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

From: Mario Gonzalez Sales <>
Date: Fri, 9 Sep 2016 14:19:13 +0200

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 Insti=
tute =
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, abbreviate=
d new =
drug application (ANDA) reviews, citizen petitions, controlled correspo=
ndence, =
pre-ANDA meetings, and methodology development for bioequivalence evaluat=
ion, =
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 aforemen=
tioned =
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 an=
d =
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 o=
f =
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 searchabl=
e =
information based on available NDAs and ANDA datasets regarding drug effica=
cy =
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 En=
gineering. =

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: =

Send CV to Jae Wook Yoo, Pharm D = =

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

Mario =
Gonzalez Sales, Ph.D =

Division =
of Quantitative Methods and Modelling =


10903 =
New Hampshire Ave., Bldg 75, Room 4695 =

Silver =
Spring, MD 20993 =

Phone: =
(301)-796-7365 =

CallSend SMSAdd to SkypeYou'll need Skype CreditFree via SkypeCallSend SMSC=
all from mobileAdd to SkypeYou'll need Skype CreditFree via SkypeCallSend S=
MSCall from mobileAdd to SkypeYou'll need Skype CreditFree via Skype =

Received on Fri Sep 09 2016 - 08:19:13 EDT

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