The Reagan-Udall Foundation for the FDA (the FDA Foundation) is a non-profit organization that works to support the mission of the FDA by advancing regulatory science and research. The Foundation establishes public-private partnerships between FDA and external stakeholders to facilitate innovation in science and health. Learn more at www.reaganudall.org.
The Research Manager (RM) will manage research activities associated with the development and management of research partnerships in epidemiology, clinical trials, and/or biomedical and behavioral research. The RM will manage sponsored research projects and support proposal development of epidemiologic studies funded by sponsors and conducted by external research partners. The RM will work with leading experts from government agencies (including NIH and FDA), industry, non-profit organizations, and academia to design, promote, fund and monitor the progress of biomedical and/or behavioral research projects. The research portfolio includes the development of workshops to advance research methods to generate real-world evidence and patient-centered study designs for both observational and clinical trials, along with studies designed to develop and meet regulatory requirements for post-market surveillance of regulated products.
The RM may also direct the efforts of one or more staff to ensure that individual research projects in the portfolio are conducted in a timely and effective manner, and within budgetary constraints. The RM will report to the Director of Research.
The RM should be intellectually and scientifically flexible to work with funding and research partners in technical areas s/he does not consider to be his/her primary area of expertise. The RM should be a detail-oriented, proactive, and organized self-starter adept at managing multiple research projects. The successful candidate will also possess excellent writing and critical thinking skills.
The RM should have a demonstrated ability to:
- Lead and facilitate multi-‐disciplinary, public/private sector teams.
- Manage a diverse portfolio of research projects.
- Understand issues related to research administration, including scientific journal submission process, IRB, data privacy and security, intellectual property rights, etc.
The RM should have:
- An understanding of epidemiology or health outcomes research (clinical/epidemiological research background preferred).
- A graduate degree in a relevant field (doctoral degree preferred).
- Experience in investigator-led research activities, either as a principal investigator or co-investigator.
- Experience working with big data from healthcare settings.
Temporary Position: Approx. January 1, 2022-March 31, 2022
Duty location: Fully Remote
Tour of Duty: 20 to 40 hours per week
Travel requirements: None
To apply: Email your cover letter, resume, two references and your salary requirements to firstname.lastname@example.org