New ORISE fellow positions available at the Division of Quantitative Methods and Modeling of the Food and Drug Administration

Dear NONMEM users, The Division of Quantitative Methods and Modeling (DQMM) in the Office of Research and Standards (ORS) within the Office of Generic Drugs (OGD) of the Food and Drug Administration is growing fast and we have new Oak Ridge Institute for Science (ORISE) fellow positions available. DQMM provides expertise in advanced quantitative methods for the generic drug program and conducts GDUFA (Generic Drug User Fee Amendments 2012) regulatory science and research activities based on quantitative approaches, which include guidance development, abbreviated new drug application (ANDA) reviews, citizen petitions, controlled correspondence, pre-ANDA meetings, and methodology development for bioequivalence evaluation, active ingredient sameness demonstration and post marketing safety surveillance. This Division coordinates modeling, simulation, data analysis and data mining and establishes the scientific computing infrastructure for OGD. DQMM is also developing innovative quantitative approaches to improve regulatory decision making for generic drugs by fully utilizing the large amount of data available to FDA. The ORISE position(s) at DQMM provides an outstanding opportunity to learn and apply quantitative analysis, modeling, and simulation to support the aforementioned activities. Research at DQMM includes, but not limited to, the following areas: * Modeling and simulation of modified release solid oral products (including absorption models, in vitro - in vivo correlations and pharmacokinetic/pharmacodynamic [PK/PD] modeling) to ensure the consistency and quality of bioequivalence recommendations from OGD. * Model-based delivery system assessment. * Innovative approaches to establish active ingredient sameness/pharmaceutical equivalence for complex drug substances. * In vitro bioequivalence analyses. * Application of physiologically based pharmacokinetic (PBPK) models for non-oral drug products to help develop new bioequivalence methods for locally acting drug products administered via non-oral routes of administration. * PK/PD modeling of narrow therapeutic index drugs and complex drug products and clinical trial simulation to aid risk-based bioequivalence evaluation. * Conventional and model-based meta-analysis on drugs within same class or different classes. * Conducting safety surveillance by developing/applying novel analysis approaches to detect and assess safety signals of generic products. * Developing systems pharmacology-based methodologies to understand and predict drug actions underlying both therapeutic effect and adverse reactions. * Establishing data infrastructure to increase ANDA review efficiency and quality by providing integrated and readily searchable information based on available NDAs and ANDA datasets regarding drug efficacy and safety profiles. Qualifications: * Ph.D., M.D., Pharm.D., or other qualified scientists holding advanced degree(s) in pharmacometrics, Clinical Pharmacology, Pharmaceutical Sciences, Chemistry, Statistics, Life Science, or Engineering. * Hands-on experience with modeling and simulation software (e.g. NONMEM, SAS, Splus/R, Phoenix, Monolix, MATLAB, C++, GastroPlus, Simcyp, PKSim, etc.). * Good knowledge of formulation design, biopharmaceutics, data analysis and/or modeling and simulation principles. * Good scientific writing, communication, critical thinking, and interpersonal skills. For ORISE positions, the initial appointment is for one year. Location: Silver Spring, MD Contact: Please send CV to Jae Wook Yoo [email protected]<mailto:[email protected]> Best regards, Mario Gonzalez Sales, Ph.D Division of Quantitative Methods and Modelling ORS/OGD/CDER/FDA 10903 New Hampshire Ave., Bldg 75, Room 4695 Silver Spring, MD 20993 Phone: (301)-796-7365 Email: [email protected]<mailto:[email protected]>