Job Description
Key Responsibilities
Utilizes a variety of analytic software to integrate PK drug concentration-time measures, pharmacodynamic responses, and clinical safety and efficacy information for PK/PD and Modeling and Simulation (M&S) analyses. Represents Clinical Pharmacology line function and works on a multi-functional team (clinical, regulatory, biometrics, etc.) to support late-stage discovery programs from preclinical development to IND filing and throughout clinical development. Independently analyzes, interprets and reports clinical PK data as a member of several multidisciplinary development program teams. Works with clinical teams to design PK components in various study designs, such as first-in-human and drug-drug interaction studies. Familiarity with quantitative approaches in drug development with working knowledge of relevant modeling software (e.g. SimCyp, NONMEM) Writes and reviews relevant s...