Associate Director, Regulatory

Associate Director, Regulatory

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 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