Research Program Manager

2 days ago


Baltimore, Maryland, United States Johns Hopkins University Full time
About the Role

We are seeking a highly skilled and experienced individual to fill the position of IND/IDE Program Director at Johns Hopkins University. This is an exciting opportunity for someone who is passionate about regulatory compliance and wants to make a significant contribution to the success of our research programs.

The IND/IDE Program Director will be responsible for the overall implementation and management of the university's policy and program to support qualification and registration of JHU investigator-held INDs and IDEs in accordance with the JHU governing guideline.

The ideal candidate will have a strong background in regulatory affairs, clinical research, and project management, with a minimum of 3 years of experience in a similar role. They will be well-versed in FDA regulations related to clinical research involving human participants and possess excellent communication and interpersonal skills.

The IND/IDE Program Director will serve as the liaison between the Office of Clinical Trials and internal partners, including the IRB, Office of Policy Coordination, Clinical Trials Contracting Unit, Office of Research Administration, Departmental/Divisional leadership, and JHU/JHHS compliance monitoring programs. They will also provide guidance to JHU faculty serving sponsor-investigators and their research teams in the development of their submissions to the FDA.

In addition to their technical expertise, the IND/IDE Program Director must have excellent time management skills, including the ability to manage multiple and competing priorities, and be able to work effectively in a team environment.



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