Job Description - Senior Scientist, Clinical Pharmacology (240055) Overview
The Senior Scientist, Clinical Pharmacology position will support a rapidly expanding clinical portfolio of promising RNAi therapeutics. The candidate in this position should be well versed in PK and PD with strong ability to critically evaluate and interpret data, conduct noncompartmental analysis, and PKPD modeling. In this role, the candidate is expected to have a strong critical thinking ability with good oral and written communication skills.
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. #J-18808-Ljbffr