Research Program Manager
The Reagan-Udall Foundation for the FDA (the Foundation) is a non-profit organization that works to support the mission of the FDA by advancing regulatory science and research. The Foundation is seeking a mission-driven Research Program Manager with an interest in joining a small and growing team and a willingness to stretch and take on additional tasks as needed.
The Research Program Manager (RPM) will provide professional leadership for activities associated with the development and management of research partnerships in pharmacoepidemiology. The PM will manage a variety of projects and facilitate the creation of a portfolio of pharmacoepiemiology studies conducted and funded by external research partners. The RPM 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 pharmacoepi-‐ related projects. The research portfolio includes large scale collaborative observational and/or clinical trials, along with studies designed to develop and meet regulatory requirements for post-market surveillance of regulated products. Minimal travel may be required for this position.
The RPM may also supervise the activities of one or more Project Managers, Associates and/or interns to ensure that individual research projects in the portfolio are conducted in a timely and effective manner, and within budgetary constraints. The RPM will report to the Director of Research.
The RPM should be intellectually flexible and comfortable working with funding and research partners in technical areas s/he does not consider to be his/her primary area of expertise. The RPM should be detail-‐oriented, proactive, organized, and adept at multi-‐tasking.
The RPM should have a demonstrated ability to:
- Manage a diverse portfolio of research projects, from conception and negotiation with sponsors to management of vendors and other partners.
- Continuously monitor progress towards project milestones, including recommending and implementing modifications to effectively meet project milestones.
- Facilitate internal and external project team meetings, tracking action items, and following up to ensure action items are being completed.
- Understand scientific data management processes, intellectual property rights, and publication processes and procedures.
- Take appropriate planning measures to develop, execute, and manage grants and contracts.
- Develop and manage budgets.
- Five (5) years of program management experience, preferably in a scientific field.
- Experience working with “big data” from healthcare settings.
- An understanding of pharmacoepidemiology or outcomes research (clinical/epidemiological research background preferred).
- A familiarity with FDA regulations for post-authorization studies (primarily) and drug or biological product development (secondary).
- A graduate degree in a relevant field.
Key words: Program management; research administration; public-‐private partnership; pharmacoepidemiology; real-world data
To apply: Email your cover letter, resume, three references and your salary requirements to email@example.com