Dear all,
We are happy to announce the following job opportunities at US FDA.
Job opportunities at Division of Quantitative Methods and Modeling (DQMM),
ORS/OGD/CDER.
1. Team lead, Quantitative Clinical Pharmacology. This is a key role
residing in DQMM and Office of Research and Standards that offers career
opportunity, ownership, and regulatory and industrial impact. In this role,
the incumbent will
a. Lead and provide quantitative method support for guidance
development, abbreviated new drug application (ANDA) reviews, citizen
petitions, controlled correspondence, and pre-ANDA meetings.
b. Respond to generic drug review and product life cycle management
issues related to quantitative methods, modeling and simulation.
c. Provide modeling and simulation tools to support the development of
new quality and bioequivalence standards or guidance related to generic
drug approvals.
d. Serve as FDA project officer and provide scientific oversight on
collaborative modeling and simulation projects with external experts in the
field (please refer to FDA sponsored modeling and simulation grants and
contracts for more information)
e. Develop, assign, and approve program goals for the team including
managing workload and tasks among employees, monitoring and reporting on
the status and progress of work priorities, and coordinating team work
plans, products, and services.
f. Plan and coordinate the generic drug regulatory activities
including evaluating the feasibility of the initial plan, monitoring and
adjusting the conduct of the study, and implementing research outcomes into
new regulatory policy or guidance.
g. Develop propositions for study, create new projects and procedures,
conduct satisfactory quality control on review, consult, and communication
documents of different natures, and prepare scientific texts and technical
reference.
h. Maintain continuing liaison internally and with other organizations,
which include briefing the Division Director/Deputy and the team on all
scientific interpretations and analyses, represent the discipline to the
professional and academic communities, provide consultations, opinions, and
endorsements regarding the scientific discipline.
Requirements:
a. PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics,
Engineering or other suitable post-graduate qualification.
b. 3-15 years of regulatory/industry experience in quantitative
clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics.
c. Excellent written and verbal communication skills.
d. Demonstrated presentation skills.
2. Oak Ridge Institute for Science (ORISE) fellows. DQMM have multiple
opening for fellows to participate in research activities that support our
mission of providing high quality generic drugs to the American
consumer. In the past three and half years, DQMM has supplied 20-30
outstanding scientists/researchers to new and generic drug companies, CRO,
consulting firm, and other offices within FDA including Office of Clinical
Pharmacology, Office of Bioequivalence, Office of Pharmaceutical Quality,
and Office of Surveillance and Epidemiology.
Requirements:
a. PhD in Pharmaceutical Sciences, Clinical Pharmacology,
Pharmacokinetics, Pharmacometrics, Engineering, Statistics, Data Science,
or other suitable post-graduate qualification.
b. Within 5 years post graduation.
c. Excellent communication skills and critical thinking
d. Demonstrated presentation skills
3. Oak Ridge Institute for Science (ORISE) fellow to develop Bayesian
base BE assessment method. This fellowship will be closely co-mentored by
a. Carl Peck, MD, UCSF & NDA Partners
b. Greg Campbell, PhD, GCStat Consulting, NDA Partners
c. Liang Zhao, PhD, DQMM/ORS/OGD/CDER/FDA
Requirements: Same as above
For the ORISE program, please also refer to
https://www.zintellect.com/Posting/details/3206for more details.
For the Team Lead position, please also send your C.V. to Liang.Zhao
@FDA.hhs.gov http://mailto:[email protected]/ or to
[email protected] http://mailto:[email protected]/
*Background on the organization*
In the United States, 9 out of 10 prescriptions filled are for generic
drugs. Increasing the availability of generic drugs helps to create
competition in the marketplace, which then helps to make treatment more
affordable and increases access to healthcare for more patients. The
Generic Drug User Fee Amendments of (GDUFA) regulatory science program and
research activities support the development of new methodologies and tools.
These methodologies and tools help establish drug equivalence standards and
the development of, and access to, generic drug products. Between 2013 and
2017, Office Research and Standards awarded 36 research contracts and 69
grants for innovative research projects on generics. These contracts and
grants resulted in significant accomplishments, from developing the
scientific basis to support new and revised guidances for industry to
refining methods for the evaluation of generic drug products.
Specifically, DQMM provides expertise in advanced quantitative methods for
the generic drug research program and conducts GDUFA regulatory science and
research activities based on quantitative approaches. Some of the
responsibilities residing in DQMM include providing quantitative method
support for 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, big data analytics, and postmarketing
safety surveillance. This Division coordinates modeling, simulation, data
analysis and data mining for OGD. DQMM is also actively engaging developing
innovative quantitative approaches to improve regulatory decision making by
fully utilizing the large amount of data available to FDA which can
critically impact both generic and new drug developments.
Some details regarding GDUFA regulatory science and research activities can
be assess at
https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm597035.htm#directors
https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm585393.htm
A general understanding of GDUFAII program can be found on line at
https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm580458.htm
Thanks,
Lucy