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: dpm-cont...@fda.hhs.gov<mailto:dpm-cont...@fda.hhs.gov> Hao Zhu, Ph.D. Division Director Division of Pharmacometrics FDA/CDER/OTS/OCP .
