Associate Director, Radiology IND/IDE Regulatory Lead

University of Pennsylvania; Pennsylvania; On-site; USD 73,000 - 89,000; Full time

Benefits offered by this job

Health benefits

Tuition benefits

Retirement plans

Wellness programs

Job summary

The University of Pennsylvania is seeking an Associate Director for the Radiology IND/IDE Support Office in Philadelphia to oversee daily operations, ensure regulatory compliance, and liaise with the FDA on IND/IDE activities.

The role requires leadership of a small regulatory team and development of risk-based monitoring plans, partnering with Radiology, Perelman School of Medicine, and OCR to protect subjects and ensure data integrity.

Qualifications

• Bachelor’s degree in a scientific or related discipline and 7-10 years of experience as a monitor or equivalent.
• Master’s degree preferred.
• Experience supporting FDA-regulated clinical research, including IND and/or IDE studies.
• Demonstrated knowledge of FDA regulations, guidance, and compliance requirements applicable to clinical research.

Responsibilities

• Lead the daily operations of the Radiology IND/IDE Support Office, supporting INDs/IDEs and liaising with the FDA.
• Develop and implement risk-based study monitoring plans and review protocols to protect human subjects.
• Execute monitoring visits and prepare monitoring reports under OCR Compliance; manage staff of <10 people.
• Provide strategic oversight of FDA regulatory, safety reporting, and compliance activities for investigator-initiated studies.
• Lead cross-functional collaboration with investigators and clinical research professionals.
• Ensure inspection readiness and maintain audit-ready documentation.

Skills

Regulatory Affairs

FDA Regulations

Clinical Research Operations

Risk-Based Monitoring

Staff Leadership

GCP

Education

Bachelor’s degree in a scientific or related discipline

Master’s degree preferred

Job description

The University of Pennsylvania is seeking an Associate Director for the Radiology IND/IDE Support Office in Philadelphia to oversee daily operations, ensure regulatory compliance, and liaise with the FDA on IND/IDE activities.

The role requires leadership of a small regulatory team and development of risk-based monitoring plans, partnering with Radiology, Perelman School of Medicine, and OCR to protect subjects and ensure data integrity.