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[NMusers] Job Opportunities at FDA

From: Lucy Fang <>
Date: Tue, 16 Jan 2018 09:24:29 -0500

Dear all,

Multiple modeling and data analytics full time employment opportunities are
available at 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 GDUFA
(Generic Drug User Fee Amendments) 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 not limited to general and
product specific guidance development, abbreviated new drug application
(ANDA) review consults, citizen petitions, controlled correspondence,
and pre-ANDA
meetings, and postmarketing safety surveillance. We coordinate modeling,
simulation, data analysis, and data mining and establishes 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 large amount of data 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

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

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

· Conventional and model-based meta-analysis on drugs within sam=
class or different classes

· Modeling and simulation of modified release solid oral product=
(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 as=
safety signals of generic products

· Developing systems pharmacology-based methodologies to underst=
and predict drug actions underlying both therapeutic effect and adverse

· Developing big data techniques to predict FDA workload

· Establishing data infrastructure to increase ANDA review effic=
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
expertise areas

a. Physiologically based pharmacokinetic modeling for systemically or
locally acting products

b. Quantitative clinical pharmacology

c. Data analytics for health outcomes and big data

d. Novel methodologies for bioequivalence evaluation and study design

e. Formulation science and technology

*Desired 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 certain modeling and simulation software
(e.g., NONMEM,
SAS, Splus/R, Phoenix, Monolix, MATLAB, C++, GastroPlus, Simcyp, PKSim,

-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.

-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

-Good scientific writing, communication, critical thinking, and interperson=

Additional Qualifications for Team Leads:

1. 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.

2. The incumbent prepares a comprehensive summary of his/her reviews
and presents substantive recommendations for revision/acceptance/rejection.

3. 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 =
of the science” to inculcate the most advanced theories and practic=
es in
the scientific field into the Divisional programs and into the ORS programs=

4. 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 in the regulated industry as well as related
cases in the ORS, and briefs the Division Director, the Division Deputy
Director and the team on all scientific interpretations and analyses.

5. 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 both in the scientific discipline and in the
regulated industry as those studies impact on the area of science for which
the scientist is responsible.

6. The incumbent leads or serves as a member of Division task forces
and study groups called to consider problems or directions in the area of
scientific expertise. As required, conceives of 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
this discipline to the professional and academic communities and to the
regulated industry. Meets with representatives of the regulated firms with
particular problems in the scientific discipline. Maintains continuing
liaison with other organizations within ORS, OGD, CDER and the Agency and
other agencies. Provides consultations, opinions, and endorsements
regarding the scientific discipline.

7. 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 assist the team and/or
individual members in identifying the parameters of a viable solution.

8. Participates in identifying, distributing and balancing workload and
tasks among employees in accordance with established work flow, skill level
and/or occupational specialization; makes adjustments to accomplish the
workload in accordance with established priorities to ensure timely
accomplishment of assigned team tasks; and ensuring 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 your interest and a copy of your CV/resume to



Received on Tue Jan 16 2018 - 09:24:29 EST

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