The Division of Pharmacometrics at the FDA is hiring pharmacometricians with
responsibilities to develop, evaluate, and report on models that describe
compound- or disease-related behaviors using a variety of tools and approaches;
to identify opportunities for innovative study designs; and to interact with
sponsors in the course of investigational new drugs and new drug applications
as part of the drug approval process. Minimum requirements include an earned
Ph.D. or other professional doctorate in PKPD, Statistics, Engineering, or
Clinical Pharmacology, hands-on experience with modeling and simulation
software (e.g. NONMEM, SAS, Splus/R, Trial Simulator, WinBUGs, Phoenix,
Monolix, GastroPlus, PKSIM, SimCYP, etc.) and good knowledge of PK/PD, modeling
principles and statistics. In addition, successful candidates should have good
communication (written and oral) and interpersonal skills in order to
successfully work in a cross-functional setting.
Interested candidates would be part of a multidisciplinary team that is
represented by quantitative clinical pharmacologists, statisticians, engineers,
experts in physiologically based pharmacokinetic systems and data management
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 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 unique
data available at the FDA (i.e. prior submissions) and literature to inform
better regulatory decisions by the FDA and drug development decisions by
sponsors. Research is conducted to create new models or confirm prior models of
disease 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 endpoints.
An important component of the research is training future scientists. In
addition, the staff members often work on internal and external collaborative
projects.
Opportunities are available for new graduates or those with postdoctoral,
industry, or government experience.
To Apply
Interested candidates should submit Curriculum Vitae to: [email protected]