Dear all, Multiple modeling and data analytics full time employment opportunities are available in the Division of Quantitative Methods and Modeling (DQMM) in the Office of Research and Standards (ORS) within the Office of Generic Drugs (OGD) in the U.S. Food and Drug Administration (FDA) located in Silver Spring, MD 20903. The DQMM is a fast-paced, dynamic scientific environment with opportunities to work with dedicated, energetic senior scientists and researchers who want to make a difference and improve public health. We conduct Generic Drug User Fee Amendments (GDUFA) regulatory science and research activities based on quantitative clinical pharmacology, physiologically based pharmacokinetic models, PK profile assessment for modified release products, big data analytics including post market product performance evaluations, and novel quantitative methods for equivalence assessment. The relevant regulatory activities include but are not limited to general and product specific guidance development, abbreviated new drug application (ANDA) review consults, citizen petitions, controlled correspondence, pre-ANDA meetings, and post-marketing safety surveillance. We coordinate modeling, simulation, data analysis, and data mining and establish the scientific computing infrastructure for OGD. In addition, we develop innovative quantitative approaches to improve regulatory decision making for generic drugs by fully utilizing the extensive resources available to FDA. Some of the exciting areas that we are involved are as follows: · Model-based delivery system assessment
· Innovative approaches to establish active ingredient sameness/pharmaceutical equivalence for complex drug substances · In vitro bioequivalence analyses taking into consideration of high batch to batch variation · Clinical trial simulation of clinical endpoint (PK and/or PD) bioequivalence study, average bioequivalence, reference scale average bioequivalence study (for narrow therapeutic index drugs and highly variable drugs), adaptive study design, Bayesian bioequivalence, power and sample size analysis · 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 · 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 · 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 · Developing big data techniques to predict FDA workload · 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 The incumbent provides scientific expertise in one or more of the following areas: Quantitative clinical pharmacology Physiologically based pharmacokinetic modeling for systemically or locally acting products Data analytics for health outcomes and big data Novel methodologies for bioequivalence evaluation and study design Formulation science and technology Desired Qualifications: · Ph.D., M.D., Pharm.D., or other qualified scientists holding advanced degree(s) such as Clinical Pharmacology, Pharmaceutical Sciences, Pharmacometrics, Chemistry, Statistics, and/or Engineering. · Hands-on experience with certain modeling and simulation software (e.g., NONMEM, SAS, Splus/R, Phoenix, Monolix, MATLAB, C++, GastroPlus, Simcyp, and PKSim etc.) · Experience in pharmaceutical abuse-deterrent opioid formulation development, physical manipulation methods, and analysis of in vitro (dissolution) and in vivo (pharmacokinetics) results related to abuse deterrence properties · Experience in pharmaceutical dosage form development, technology transfer and a strong desire to analyze and interpret in vitro (dissolution) and in vivo (pharmacokinetics) results related to product development of complex oral dosage forms. · Experience in methodology development in linear and nonlinear mixed effect modeling, bioequivalence analysis, sequential and adaptive study design, power and sample size estimations. · Broad technical knowledge about biopharmaceutics, formulation, dissolution, stability and manufacturability · Good knowledge of formulation design, biopharmaceutics, data analysis and/or modeling and simulation principles · Strong organizational and documentation skills, scientific problem-solving skills · Good scientific writing, communication, critical thinking, and interpersonal skills Additional Qualifications for Senior Scientists/Reviewers, Scientific Leads or Team Leads: The incumbent should have a minimum of 3 years of experience in an industrial or regulatory setting with a well-established record in the relevant modeling or data analytics field. The incumbent prepares a comprehensive summary of his/her reviews and presents substantive recommendations for revision/acceptance/rejection. The incumbent is responsible for planning, coordinating, and evaluating the programs and activities of the Division for the professional scientific discipline for which he/she is responsible. The responsibility requires the scientist to maintain close personal contact with the “state of the science” to promote the most advanced theories and practices in the scientific field into divisional and ORS programs. The incumbent concentrates on complex, long-term, and emerging problems related to generic product development and regulation. The scientist keeps fully abreast of crucial and precedent setting cases under review within the division and regulated industry, as well as related cases in ORS, and briefs the Division Director, the Division Deputy Director and the team on all scientific interpretations and analyses. The incumbent participates in meetings within the division and with other divisions and offices in OGD and serves as expert advisor on problems related to his/her area of expertise. This requires a continuing knowledge of the research in both the scientific discipline and the regulated industry as these studies impact the area of science for which the scientist is responsible. The incumbent leads or serves as a member of divisional task forces and study groups called to consider problems or provide direction in scientific expertise. As required, the incumbent conceives the mission for such groups, develops propositions for study and speaks for the Division, ORS, OGD on issues in the scientific discipline. When appropriate, represents discipline to the professional and academic communities and to regulated industry. He/she meets with representatives of the regulated firms with problems in the scientific discipline. He/she maintains continuing liaison with other organizations within ORS, OGD, CDER and the Agency and other agencies. He/she provides consultations, opinions, and endorsements regarding the scientific discipline. The incumbent coaches the team in the selection and application of appropriate problem-solving quantitative methods and techniques, provides advice on work methods, practices and procedures, and assists the team and/or individual members in identifying the parameters of a viable solution. The incumbent participates in identifying, distributing and balancing workload and tasks among employees in accordance with established work flow, skill level and/or occupational specialization. He/she makes adjustments to the workload in accordance with established priorities to ensure timely and successful completion of assigned team tasks. He/she ensures that each employee has an integral role in developing the final team product. If you would like to be considered for these opportunities, please submit a letter of interest and a copy of your CV/resume tojeannie.caldw...@fda.hhs.gov Best regards， Kevin
