IND/IDE Program Director

4 weeks ago

Baltimore, Maryland, United States Johns Hopkins University Full time
Job Description

We are seeking a highly skilled IND/IDE Program Director to join our team at Johns Hopkins University. As a key member of our Office of Clinical Trials, you will be responsible for the overall implementation and management of our policy and program to support qualification and registration of JHU investigator-held INDs and IDEs in accordance with our governing guidelines.

Key Responsibilities
  • Develop and maintain all operational functions that support IND/IDE activities, including initial and ongoing qualification of JHU Investigators to serve as sponsor-investigators.
  • Evaluate the suitability of proposed JHU investigator-sponsors for specific IND/IDE applications prior to submission to the FDA.
  • Issue letters of suitability or identify potential areas of concern following initial evaluations.
  • Develop and maintain IND/IDE-related policies, procedures, guidelines, templates, tools, and databases.
  • Provide administrative support to the IND/IDE review committee and serve as a liaison between the Office of Clinical Trials and internal partners.
Requirements
  • Master's degree in a health-related science.
  • Minimum of 3 years of professional experience in a regulatory/compliance function at an academic, government, or pharmaceutical industry environment.
  • Direct experience with the application of IND/IDE regulations.
  • Experience and functional knowledge of FDA regulations related to clinical research involving human participants.
Preferred Qualifications
  • Regulatory Affairs and/or Clinical Research Professional Certification (RAC, CCRP/SOCRA).
  • Advanced Certificate in Clinical Trial Management.

This is an exciting opportunity to join a dynamic team and contribute to the advancement of clinical research at Johns Hopkins University. If you are a motivated and detail-oriented individual with a passion for regulatory compliance, we encourage you to apply for this role.

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