Associate Director, Radiology IND/IDE Support

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Direct the everyday functions of the Radiology IND/IDE Support Office.

• Assist in managing both active and pending domestic and international INDs and IDEs.

• Supervise research operations related to investigational drugs and medical devices under the auspices of the Department of Radiology.

• Coordinate with the FDA to ensure adherence to regulations, Good Clinical Practice (GCP), institutional policies, Standard Operating Procedures (SOPs), and SOP requirements.

• Maintain accurate Trial Master Files.

• Create and implement risk-based study monitoring strategies.

• Assess protocols and case report forms.

• Conduct study-specific monitoring visits and finalize monitoring reports in alignment with OCR Compliance directives.

• Oversee a small team of fewer than 10 staff members assisting departmental investigators.

• Guide and mentor regulatory staff, allocate responsibilities, and guarantee timely execution of deliverables.

• Provide strategic oversight for FDA regulatory compliance, safety reporting, and related activities.

• Ensure documentation is inspection-ready and prepare research teams for audits and inspections.

• Facilitate cross-functional collaboration among investigators and clinical research professionals.

• Foster partnerships across clinical, regulatory, and operational teams to enhance research efficiency and reduce risk.

⛳️ Requirements

• A Bachelor's degree in a scientific or related field (B.S. or B.A.) along with 7–10 years of monitoring experience, or an equivalent combination of education and experience.

• Preferred: 5–6 years of relevant experience and a Master's degree.

• Experience in supporting FDA-regulated clinical research, including IND and/or IDE studies.

• Proven knowledge of FDA regulations, guidelines, and compliance requirements relevant to clinical research.

• Familiarity with risk-based monitoring, regulatory affairs, clinical research operations, research compliance, quality assurance, FDA regulations, GCP, data quality, and strategic operations management.

• This position is contingent upon grant funding.

• Background checks may be necessary following a conditional job offer.

🏝️ Benefits

• Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance coverage.

• Flexible spending accounts for qualified health care and dependent care expenditures.

• Tuition assistance available for employees, spouses, and dependent children.

• Tuition assistance for dependent children attending other institutions.

• Basic, matching, and supplemental retirement plans.

• Pre-tax or Roth retirement savings options.

• Investment opportunities through TIAA and Vanguard.

• Generous paid time off.

• Long-term care insurance.

• Wellness and work-life programs and resources.

• Professional and personal development opportunities.

• Access to university libraries, athletic facilities, arboretum, art galleries, and cultural and recreational activities.

• Discounts and special services for arts, entertainment, transportation, mortgages, vehicles, cellular services, movie tickets, and theme parks.

• Flexible work arrangements and hours.

• Forgivable loan available through Penn Home Ownership Services for eligible employees.

• Adoption assistance for qualifying expenses, covering up to two adoptions within the household.