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US: Senior Scientist in Biotech

Date: 22-May-2012
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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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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/