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FDA Model-Informed Drug Development Approaches for Evaluation of Therapeutic Proteins and Peptides

*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available in the Office of Tissues and Advanced Therapies (OTAT), at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
This project will develop and facilitate the application of model-informed drug development (MIDD) tools for the elucidation of pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of therapeutic products. Under the guidance of a mentor, the selected participant will leverage multiple data sources and contribute to the development of quantitative models by incorporation of mechanistic knowledge, developmental maturation and unique features of macromolecules across the pediatric age groups. 
Through this research opportunity, the selected participant will have the opportunity to learn and apply computational modeling skills, including PK/PD modeling, physiologically-based pharmacokinetic modeling and quantitative system pharmacology modeling, to address public health-related issues and gain experience in developing tools geared towards the advancement of regulatory science. During the project, the participant will be actively encouraged to present the research at internal and external meetings and publish the findings in peer-reviewed journals. The training will be useful for individuals seeking careers in both academia and industry.

Qualifications
The qualified candidate should be currently pursuing or have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
Preferred skills:
  • Analytical skills
  • Experience in modeling and simulation software (e.g. R, Matlab, NONMEM, etc.)
This opportunity is available to US citizens and Lawful Permanent Residents (LPR) only.
If you have questions, send an email to ORISE.FDA.CBER@orau.org. Please include the reference code for this opportunity (FDA-CBER-2020-0015) in your email.