Dear colleagues:
The Division of Pharmacometrics at FDA is hiring pharmacometricians with
responsibilities to develop, evaluate, and report on models that describe
compound- or disease-related behaviors; 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 PKPD,
Data Science, Mathematics, Engineering, or Clinical Pharmacology, hands-on
experience with modeling and simulation software, and good knowledge of PK/PD
modeling principles and statistics. 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
OCP/OTS/CDER/FDA