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.