Role Title: Associate Director, Radiology IND/IDE Support Office

Perelman School of Medicine at the University of Pennsylvania

88d•Onsite

About The Position

Leads the daily operations of the Radiology IND/IDE Support Office, supporting active and pending domestic and international INDs and IDEs. Oversees sponsor-investigator research involving investigational drugs and medical devices, serving as the liaison with the FDA to ensure compliance with regulatory requirements, GCP, institutional policies, SOPs, and Trial Master File maintenance. Directs risk-based monitoring activities, protocol and CRF review, and study monitoring to ensure subject protection, data integrity, and regulatory compliance. Manages a team of fewer than 10 staff supporting departmental investigators and collaborates extensively with faculty, researchers, and senior leadership across Radiology, the Perelman School of Medicine, and the Office of Clinical Research.

Requirements

Bachelor's degree in a scientific or related discipline (B.S. or B.A.) and 7-10 years of experience as a monitor or an equivalent combination of education and experience required.
Experience supporting FDA-regulated clinical research, including IND (Investigational New Drug) and/or IDE (Investigational Device Exemption) studies.
Demonstrated knowledge of FDA regulations, guidance, and compliance requirements applicable to clinical research.

Nice To Haves

5-6 years of relevant experience and a Master's degree preferred.

Responsibilities

Responsible for leading the daily operations of the Radiology IND/IDE Support Office, which supports and oversees several active and pending INDs and IDEs within the department.
Oversees research operations involving investigational drugs and medical devices where the Department of Radiology is the sponsor, acting as a liaison between the department and the FDA to ensure compliance with FDA regulations, institutional policies, Good Clinical Practice (GCP), institutional standard operating procedures, and the maintenance of appropriate Trial Master Files.
Responsible for the development and implementation of risk-based study monitoring plans, review of protocols and case report forms to ensure the rights and well-being of human subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents, and the study is compliant with the currently approved protocol, GCP, and all applicable regulatory requirements.
Will also be responsible for the timely execution of study-specific monitoring visits and completion of monitoring reports under the direction of OCR Compliance.
Manages a staff of <10 people who handle day-to-day operations of the IND/IDE Support Office for the Department of Radiology, supporting departmental study investigators.
Interacts with multiple other staff and investigators/faculty conducting department-based IND/IDE research.
Interacts with high-level staff and administrators in the Department of Radiology, the Perelman School of Medicine, and the Office of Clinical Research.
Development and implementation of risk-based monitoring study monitoring plans, review of protocols and case report forms, and the timely execution of study-specific monitoring visits and completion of monitoring reports under the direction of OCR Compliance.
Supervise and mentor regulatory staff by overseeing regulatory and compliance activities, delegating responsibilities, and ensuring timely completion of deliverables in accordance with applicable regulatory requirements while maintaining appropriate Trial Master Files
Provide strategic oversight of FDA regulatory, safety reporting, and compliance activities for departmental investigator-initiated studies, ensuring inspection readiness across the research portfolio for departmental INDs and IDEs.
Supervise and mentor regulatory staff by overseeing regulatory and compliance activities, delegating responsibilities, and ensuring timely completion of deliverables in accordance with applicable regulatory requirements
Lead cross-functional collaboration among departmental investigators and clinical research professionals to support departmental IND/IDE investigators and efficient clinical research operations.
Lead inspection readiness initiatives by maintaining audit-ready documentation, preparing research teams for inspections and audits, and ensuring compliance with FDA regulations, Good Clinical Practice (GCP), and institutional policies.
Build and maintain collaborative partnerships across clinical, regulatory, and operational teams to streamline research processes, proactively mitigate risk, and support successful study execution and compliance objectives.

Benefits

Excellent healthcare and tuition benefits for employees and their families
Generous retirement benefits
A wide variety of professional development opportunities
Supportive work and family benefits
A wealth of health and wellness programs and resources
Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
Flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars
Tuition assistance for employees, their spouse, and dependent children
Tuition assistance for dependent children at other institutions
Generous retirement plans
Pre-tax or Roth basis retirement savings
Wide variety of investment options through TIAA and Vanguard
Substantial amount of time away from work
Long-term care insurance
Wellness and Work-life Resources
Professional and Personal Development resources
Access to a wide range of University resources as well as cultural and recreational activities
Discounts and special services
Flexible work options
Forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia
Adoption Assistance