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

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes 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, and much more.

Posted Job Title

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

Job Profile Title

Associate Director D, Research

Job Description Summary

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.

Job Description

Job 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.

  Key responsibilities include:

• 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.

• Core Competencies: Risk-Based Monitoring, Regulatory Affairs, IND/IDE Studies, Clinical Research Operations, Research Compliance, Quality Assurance, Staff Leadership and Training, FDA Regulations, GCP, Data Quality, Strategic Operations Management.

• Position is contingent upon grant funding

Qualifications

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

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$80,891.00 - $80,891.00 Annual Rate

Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement 

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements 
Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

• Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.

• Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.

• Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.

• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.

• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.

• Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.

• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.

• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.

• Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.

• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.

• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.

• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.

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To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay