What are the responsibilities and job description for the Clinical Pharmacologist position at Talent Groups?
- Education: Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field with 3 years or 4 years of experience in pharmaceutical industry. Demonstrated experience in serving as clinical pharmacology lead on development programs.
- PK Experience: The incumbent should have a strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools.
- Knowledge: Sound working knowledge of the cross-function interfaces that are important for efficient drug development, and a detailed understanding of non-clinical and clinical DMPK processes.
- Programming experience (Phoenix) is must; other programming experience (e.g., , Monolix, R, WinNonlin, SAS, Splus) is desirable.
- Regulatory: Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents is required.
- Writing: Experience in non-compartment and model-based PK and PK/PD analyses and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory submission documents (e.g.: INDs, NDAs, CTDs) is required.
Salary : $90 - $95