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

From: Gonzalez Sales, Mario <Mario.Gonzalezsales>
Date: Wed, 16 Nov 2016 14:51:40 +0000

Dear NONMEM users,

The Division of Quantitative Methods and Modeling (DQMM) in the Office of R=
esearch 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 Ins=
titute for Science (ORISE) fellow positions available.

DQMM provides expertise in advanced quantitative methods for the generic dr=
ug program and conducts GDUFA (Generic Drug User Fee Amendments 2012) regul=
atory science and research activities based on quantitative approaches, whi=
ch include guidance development, abbreviated new drug application (ANDA) re=
views, citizen petitions, controlled correspondence, pre-ANDA meetings, and=
 methodology development for bioequivalence evaluation, active ingredient s=
ameness demonstration and post marketing safety surveillance. This Divisio=
n coordinates modeling, simulation, data analysis and data mining and estab=
lishes the scientific computing infrastructure for OGD. DQMM is also develo=
ping innovative quantitative approaches to improve regulatory decision maki=
ng 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 suppo=
rt 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 pharmacoki=
netic/pharmacodynamic [PK/PD] modeling) to ensure the consistency and quali=
ty of bioequivalence recommendations from OGD.

* Model-based delivery system assessment.

* Innovative approaches to establish active ingredient sameness/pha=
rmaceutical equivalence for complex drug substances.

* In vitro bioequivalence analyses.

* Application of physiologically based pharmacokinetic (PBPK) model=
s for non-oral drug products to help develop new bioequivalence methods for=
 locally acting drug products administered via non-oral routes of administr=

* PK/PD modeling of narrow therapeutic index drugs and complex drug=
 products and clinical trial simulation to aid risk-based bioequivalence ev=

* Conventional and model-based meta-analysis on drugs within same c=
lass or different classes.

* Conducting safety surveillance by developing/applying novel analy=
sis 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 re=

* Establishing data infrastructure to increase ANDA review efficien=
cy and quality by providing integrated and readily searchable information b=
ased on available NDAs and ANDA datasets regarding drug efficacy and safety=


* Ph.D., M.D., Pharm.D., or other qualified scientists holding adva=
nced degree(s) in pharmacometrics, Clinical Pharmacology, Pharmaceutical Sc=
iences, Chemistry, Statistics, Life Science, or Engineering.

* Hands-on experience with modeling and simulation software (e.g. N=
ONMEM, SAS, Splus/R, Phoenix, Monolix, MATLAB, C++, GastroPlus, Simcyp, PKS=
im, etc.).

* Good knowledge of formulation design, biopharmaceutics, data anal=
ysis and/or modeling and simulation principles.

* Good scientific writing, communication, critical thinking, and in=
terpersonal skills.

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


Silver Spring, MD


Send CV to Jeff Tworzyanski.


Applications should be sent by 12/16/2016 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
Email: mario.gonzalezsales

Received on Wed Nov 16 2016 - 09:51:40 EST

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