PRMS and Regulatory Affairs Director

Moffitt Cancer Center



Directs and oversees the regulatory infrastructure for Clinical Research at Moffitt. Responsible for the PRMS under the CCSG, which includes policy development, reporting and administrative leadership of associated communities. Responsible for long and short term planning and directing of regulatory activities. Negotiates with outside agencies (national and international) as needed to resolve key regulatory issues and expedite approvals of products and services. Represents Moffitt on local, regional, and national committees.

Ideal Candidate:
• Experience at an NCI designated cancer center with first-hand CCSG experience.
• Ability to organize, negotiate, and lead the team in strategic discussions with regulatory agencies.
• Be able to demonstrate strong leadership, interpersonal and communications skills (written and oral); performance tracking, mentoring, assessment, and discipline.
• Well-developed project management and problem solving skills.
• Demonstrates a thorough knowledge of federal regulations for clinical research trials.
• Must be able to address and navigate competing investigator, disease group, and institutional priorities in order to reach optimal solutions.

Responsibilities:
• Will provide long term strategic planning on clinical trials research and trial feasibility.
• Directs the development of policies and procedures for clinical trial research and assures appropriate approval from institutional compliance committees and funding agencies.
• Initiates and directs planning for protocol development. Prepares, reviews and maintains departmental reports on clinical research.
• In collaboration with other clinical research Managers/Directors, oversees the daily operations of the Regulatory and PRMS teams.
• Responsible for fiscal oversite of assigned cost centers.

Credentials and Qualifications:
• Bachelor’s degree; Master’s degree preferred.
• Minimum of seven (7) years of progressively responsible regulatory/quality management experience; specific oncology regulatory experience preferred.
• At least 5 years in management or senior regulatory role with demonstrated success in project management, interfacing with regulatory agencies, and strong budget management experience.

Please view our website at https://www.moffitt.org/careers-education/ requisition #24778.