RN, HCAT Administrator

Responsibilities

• Administrative, operational, and financial oversight of commercially available gene- and cell-based therapies.
• Serve as the chair for both the HCAT Executive Steering and HCAT Operations Committees.
• Coordinate cross-departmental assessment, implementation, and ongoing tracking of clinical, operational, and financial performance of HCAT-approved therapies.
• Collaborate with finance, contracting, department administration, legal, pharmacy, nursing, and medical ethics to ensure successful and financially sustainable FDA-approved gene- and cell-based therapy programs.
• Prepare quarterly reports summarizing all HCAT activity, including patient enrollment, clinical outcomes, costs, revenues, and new treatment entries approved.
• Review all HCAT-related activities for new treatment approval, site qualifications, and patient qualifications.
• Provide clinical and financial tracking for all HCAT-related activities.
• Organize and oversee the timely site qualification and approval process with manufacturers or their designated third parties.
• Engage UR Communications/PR to develop internal and external communications strategies for HCAT-approved products.
• Develop a full business plan, including a 5-year proforma for treatments under review by the HCAT Subcommittee.
• Update financial projections and overall business plans for HCAT-approved products as actual data becomes available.
• Collaborate with payer contracting to ensure terms and conditions of all payer contracts are aligned with URMC standards for HCAT-approved products.
• Maintain quarterly reporting on financial outcomes for all HCAT-approved products.
• Ensure accurate, timely post-treatment tracking processes are in place to support financial performance at the individual patient and treatment levels.
• Track patient activation process and serve as a liaison between clinicians, other departments, and patient/family, as needed.
• Ensure effective tools are in place to track patients across the qualification, approval, contracting, and activation/treatment phases of care.
• Ensure an accurate, timely post-treatment tracking process for clinical outcomes/metrics as specified in payer contracts, treatment protocols, or other industry standards.
• Ensure all required training and education for HCAT-approved products are completed and documented before treatment is initiated.
• Ensure all REMS regulatory requirements, as indicated, are being met and documented to ensure full compliance and audit readiness.
• Facilitate and participate in cellular therapy quality committees and direct quality initiatives.
• Ensure all requirements, standards, and regulations related to cellular therapies are met, in collaboration with the BMT Quality Manager.
• Manage quality improvement opportunities, maintain data collection to meet program needs, and create standardization for program development.
• Maintain interactions with clinical leads, research teams, and manufacturers, as well as FDA approval decisions and proceedings from symposia and conferences.
• Serve as a liaison with manufacturers of cell- and gene-based therapies.
• Foster effective communication with employees, peers, and leaders.
• Manage projects, teams, and work groups related to HCAT therapies.
• Establish a service culture to provide a first-rate experience for customers (patients, referring providers, faculty).
• Ensure that staff across multiple departments receive job training and professional development in cell- and gene-based therapies.
• Manage the change process.
• Solve problems and make effective decisions using data/input from stakeholders.
• Lead service improvement initiatives in the division.
• Ensure that senior leadership goals and the hospital's strategic plan are communicated to staff and physicians.
• Develop and maintain knowledge and competence related to cell- and gene-based therapies through continuing education, conferences, primary literature, liaison activities with peers, peer organizations, and manufacturers, and any other means necessary.

Qualifications

• Master's degree in Nursing and 3 years of relevant experience in clinical practice required.
• Equivalent combination of education and experience may be considered.
• 2 years of experience in business planning, administration, or fiscal and resource management preferred.
• Excellent project management skills, including collaborations across multiple departments preferred.
• Strong independent leadership skills preferred.