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 The Associate Director, Radiology IND/IDE Support Office leads the oversight of IND and IDE studies, with a strong emphasis on clinical research monitoring, risk-based monitoring, and regulatory compliance. This role directs the daily operations of the IND/IDE Support Office, serves as the primary FDA liaison, and oversees regulatory submissions, including IND/IDE applications, amendments, annual reports, safety reports, and associated FDA forms. The position is responsible for developing and implementing risk-based monitoring plans, overseeing monitoring visits/audits, reviewing source documentation and study data, identifying compliance risks, and ensuring timely implementation of corrective and preventive actions (CAPAs). The Associate Director ensures protocol compliance, subject safety, data integrity, and inspection readiness across all active and pending IND/IDE studies. Leads the preparation, review, and submission of FDA regulatory documents, including Forms FDA 1571 and 1572, IND and IDE applications, protocol amendments, annual reports, safety reports, and other required regulatory filings. Additionally, the Associate Director leads quality assurance and compliance initiatives, prepares research teams for FDA inspections and audits, and ensures adherence to FDA regulations, GCP, institutional policies, and SOPs. The role supervises regulatory and monitoring staff and collaborates closely with investigators, faculty, and institutional leadership to support efficient, compliant, and high-quality clinical research operations. Core Competencies: Clinical Research Monitoring, Risk-Based Monitoring, IND/IDE Regulatory Oversight, Research Compliance, Quality Assurance, Inspection Readiness, FDA Regulations, GCP, CAPA Management, Data Integrity, Clinical Research Operations, Staff Leadership, and Strategic Operations Management Job Description Job Responsibilities Key responsibilities include: 1.Oversight of regulatory support for investigational drugs and devices- Oversees FDA regulatory, safety, and compliance activities for IND/IDE studies. 2. Clinical Research Monitoring and Compliance- Leads monitoring oversight to ensure compliance, data integrity, and participant safety to FDA and institutional guidelines. 3. Leadership and Staff Management- Supervise Regulatory Staff (Team of <10 individuals) 4. Cross-Functional Collaboration- Lead Cross Functional Teams and serve as a subject matter expert, involving compliance and monitoring for the IND/IDE Radiology portfolio. Core Competencies: Clinical Research Monitoring, Risk-Based Monitoring, IND/IDE Regulatory Oversight (FDA form 1571 and FDA form 1572), Research Compliance, Quality Assurance, Inspection Readiness, FDA Regulations, GCP, CAPA Management, Data Integrity, Clinical Research Operations, Staff Leadership, and 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, monitoring, 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 - $110,000.00 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. To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay The Perelman School of Medicine’s mission is to advance knowledge and improve health through research, patient care, and the education. Our inclusive culture embraces diversity, fosters innovation, stimulates critical thinking, supports lifelong learning, and sustains our legacy of excellence. The University of Pennsylvania seeks talented faculty and staff for our vibrant community. Our institution is committed to diversity along dimensions of race, ethnicity, gender, sexual orientation, age, religion, disability, veteran status, interests, perspectives, and socioeconomic status. Grounded in equal opportunity, nondiscrimination, and affirmative action, Penn's robust commitment to diversity is fundamental to the University's mission of advancing knowledge, educating leaders for all sectors of society, and public service. The University of Pennsylvania prohibits unlawful discrimination based on race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

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

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