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Open Positions at FDA - Quantitative Clinical Pharmacology

From: Lucy Fang <lanyan.fang>
Date: Wed, 6 Oct 2021 20:43:55 -0400

*Job opportunities at the Division of Quantitative Methods and Modeling
(DQMM), Office of Research and Standards/Office of Generic Drugs at the
FDA’s Center for Drug Evaluation and Research.*

1. *Junior/Senior Reviewer, Quantitative Clinical Pharmacology.* This
position offers a unique combination of regulatory and research

The incumbent will:

· Lead and provide quantitative method support for developmen=
t of
regulatory guidance and assessment of abbreviated new drug applications
(ANDAs), citizen petitions, controlled correspondence, and pre-ANDA

· Provide consults on complex issues in generic drug review a=
product life cycle management related to quantitative methods, modeling,
and simulation.

· Apply modeling and simulation tools to support the developm=
of new quality and bioequivalence standards or guidance documents for
generic drug approvals.

· Serve as FDA project officer and provide scientific oversig=
ht on
collaborative modeling and simulation projects with external experts in the
field. Please refer to FDA GDUFA sponsored modeling and simulation grants
and contracts for more information.

· Plan and coordinate generic drug regulatory activities (e.g=
evaluating the feasibility of the initial plan, monitoring and adjusting
the conduct of a study, and implementing research outcomes into new
regulatory policy or guidance).

· Develop propositions for study, create new projects and
procedures, conduct satisfactory quality control on several different types
of documents (e.g. review, consult, and communication documents), and
prepare scientific texts and technical references.

· Maintain continuing liaison both internally and externally,=
as briefing the Division Director/Deputy and the team on all scientific
interpretations and analyses, represent the discipline to professional and
academic communities, provide consultations, opinions, and endorsements
regarding the scientific discipline.


· PhD in clinical pharmacology, pharmacokinetics (PK),
pharmacometrics, engineering or other suitable post-graduate qualification.

· 3-15 years of regulatory/industry experience in quantitativ=
clinical pharmacology, and/or clinical pharmacokinetics/pharmacodynamics
(PK/PD), and/or pharmacometrics.

· Excellent written and verbal communication skills.

· Demonstrated presentation skills.

   1. *Oak Ridge Institute for Science (ORISE) fellows.* DQMM has multiple
   openings for trainees to participate in research activities that support
   our mission of providing high quality generic drugs to the American
   public. Many of the outstanding scientists/researchers trained in DQMM h=
   now joined new and generic drug companies, clinical research organizatio=
   (CROs), consulting firms, and other offices within FDA (e.g. Office of
   Clinical Pharmacology, Office of Bioequivalence, Office of Pharmaceutica=
   Quality, and Office of Surveillance and Epidemiology).

Under the guidance of a mentor, the ORISE fellow(s) will:

· gain knowledge about the use of modeling and simulation too=
for bioequivalence assessment.

· share the results of their research by preparing scientific
texts, technical references, and posters and presentations at conferences.

· collaborate with cross-disciplinary teams and liaise both
internally and externally (e.g. , presenting results at team briefings,
workshops, etc.).

· be given opportunities to publish results in peer-reviewed
scientific journals.


· PhD in pharmaceutical sciences, clinical pharmacology,
pharmacokinetics, pharmacometrics, engineering, statistics, data science,
or other suitable post-graduate qualification.

· PhD received within the last 60 months.

· Excellent communication skills and critical thinking.

· Demonstrated presentation skills.

 If you are interested, please send your CV to Miyoung Yoon at


Lucy Fang

Received on Wed Oct 06 2021 - 20:43:55 EDT

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