[NMusers] Job Opportunity at the Division of Pharmacometrics, FDA

From: Zhu, Hao <Hao.Zhu_at_fda.hhs.gov>
Date: Wed, 8 Aug 2018 23:35:40 +0000

Dear colleagues:
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 during the review for investigational new drugs and new drug a=
pplications. Minimum requirements include an earned Ph.D. or other profess=
ional doctorate in PKPD, Statistics, Engineering, or Clinical Pharmacology,=
 hands-on experience with modeling and simulation software (e.g. NONMEM, SA=
S, Splus/R, Trial Simulator, WinBUGs, Phoenix, Monolix, GastroPlus, PKSIM, =
SimCYP, etc.), and good knowledge of PK/PD modeling principles and statisti=
cs. Good communication and interpersonal skills are needed for successfully=
 working in multidisciplinary review teams. Candidates should have continuo=
us residence in the US for the last 3 years. Opportunities are available fo=
r new graduates or those with postdoctoral, industry, or government experie=
nce.

The Division of Pharmacometrics is multidisciplinary and consists of quanti=
tative clinical pharmacologists, statisticians, and engineers who work very=
 closely in cross-functional review 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.
For more information about FDA Division of Pharmacometrics, please go to ht=
tp://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/=
CDER/ucm167032.htm

To Apply
Interested candidates should submit Curriculum Vitae to:
Yaning.Wang_at_fda.hhs.gov<mailto:Yaning.Wang_at_fda.hhs.gov> and Hao.Zhu_at_fda.hhs=
.gov<mailto:Hao.Zhu_at_fda.hhs.gov>


Hao Zhu, Ph.D.
Deputy Director
Division of Pharmacometrics
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration
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 Wed Aug 08 2018 - 19:35:40 EDT

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