The Department of Biomedical Informatics (DBMI) at Columbia University is looking to hire a Program Manager. The successful candidate will be responsible for the day-to-day operations for a recently awarded contract from the Food and Drug Administration. The candidate will work with Principal Investigator, Dr. George Hripcsak and his team. See the advertisement.
In 2017, the FDA’s Center for Biologics Evaluation and Research (CBER) launched the Biologics Effectiveness and Safety (BEST) initiative, an expansion of the CBER Sentinel System, to specifically address the unique characteristics of CBER-regulated biologic products (including vaccines, blood and blood products, tissues and advanced therapeutics). BEST is an active surveillance and evidence generation system that can support commitments of the Prescription Drug User Fee Act VI and 21st Century Cures Act of 2016. This contract will provide FDA with the support to serve in a convening role to 1) work collaboratively with FDA staff to plan, develop, coordinate, host and convene meetings and workshops, 2) conduct methods development activities, and 3) educate FDA staff and external stakeholders on the BEST infrastructure, capabilities and applications that serve FDA and stakeholder needs.
The currently available position is grant-funded.