Perelman School of Medicine University of Pennsylvania

Communication: The Director serves as an authority for ACC investigators and research staff, which includes Investigational Drug Services (IDS) and other Penn Medicine ancillary departments, on matters related to regulatory submissions, facilitation, and essential document management.. As a key stakeholder, the Director represents the investigator/research team when working with internal regulatory groups such as the IRB, OCR, Clinical Trials Scientific Review and Monitoring Committee (CTSRMC), Data Safety and Monitoring Committee (DSMC), and DOCM, as well as external entities including pharmaceutical companies, contract research organizations, the FDA, and the NCI’s National Clinical Trials Network (NCTN) groups.. Knowledge of submission mechanisms to different IRBs (internal, local, commercial, central) and FDA centers (paper, email NextGen Portal, Electronic Submission Gateway (ESG. Knowledge and/or experience working with web-based e-regulatory document management systems such as eFlorence, Veeva Systems products, etc.. Choose from a wide variety of investment options through TIAA and Vanguard.

director of regulatory affairs

Description Job ResponsibilitiesThe Director manages all aspects of staffing, operations, systems, and expansion, with an emphasis on:Vision, Strategy, and Compliance: The Director is responsible for setting the vision and implementing the strategy for expanding regulatory support in a way that incorporates staff recruitment and retention strategies as well as portfolio management strategies. This involves anticipating and planning for changes in regulatory requirements and institutional policies governing clinical research as it relates to the functions of the department; understanding the scope of OCCR and strategically planning for the growth of department/division research activity; and liaising across the matrix, the University, and federal government as applicable. The Director ensures compliance with applicable regulations, institutional policies, and procedures and will work collaboratively with the ACC Department of Operations, Compliance, and Monitoring (DOCM) to implement risk mitigation strategies as needed. Collaboration: The Director develops and fosters close partnerships with internal and external leaders spanning departments, divisions, disciplines, and entities to implement the regulatory infrastructure established by the School of Medicine (SOM) and University (e.g., IRB procedures, reliance agreements, ancillary reviews, PSOM requirements for investigators, trainings, etc.). The Director facilitates collaborations between other departments, centers, researchers, and providers, and the supporting department, division, or entity. The Director establishes standard operating procedures, best practices, and new procedures within the department/division (in harmony with ACC, OCR, and institutional policies) while ensuring adherence to the requirements of internal and external regulatory bodies, and shares them collaboratively across the Cancer System (with opportunities for growth and improvement as discussed with the DOCM, University of Pennsylvania’s Institutional Review Board [IRB], the Office of Clinical Research [OCR], and other ancillary oversight committees).Communication: The Director serves as an authority for ACC investigators and research staff, which includes Investigational Drug Services (IDS) and other Penn Medicine ancillary departments, on matters related to regulatory submissions, facilitation, and essential document management. As a key stakeholder, the Director represents the investigator/research team when working with internal regulatory groups such as the IRB, OCR, Clinical Trials Scientific Review and Monitoring Committee (CTSRMC), Data Safety and Monitoring Committee (DSMC), and DOCM, as well as external entities including pharmaceutical companies, contract research organizations, the FDA, and the NCI’s National Clinical Trials Network (NCTN) groups.Innovation: The Director will identify improvement opportunities and lead improvement efforts, including technology solutions, and will work collaboratively in health system and school wide initiatives to advance regulatory frameworks and their associated processes and procedures. The Director will assist with the development of investigator-initiated trials (IITs), including multi-site/multi-entity IITs, and trials involving FDA Investigational New Drug (IND) applications, exemptions, and annual reports. The Director will assist in the development of a future sponsor support unit.Metrics and Evaluation: The Director will facilitate and track the flow of new research studies through the start-up process, identify obstacles to activation and propose improvements to the process. The Director will track, analyze, and report unit-wide characteristics to senior leadership as requested, including but not limited to an assessment of trial information, areas of potential risk or roadblocks to success, and corrective actions.The Director will have oversight of and responsibility for regulatory document submissions to the IRB, CTSRMC, FDA, and all applicable regulatory review committees, including new submissions, continuing reviews, amendments, adverse events, and reportable events. Under the direction of this position, the regulatory coordination teams will perform the day-to-day regulatory document management of clinical research studies, including IITs, single and multi-site IND trials, NCTN trials, and industry-sponsored trials. The Director is expected to understand the full complement of duties typically assigned to direct and indirect reports and to fully execute these tasks as needed to ensure consistent and smooth implementation of daily operational procedures.All work will be performed independently with minimal supervision or direction; some work-related responsibilities may occur outside of regular business hours. Work requires travel between offices and entities. Position is contingent upon continued funding.NOTE: This is a hybrid position splitting work between on-site and remote. Flexible work arrangements are available; however, qualified candidates are required to commute to meet job demands. Re-location and/or Visa Sponsorship is not available for this position.QualificationsMaster’s degree and 7–10 years relevant experience, or a combination of education and experience required. ACRP (or appropriate equivalent) and/or RAC certification required. Expert knowledge of regulations for the conduct of clinical research including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and Good Clinical Practice (GCP) required. Knowledge of submission mechanisms to different IRBs (internal, local, commercial, central) and FDA centers (paper, email NextGen Portal, Electronic Submission Gateway (ESG)) required. Oncology experience and oversight of regulatory portfolio including NCTN trials preferred.Intermediate/expert level of function in 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.Must have excellent problem-solving abilities, critical thinking skills, excellent communication skills, strong organizational and time management skills, strong leadership abilities, and a clear attitude of customer service. Must be able to work in a fast-paced environment with time sensitive deadlines and competing priorities. Candidates should welcome constructive criticism, be open to learning new approaches, and committed to continued career/professional growth. Ability to interpret regulations and laws, and disseminate information is required. Must be able to travel between clinical locations as needed.Job Location - City, StatePhiladelphia, PennsylvaniaDepartment / SchoolPerelman School of MedicinePay Range$110,850.00 - $190,000.00 Annual RateSalary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile. Affirmative Action Statement Penn adheres to a policy that prohibits discrimination on the basis of 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.Special Requirements Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.University BenefitsHealth, 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.​

START NEW SEARCH