[ascct] Modeling and Simulation Positions at the Office of Generic Drugs, FDA
- From: Kristie Sullivan <KSullivan@xxxxxxxx>
- To: "ascct@xxxxxxxxxxxxx" <ascct@xxxxxxxxxxxxx>
- Date: Fri, 21 Nov 2014 01:29:22 -0500
Modeling and Simulation Positions at the Office of Generic Drugs, FDA
Responsibilities:
Use modeling and simulation tools to evaluate equivalence of generic drug
products. Use modeling and simulation to design and plan research studies that
involve bioequivalence evaluation. Examples of research areas include
absorption models for modified release oral products, physiologically based
PK/PD modeling and simulation for non-oral drug products, PK/PD modeling of
complex drug products, clinical trial simulation, and the use of modeling and
simulation in post-marketing safety surveillance.
Qualifications:
* Ph.D., M.D., Pharm.D., or other professional doctorate in PKPD, Clinical
Pharmacology, Pharmaceutical Sciences, Statistics, 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 more info please contact:
Xinyuan (Susie) Zhang, Ph.D.
DQMM/ORS/OGD/CDER/FDA
10903 New Hampshire Ave., Bldg. 75, Room 4612
Silver Spring, MD 20993
Phone: 240-402-7971
Email: Xinyuan.Zhang@xxxxxxxxxxx<mailto:Xinyuan.Zhang@xxxxxxxxxxx>
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