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US: Sr Scientist Translational Medicine

Date: 23-Sep-2015
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Sr Scientist/Staff Scientist, Translational Medicine

Minimum Education & Experience Requirements:

Ph.D. or PharmD with emphasis in pharmacokinetics required.

Senior Scientist level requires a Ph.D./PharmD and 5+ years of experience

Staff Scientist level requires a Ph.D./PharmD and 8+ years of experience

A background in drug metabolism is desired, with demonstrated experience designing, executing and/or managing outsourced clinical pharmacology , and nonclinical in vitro and in vivo studies.

Experience in noncompartmental pharmacokinetic analysis and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory submission documents (eg: INDs, CTDs) is required.

Demonstrated experience with non-compartmental analysis required (WinNonLin); compartmental modeling experience with NONMEM, population pharmacokinetic analyses, pharmacometric/PK-PD modeling.

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 guidance related to nonclinical and clinical pharmacology; direct interaction with FDA, including submission of IND and other regulatory documents (required for Staff Scientist level)

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; For the Staff Scientist level, demonstrated direct management of personnel, including but not limited to outsourced projects is required.

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