FDA Pharmacometrics is looking for eligible scientists

Hello All Pharmacometrics, Office of Clinical Pharmacology, CDER, FDA is seeking a Pharmacometrics Reviewer. The incumbent serves as a pharmacometrics scientist and reviewer on a multi-disciplinary team of health care professionals who identifies the key issues of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs). The types of analyses conducted, the level of impact of the Pharmacometrics reviews and our Office vision can be appreciated from the following publications: 1. Bhattaram, A.V. et al. Impact of pharmacometrics on drug approvals and labeling decisions: survey of 42 new drug applications. AAPSJ 7, E503-E512 (2005). 2. Bhattaram, A.V. et al. Impact of pharmacometrics review on new drug approval and labeling decisions-a survey of 31 new drug applications submitted between 2005 and 2006. Clin Pharmacol Ther 81, 213-221 (2007). 3. Proceedings of the Clinical Pharmacology Sub-Committee Advisory Committee Meeting. Oct 26, 2006. ( http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4248B1-04-FDA-topi c-3-replacement.pdf). 4. Lesko LJ. Paving the critical path: how can clinical pharmacology help achieve the vision? Clin Pharmacol Ther. 2007 Feb; 81(2):170-7. Requirements include an earned Pharm.D., Ph.D., M.D. or other professional doctorate in a related discipline with focus on Pharmacometrics techniques and application to solve drug development related problems. A thorough knowledge of fundamental pharmacokinetics and pharmacodynamics principles, statistical principles including mixed effects modeling, theory governing model building and qualification and ability to use software for modeling and visualization (SAS, Splus, NONMEM, etc) are expected. Good communication and writing skills are critical. Opportunities to learn and contribute in a dynamic team, to influence key regulatory decisions, and to conduct and publish research in related areas are abundant. In general, FDA can sponsor eligible candidates for working VISA (H1b). Please state your immigration status in the CV (e.g.: F1, H1b, permanent resident or US citizen). Please forward your resume to: Joga Gobburu, PhD Director (acting), Pharmacometrics Office of Clinical Pharmacology, CDER, FDA Email: [EMAIL PROTECTED] Phone : 301.796.1534 Fax : 301.796.9738 Venkatesh Atul Bhattaram Pharmacometrics US Food and Drug Administration "The contents of this message are mine personally and do not necessarily reflect any position of the Government or the Food and Drug Administration."