Associate Director, Regulatory

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

Associate Director, Regulatory

Job Profile Title

Associate Director, Clinical Research Regulatory

Job Description Summary

With the oversight of the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of clinical research undertaken within the department/division. The Associate Director for Regulatory Affairs assists the Director in providing direction and strategic planning for clinical research regulatory operations including overseeing the activities of a Regulatory Office (or Regulatory Program)/reporting regulatory affairs staff, anticipating and planning for changes in the regulations governing clinical research, planning for the regulatory aspects of growth of department/division research activity, and liaising with regulatory groups across the department/division, University, and federal government.

Job Description

Job Responsibilities

• With the oversight of the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of clinical research undertaken within the department/division. The Associate Director for Regulatory Affairs assists the Director in providing direction and strategic planning for clinical research regulatory operations including overseeing the activities of a Regulatory Office (or Regulatory Program)/reporting regulatory affairs staff, anticipating and planning for changes in the regulations governing clinical research, planning for the regulatory aspects of growth of department/division research activity, and liaising with regulatory groups across the department/division, University, and federal government.

• The Associate Director for Regulatory Affairs will directly oversee, train and mentor any reporting Regulatory Affairs Supervisor and/or Regulatory Affairs Specialist A/B/C. In this capacity, the Associate Director for Regulatory Affairs will have oversight of all regulatory staff, including monitoring workload intensity and tracking deadlines to ensure timely and appropriate regulatory reporting and compliance for any/all clinical research conducted within the department/division. The Associate Director for Regulatory Affairs will assist the Director in establishing and maintaining Standard Operating Procedures for the Regulatory Office (or Regulatory Program) to ensure adherence to regulatory requirements of the University of Pennsylvania and all applicable regulatory bodies. In conjunction with any reporting Regulatory Affairs Supervisor, the Associate Director for Regulatory Affairs will evaluate regulatory staff performance and identify areas for improvement.

• The Associate Director for Regulatory Affairs will serve as the primary point of authority for the Physician-Investigators and clinical research staff on regulatory affairs matters. The Associate Director for Regulatory Affairs will contribute to/assist in the development of training programs for investigators to enhance understand of and compliance with applicable regulations.

• The Associate Director for Regulatory Affairs will also serve as the key departmental stakeholder representing the department/division when working with internal regulatory groups including the University of Pennsylvania’s Institutional Review Board (IRB), the Office of Clinical Research (OCR), and any other ancillary oversight groups; as well as for external entities including pharmaceutical companies, contract research organizations (CROs), the FDA, and research networks such as the National Cancer Institute Cooperative/Clinical Network Groups in the conduct of clinical trials. They will oversee preparations for and serve as a key departmental stakeholder representing the department/division related to regulatory audits by the FDA, EMA, other Competent Health Authorities and other University Departments.They will assist with the development of investigator-initiated research protocols and development/maintenance of study specific case report forms and source document tools. They will facilitate collaborations in the conduct of clinical trials between other departments, centers, researchers and the supporting department/division, including but not limited to the development of best practices and new policy within the department/division and to be shared collaboratively across the University(opportunities for growth and improvement as discussed with the University of Pennsylvania’s Institutional Review Board (IRB), the Office of Clinical Research (OCR) and other ancillary oversight committees).

• The Associate Director for Regulatory Affairs will work collaboratively with research teams to identify resource requirements for upcoming protocols, forecast logistical issues impacting regulatory compliance, and ensure smooth transition of protocols from regulatory start up to study activation. They will assist the Director with facilitating and tracking the flow of new research studies through the start-up process, by identifying regulatory obstacles to activation, and propose improvements to the process will track, analyze and report to senior leadership department-wide trial characteristics, accrual information and audit/monitoring findings; such reports will include an assessment of trial information, areas of potential risk or roadblocks to success, and potential corrective actions. The Associate Director for Regulatory Affairs will facilitate ongoing improvement of clinical trial compliance and quality assurance through communication of audit results and compliance guidelines.

• The Associate Director for Regulatory Affairs will have oversight of regulatory submissions to the IRB and all applicable regulatory review committees across the portfolio of research undertaken by the department/division. Regulatory applications may include new study submissions, continuing reviews, amendments, adverse events, and reportable events. They will oversee the organization and maintenance of all regulatory affairs documentation/investigator site files (ISF) as required by regulation across the department/division, including anticipating for and implementing updates to document storage/retention/destruction policies and programs. They will provide leadership to resolve regulatory and data queries through close collaboration with auditors, involved business units, investigators, research teams, and research partners. This may include developing and fostering close partnerships with both internal and external leaders spanning departments, divisions, and disciplines. They will attend initiation, monitoring, audit and close-out study visits as needed in support of department/division staff, goals, and/or to discussion opportunities and growth. They will attend study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings in a leadership capacity.

• Other duties as assigned.

Qualifications

• · Bachelor’s degree and 7-10 years relevant experience, or a combination of education and experience required. Master’s degree preferred. ACRP and/or RAC certification required. Expert knowledge of GCP, and relevant regulations for the conduct of clinical research including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and Good Clinical (Research) Practice (GCP) Guidelines required. Knowledge of appropriate submission mechanisms to different FDA centers (paper, email NextGen Portal, Electronic Submission Gateway (ESG)) required. Demonstrated project and time management skills are necessary; must be able to work independently with minimal supervision. Outstanding organizational skills and the ability to function in a team environment are required.

• The successful candidate must also have effective problem solving and critical thinking abilities; effective communication and writing skills; be flexible and able to multi-task. Prior education or experience with IND/IDE/Expanded Access Applications, drug development process, medical writing, and clinical trial operations required.

• Qualified candidates must also demonstrate excellent written and verbal communication skills; advanced computer software skills; a clear attitude of customer service; must be able to work in a fast-paced environment with time sensitive deadlines and competing priorities; the ideal candidate will have very strong analytical and critical thinking skills, and the ability to build and maintain positive working relationships at all levels of the institution. Candidates should desire to mentor/foster the growth of peers and have experience training peers in a research setting. Candidates should welcome constructive criticism, be open to learning new approaches, and committed to continued career/professional growth. Intermediate/expert level of function in all of the Microsoft Office applications, as well as, applications for team interconnectivity such as Slack, Microsoft Teams, Zoom, Webex, etc. Knowledge and/or experience working with web-based e-regulatory document management systems such as eFlorence, Veeva Systems products, etc. is a plus.

• Candidate must have a solid understanding and ability to apply, as well as teach, all skills outlined in the junior level roles

• Resume and cover letter required with application

Job Location - City, State

Philadelphia, Pennsylvania

Hybrid Eligible - This position is eligible for a hybrid work schedule with a work week divided between working onsite and working remotely.

Department / School

Perelman School of Medicine

Pay Range

$105,500.00 - $130,000.00 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.

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The University of Pennsylvania’s special character is reflected in the wide variety of backgrounds, experiences, and perspectives of the Penn community. We seek talented faculty and staff who will constitute a vibrant community and help create an educational and working environment that best supports the University’s commitment to excellence in teaching, research, and scholarship. 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.