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Job openings at FDA

From: Wang, Yaning <Yaning.Wang>
Date: Mon, 30 Nov 2015 20:18:11 +0000

The Division of Pharmacometrics at the FDA is hiring pharmacometricians wit=
h responsibilities to develop, evaluate, and report on models that describe=
 compound- or disease-related behaviors using a variety of tools and approa=
ches; to identify opportunities for innovative study designs; and to intera=
ct with sponsors in the course of investigational new drugs and new drug ap=
plications as part of the drug approval process. Minimum requirements inclu=
de an earned Ph.D. or other professional doctorate in PKPD, Statistics, Eng=
ineering, or Clinical Pharmacology, hands-on experience with modeling and s=
imulation software (e.g. NONMEM, SAS, Splus/R, Trial Simulator, WinBUGs, Ph=
oenix, Monolix, GastroPlus, PKSIM, SimCYP, etc.) and good knowledge of PK/P=
D, modeling principles and statistics. In addition, successful candidates s=
hould have good communication (written and oral) and interpersonal skills i=
n order to successfully work in a cross-functional setting.
Interested candidates would be part of a multidisciplinary team that is re=
presented by quantitative clinical pharmacologists, statisticians, engineer=
s, experts in physiologically based pharmacokinetic systems and data manage=
ment experts who work very closely in review teams.

At the FDA, pharmacometric work is conducted with three objectives:
* To approve and label the drug product with particular attenti=
on to drug dosing at the individual and population levels.
* Provide advice on trial design and development path decisions=
 to sponsors where the focus is both trial success and rendering dosage reg=
imens likely to be successful in all patients.
* Research is conducted to create new knowledge based on the un=
ique data available at the FDA (i.e. prior submissions) and literature to i=
nform better regulatory decisions by the FDA and drug development decisions=
 by sponsors. Research is conducted to create new models or confirm prior m=
odels of disease change, placebo effect, drop-outs, and drug effect. Resear=
ch is also conducted to help determine the value of biomarkers across clini=
cal trials for a given disease or drug class to reflect change in primary c=
linical endpoints. An important component of the research is training futur=
e scientists. In addition, the staff members often work on internal and ext=
ernal collaborative projects.
Opportunities are available for new graduates or those with postdoctoral, i=
ndustry, or government experience.

To Apply
Interested candidates should submit Curriculum Vitae to:

Received on Mon Nov 30 2015 - 15:18:11 EST

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