- Identify critical DMPK needs and propose strategies to program teams ranging from exploratory research through development.
- Design and oversee DMPK studies (including in vitro metabolic stability, P450 inhibition and induction, in vivo pharmacokinetics / ADME studies in animal models, drug interaction studies).
- Review and summarize results, integrate ADME, PK, and PK/PD information to guide multi-disciplinary team efforts in lead optimization and to facilitate selection of development candidates.
- Deliver and communicate results to project teams, provide intellectual input, and contribute to decision making.
- Select, manage, and monitor CROs to meet project needs.
- Author nonclinical documents for Regulatory submission (study summaries, CTD tables, Annual Reports, Investigator Brochures, and integrated summaries) in collaboration with team representatives.
Experience, Education and Specialized Knowledge and Skills
- PhD in Pharmacokinetics, or related disciplines with 2+ years of relevant experience in the pharmaceutical industry; or MS with at least 6+ years of relevant experience; or BS with at least 8+ years of relevant experience.
- In-depth understanding of in vitro and in vivo ADME assays, methods, and models.
- Direct hands-on experience and general trouble shooting skills in in vitro and vivo DMPK studies, including PK and PK/PD analysis, quantitative and qualitative LC-MS analysis, and in vitro and in vivo biotransformation.