Radiology IND/IDE Program Lead

Opportunity for Health; Philadelphia (Philadelphia County); Hybrid; USD 73,000 - 89,000; Full time

Benefits offered by this job

Health benefits

Tuition benefits

Retirement plans

Wellness programs

Job summary

University of Pennsylvania seeks an Associate Director to lead the Radiology IND/IDE Support Office, coordinating regulatory compliance for INDs and IDEs. You will manage monitoring activities, ensure data integrity, and supervise a regulatory team within the Radiology department.

Role involves liaising with the FDA, maintaining trial master files, and ensuring GCP and institutional policies across multiple projects in the Perelman School of Medicine.

Qualifications

• Bachelor's degree in a scientific or related discipline required with 7–10 years of monitor or equivalent experience.
• 5–6 years of relevant experience and a 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 daily operations of the Radiology IND/IDE Support Office, overseeing INDs/IDEs and liaising with the FDA to ensure regulatory compliance.
• Develop and implement risk-based monitoring plans; review protocols and case report forms; ensure subject protection and data integrity.
• Supervise regulatory staff, delegate responsibilities, and ensure timely deliverables with proper Trial Master Files.
• Provide strategic oversight of regulatory, safety reporting, and compliance activities across investigator-initiated studies.

Skills

Regulatory affairs

IND/IDE studies

Clinical research operations

FDA regulations

GCP compliance

Education

Bachelor's degree in science or related discipline

Master's degree preferred

Job description

University of Pennsylvania seeks an Associate Director to lead the Radiology IND/IDE Support Office, coordinating regulatory compliance for INDs and IDEs. You will manage monitoring activities, ensure data integrity, and supervise a regulatory team within the Radiology department.

Role involves liaising with the FDA, maintaining trial master files, and ensuring GCP and institutional policies across multiple projects in the Perelman School of Medicine.