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.

Job description:

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.

Job qualifications:

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 multitasking.

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.

Preferred characteristics:

  • 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 careers@reaganudall.org