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 multiple positions available including
Oak Ridge Institute for Science (ORISE) post-doctoral and full-time
employee (FTE) positions. These positions provide the opportunity to apply
quantitative analysis to address various issues related to therapeutic
equivalence. We want to use the large amount of data available to FDA to
launch innovative quantitative models and enable the use of modeling and
simulation to improve regulatory decision making for generic drugs.
Areas of interest for these positions include:
· Modeling and simulation of modified release solid oral products
(including absorption models, in vitro - in vivo correlations and PK/PD
modeling) to ensure that bioequivalence recommendations from OGD are
consistent with known pharmacodynamic (PD) or exposure-response
relationships.
· 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
of administration.
· PK/PD modeling of complex drug products and clinical trial
simulation
· Establishing the generic specific safety surveillance function
and developing/applying novel analysis approach to detect and assess safety
signals of generic products.
· Establishing the group for systems pharmacology research at
FDA/OGD.
· Establishing data warehouse managed by DQMM that enables systemic
and efficient scientific/regulatory research at FDA regarding background
scientific information for approved NDAs/ANDAs, safety profiles,
cost-effectiveness assessment, and generic opportunities.
The DQMM conducts modeling and simulation research to support the
evaluation of generic products, to enable generic version of new classes of
pharmaceutical products, and to respond to scientific challenges in the
review of generic drug applications. Many of the scientific challenges of
interest were identified in the FY 2015 GDUFA Regulatory Research
Priorities:
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm370952.htm
Qualifications:
· Ph.D., M.D., Pharm.D., or other professional doctorate in PKPD,
Clinical Pharmacology, Pharmaceutical Sciences, Statistics, Life Science,
or Engineering.
· 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 biopharmaceutics, and modeling and simulation
principles.
· Good communication and interpersonal skills.
For ORISE positions, the initial appointment is for one year. The salary
range is approximately $70,000-$80,000 per year depending on qualification.
For FTE positions, the salary range is complied with Federal General
Schedule (GS).
Location:
Silver Spring, MD
Contact:
Send CV to Lanyan (Lucy) Fang, Ph.D.
[email protected] <[email protected]>
Applications should be sent by May 1st, 2015 to receive full consideration.