• US: Sr Scientist Translational Medicine

    From sqafyi@yahoo.com@21:1/5 to All on Wed Sep 23 11:31:23 2015
    US: Sr Scientist Translational Medicine
    To apply for this position, please visit this Website. http://biotech.fyicenter.com/jobs/99886726_Sr_Scientist_Translational_Medicine.html
    Date: 23-Sep-2015
    To see other BioTech job opportunities, please visit http://biotech.fyicenter.com/

    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.

    Thank you,
    BioTech FYI Center

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