FDA fellowship

Office of Clinical Pharmacology 2018-2019 Policy Fellowship The Office of Clinical Pharmacology (OCP) at the U.S. Food and Drug Administration (FDA) is seeking interested individuals for a one-year ORISE (Oak Ridge Institute for Science and Education) fellowship to conduct OCP and FDA policy evaluations that will advance new drug development and promote therapeutic individualization. Potential project topics are diverse and will be instrumental in the development of both scientific and regulatory guidelines and policies. Possible project topics could include: · Clinical pharmacology considerations for leveraging real-world evidence · Lifecycle evaluation of drug interaction policy · Programmatic evaluation of clinical pharmacology-informed regulatory decisions (e.g., citizen’s petitions, stakeholder engagement, regulatory milestone communications, etc.) For more information about FDA ORISE fellowships, please visit https://orise.orau.gov/fda/. At FDA, OCP is housed within the Center for Drug Evaluation and Research (CDER) and is a dynamic organization with a mission to improve public health by enabling patient-centered regulatory decisions of the highest quality. For more information about OCP, please visit OCP's https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm106189.htm. The OCP fellowship will include three components: 1) OCP and FDA policy evaluations mentioned above, 2) self-guided didactic training through the FDA scientific and professional courses, and 3) additional projects and activities for fellow-specific professional development. Fellowship mentoring will also be determined by the fellow’s style and professional interests. Prospective fellows should have an advanced degree in a STEM or health-related field (e.g., MS, PhD, PharmD, and/or MD). The candidate should possess excellent analytical, written, and oral communication skills, and have a profound interest in leading projects that advance regulatory science and public health. To apply or request more information, please email the following to [email protected]<mailto:[email protected]> no later than April 30, 2018: · A short introductory paragraph (4-8 sentences) · Current CV