Duties: Reporting to the Associate Dean for Clinical Research, the Executive Director/Director will lead the Office of Clinical Research, comprising the following units: Research Compliance and Clinical Research Support. Responsible for realizing the strategic goals for human research for the Perelman School of Medicine from project inception to reality. Must understand the missions of an academic health center and have conducted human-subject research; responsible for oversight of pre-award planning of clinical trials (protocol development, CRF design, IND/IDE/501K submission, COI etc); development and implementation of training programs; monitoring regulatory compliance; fostering relationships with industry, clinical research organizations, and other academic institutions; liaison with the FDA, OHRP, OCR and NIH; problem resolution; and business development. Primary PSOM liaison with University for issues relating to human-subject research. Responsible for training investigators and support staff; responsible for development and maintenance of standard operating policies and procedures for clinical research.
Qualifications: Education and experience equivalent to a Medical, Doctoral or other advanced professional degree and a minimum of 4 years in the clinical research operations/regulatory affairs, including:
-progressive clinical research experience, including oversight or direct responsibility for the design, planning, conduct, and management of clinical trials from first-in-human through regulatory submission.
-progressive regulatory affairs experience in the industry or national regulatory authorities.
-recruiting, hiring, supervising, training, and developing and mentoring staff..
Education, training, and/or demonstrated knowledge of HHS regulations, Good Clinical Practice (GCP) and IND/IDE and regulations/ guidelines/guidance/processes of relevant regulatory authorities are required. Knowledge of Good Laboratory Practices and Good Manufacturing Practices a plus.
- Proficiency in supervising and managing performance, and developing and mentoring individuals.
- Excellent communication, problem solving, decision-making and negotiation skills.
- Ability to lead cross-functional operations, education, and regulatory teams and to listen, motivate, lead, and facilitate issue resolution in such an academic research environment.
- Proactive identification of project-related and cross-functional issues and recommendation of adequate strategies and solutions.
- Application of knowledge and analytical skills in a highly regulated environment
- Demonstrated commitment to respect and protect highly sensitive and confidential information.
- Ability to effectively build relationships and work with diverse constituents and authorities.
Reference Number: 40-17480
Salary Grade: 031
Employment Type: Exempt
Org: SM-DN-Office of Human Participant Research
Special Requirements: Background Check Required
Job Family: B-Executive/Managerial Administration