An accomplished senior pharmaceutical industry executive with diverse experience especially in clinical pharmacology/translational medicine, drug metabolism and also working closely with the primary fields of drug development. Built state of the art and very successful clinical pharmacology department, comprised of bioanalytical sciences, human ADME and clinical pharmacokinetics (plus translational model based drug development) at Sepracor from the ground up. An innovative leader in globalization of clinical pharmacology/translational medicine function and clinical research post acquisition of Sepracor. Hands-on scientist and leader of both classic PK and population PKPD analyses. Also experienced in pre-clinical research. Proven track record of success working with FDA that includes IND’s, milestone briefing books (including modeling/simulation) and numerous NDA’s and sNDA’s. Successfully managed multi-million dollar budget and outsourcing contracts.
Listed skills include Drug Development, Pharmaceutical Industry, Clinical Development, Clinical Trials, and 31 others.