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 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, R, WinBUGs, Phoenix, Monolix, GastroPlus, PKSIM, SimCYP, etc.) and good knowledge of PK/PD modeling principles and statistics.
The Division of Pharmacometrics is multidisciplinary and consists of quantitative clinical pharmacologists, statisticians, engineers, pharmacokinetic scientists with physiologically based pharmacokinetic expertise who work very closely in cross-functional review teams. Good communication and interpersonal skills are needed for successfully working in multidisciplinary 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 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 often works 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] For more information about FDA Division of Pharmacometrics, please go to http://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: [email protected]<mailto:[email protected]> Disclaimer: The contents of this message are mine personally and do not necessarily reflect any position of the Government or the Food and Drug Administration.
