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.

Qualifications

• 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.