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RE: Opportunities at FDA/Division Of Pharmacometrics

From: Wang, Yaning <Yaning.Wang>
Date: Thu, 7 Feb 2019 16:28:37 +0000

Candidates should have continuous residence in the US for the last 3 years.

From: Wang, Yaning
Sent: Thursday, February 7, 2019 12:08 AM
To: nmusers
Subject: Opportunities at FDA/Division Of Pharmacometrics


The Division of Pharmacometrics at FDA is hiring pharmacometricians with re=
sponsibilities to develop, evaluate, and report on models that describe com=
pound- or disease-related behaviors using a variety of tools and approaches=
; to identify opportunities for innovative study designs; and to interact w=
ith sponsors in the course of investigational new drugs and new drug applic=
ations as part of the drug approval process. Minimum requirements include a=
n earned Ph.D. or other professional doctorate in PKPD, Statistics, Enginee=
ring, or Clinical Pharmacology, hands-on experience with modeling and simul=
ation software (e.g. NONMEM, SAS, R, WinBUGs, Phoenix, Monolix, GastroPlus,=
 PKSIM, SimCYP, etc.) and good knowledge of PK/PD modeling principles and s=
tatistics.

The Division of Pharmacometrics is multidisciplinary and consists of quanti=
tative clinical pharmacologists, statisticians, engineers, pharmacokinetic =
scientists with physiologically based pharmacokinetic expertise who work ve=
ry closely in cross-functional review teams. Good communication and interpe=
rsonal skills are needed for successfully working in multidisciplinary revi=
ew teams.

At the FDA, pharmacometric work is conducted with three objectives:
  * Approve and label the drug product with particular attention to drug do=
sing at the individual and population levels.
  * Provide advice on trial design and development path decisions to sponso=
rs where the focus is both trial success and rendering dosage regimens like=
ly to be successful in all patients.
  * Research is conducted to create new knowledge based on the unique data =
available at the FDA (i.e. prior submissions) and literature to inform bett=
er regulatory decisions by the FDA and drug development decisions by sponso=
rs. Research is conducted to create new models or confirm prior models of d=
isease change, placebo effect, drop-outs, and drug effect. Research is also=
 conducted to help determine the value of biomarkers across clinical trials=
 for a given disease or drug class to reflect change in primary clinical en=
dpoints. An important component of the research is training future scientis=
ts. In addition, the staff often works on internal and external collaborati=
ve 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:
Hao.Zhu


For more information about FDA Division of Pharmacometrics, please go to ht=
tp://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/=
CDER/ucm167032.htm

Yaning Wang, Ph.D.
Director
Division of Pharmacometrics
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration
Phone: 301-796-1624
Email: yaning.wang
Disclaimer: The contents of this message are mine personally and do not nec=
essarily reflect any position of the Government or the Food and Drug Admini=
stration.


Received on Thu Feb 07 2019 - 11:28:37 EST

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