Associate Director, Radiology IND/IDE Support Office

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

📋 Description

• Oversee the daily functions of the Radiology IND/IDE Support Office

• Provide support and management for ongoing and upcoming departmental INDs and IDEs

• Supervise sponsor-investigator research activities related to investigational drugs and medical devices

• Collaborate with the FDA to ensure adherence to regulations, GCP, institutional policies, SOPs, and Trial Master File standards

• Create and execute risk-based monitoring plans for studies

• Evaluate protocols and case report forms to safeguard human subjects and guarantee data quality and regulatory adherence

• Conduct study-specific monitoring visits and complete monitoring reports under the direction of OCR Compliance

• Manage a team of fewer than 10 staff members who assist Department of Radiology investigators

• Guide and mentor regulatory staff, assign responsibilities, and ensure timely project completion

• Provide strategic leadership for FDA regulatory, safety reporting, and compliance efforts

• Maintain documentation that is ready for inspections and prepare research teams for audits and evaluations

• Facilitate collaboration across investigators and clinical research professionals

• Cultivate partnerships among clinical, regulatory, and operational teams to enhance research processes and reduce risks

⛳️ Requirements

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

• Preferred: 5–6 years of relevant experience along with a Master's degree

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

• Proven understanding of FDA regulations, guidance, and compliance standards in clinical research

• Familiarity with Good Clinical Practice (GCP)

• Knowledge in risk-based monitoring, regulatory affairs, clinical research operations, compliance, quality assurance, FDA regulations, data integrity, and strategic operations management

• Experience in leading and training staff

• Background checks may be necessary following a conditional job offer

• The position is dependent on grant funding

🏝️ Benefits

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

• Flexible spending accounts for qualifying health care and dependent care expenses using pre-tax dollars

• Tuition assistance for employees, their spouses, and dependent children at Penn, as well as eligible tuition support at other institutions

• Basic, matching, and supplemental retirement plans with options for pre-tax or Roth savings

• Investment opportunities available through TIAA and Vanguard

• Generous paid time off

• Long-term care insurance

• Wellness and work-life programs and resources

• Opportunities for professional and personal development

• Access to University libraries, athletic facilities, arboretum, art galleries, and various cultural and recreational activities

• Discounts and special services including those for arts and entertainment, transportation, mortgages, vehicles, cellular phone plans, movie tickets, and theme parks

• Flexible work options and hours

• Forgivable home loan for eligible employees purchasing or residing in West Philadelphia

• Adoption assistance for qualifying expenses for up to two adoptions per household