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ORISE Fellow Positions available within the Food and Drug Administration (FDA)

From: Lucy Fang <lanyan.fang>
Date: Thu, 8 Sep 2016 09:14:02 -0400

*Modeling and Simulation Positions at FDA*

Position Description:

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 has 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 postmarketing
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

Research at DQMM includes, but not limited to, the following areas:

· Modeling and simulation of modified release solid oral produ=
(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=
products and clinical trial simulation to aid risk-based bioequivalence

· Conventional and model-based meta-analysis on drugs within s=
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 under=
and predict drug actions underlying both therapeutic effect and adverse

· 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.


· 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

· Hands-on experience with modeling and simulation software (e=
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, a=
interpersonal skills.

For ORISE positions, the initial appointment is for one year.


Silver Spring, MD


Send CV to Jae Wook Yoo, Pharm D


Applications should be sent by 9/30/2016 to receive full consideration.

Lucy Fang

Received on Thu Sep 08 2016 - 09:14:02 EDT

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