US: Senior Scientist in Biotech

Date: 22-May-2012
To see other BioTech job opportunities, please visit http://biotech.fyicenter.com/

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

To apply for this position, please visit this Website.

Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/