Director, Regulatory Oversight

The Edge Group
Posted Feb 02
Full Time
Baltimore, Maryland

Director, Regulatory Oversight – HRPP & IACUC Baltimore, MD area Our client, a prestigious research institution, is seeking a Director of Regulatory Oversight. This role is responsible for leading the administrative, regulatory, and programmatic activities supporting the health care system’s Human Research Protection Program (HRPP), animal care and use program (IACUC), and oversight committees for the use of recombinant DNA and biohazardous materials, as well as research involving human embryonic and/or pluripotent stem cells. This Director is also responsible for administrative oversight of the research radiation and laser safety programs, working closely with the Office of Research Integrity and Compliance leadership, the Office of Clinical Research (OCR) staff, Environmental Health and Safety, Office of General Counsel, regulatory committee Chairs and members, the Attending Veterinarian, and others in the systems research community to ensure operational efficiency and compliance with laws, regulations, standards, and institutional requirements that impact the research enterprise. Position responsibilities include:

  • Providing strategic leadership and operational direction to the Office of Human Research (OHR) and Office of Research Safety (ORS)
  • Overseeing the administrative, regulatory, and programmatic activities of the Institutional Review Boards (IRB); Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC), Stem Cell Research Oversight Committee (SCRO), and Laser safety program.
  • Serving as Human Protections Administrator (HPA) on systems Federal Wide Assurance (FWA)
  • Facilitating maintenance of AAALAC accreditation; supporting and overseeing AAHRPP accreditation.
  • Directing semi-annual facility inspections and program reviews.
  • Coordinating with Environmental Health and Safety to manage oversight of the EHS Research Specialist, and EHS/occupational health-related matters for the research program.
  • Providing expert regulatory guidance to researchers, staff, committee members, and leadership and partners internal and external to the organization. Serves as liaison between researchers & research teams, department management, committees & leadership related to areas of expertise.
  • Collaborating with the Executive Director for Research Integrity and Compliance, to develop, deliver, and maintain education and outreach programming for the committees and the research community in areas of oversight to ensure compliance.
  • Overseeing administrative management of protocols, ensuring staff alignment with requisite expertise, ensuring appropriate staff coverage for regulatory operations.

Minimum qualifications:

  • Bachelor’s degree in an appropriate area of specialization and 8 years of relevant professional experience, OR a master’s degree or higher in a relevant area of study plus 6 years of relevant professional experience. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training, and experience.
  • Experience with and thorough knowledge of federal regulations and guidelines related to the oversight of laboratory animal research and use of biohazardous materials in research
  • CIP CPIA credentialed or qualified to earn the designation within one year of employment
  • Ability to maintain the confidentiality of sensitive information
  • Understanding of molecular and biochemical standard methods and cell culture in an academic research laboratory
  • Operational managerial experience is highly desirable