Dear colleagues:
The Division of Pharmacometrics at FDA is hiring pharmacometricians with
responsibilities to develop, evaluate, and report on physiologically based
pharmacokinetics (PBPK) models; to identify opportunities for innovative study
designs; and to interact with sponsors during the reviews for investigational
new drugs, biologics license applications, and new drug applications. The duty
station is in Silver Spring, Maryland.
Minimum requirements include a PhD, or other professional doctorate in PBPK, or
Clinical Pharmacology, and hands-on experience with PBPK modeling and
simulation. Good communication and interpersonal skills are needed for
successfully working in multidisciplinary review teams. Candidates should have
continuous residence in the US for the last 3 years. Opportunities are
available for new graduates or those with postdoctoral, industry, or government
experience.
The Division of Pharmacometrics is multidisciplinary and consists of
quantitative clinical pharmacologists, statisticians, data scientists, 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 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 regimens likely to
be successful in all patients.
* Research is conducted:
* to create new knowledge based on the data available at the FDA and
literature to inform better regulatory and drug development decisions.
* to create new models or confirm prior models of disease change, placebo
effect, drop-outs, and drug effect.
* to help determine the value of biomarkers across clinical trials for a
given disease or drug class to reflect change in primary clinical endpoints.
For more information, please go to
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm167032.htm
To Apply
Interested candidates should submit resume to:
[email protected]<mailto:[email protected]>
Hao Zhu, Ph.D.
Division Director
Division of Pharmacometrics
FDA/CDER/OTS/OCP
.