- Department
- Healthcare
- Education
- PhD
Description
Summary of Key Responsibilities
- Represent Clinical Pharmacology and provide PKPD support and guidance to clinical stage project teams.
- Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data
- Conduct PK/PD analyses to guide development decisions on project teams
- Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA.
- Prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data
- Preparation of abstracts and manuscripts for publication
- Closely partner with Research, Bioanalytical, Clinical functions, Regulatory, Project Management, and other R&D functions.
- Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with some experience in pharmaceutical industry, or M.D or Pharm.D. with equivalent experience
- Working knowledge of pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology.
- Proficient in using Phoenix WinNonlin, R, NONMEM, or other pharmacokinetic, modeling and data visualizations software.
- Strong communication skills (verbal and written) and presentation skills are required. Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential.
Skills
Project ManagementR