metabolism, and bioanalytical chemistry desired, along with experience designing, executing and/or managing outsourced nonclinical studies and clinical pharmacology.
• Experience in preparation of manuscripts, study reports and sections of regulatory submission documents (eg: INDs, CTDs) required.
• A strong understanding of pharmacokinetic theory and statistical approaches utilizing the latest computational approaches and tools (eg: WinNon Lin, SAS) is a plus in this role.
• Strong understanding of in vitro metabolism and transporter experimental design and execution and relevant FDA guidances
• Demonstrated experience with non-compartmental analysis required (WinNonLin); compartmental modeling experience with NONMEM, population pharmacokinetic analyses, pharmacometric/PK-PD modeling a plus
• Familiarity with statistical approaches and programs for data analysis
• Scientific writing and presentation skills are essential; first-author peer reviewed publications in a relevant field required
• Current knowledge of FDA regulatory guidances related to nonclinical and clinical pharmacology
• Understanding of, and compliance with, regulatory, protocol, standard operating procedures, and Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) as appropriate
• Excellent interpersonal, leadership, communication and time-management skills are essential
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