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FDA Pharmacometrics is looking for eligible scientists

From: Bhattaram, Atul <atul.bhattaram>
Date: Wed, 18 Apr 2007 11:49:35 -0400

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: jogarao.gobburu
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."



Received on Wed Apr 18 2007 - 11:49:35 EDT

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