Job Location (Full Address):

601 Elmwood Ave, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

500295 Cancer Center SMH

Work Shift:

UR - Day (United States of America)

Range:

UR URCB 216

Compensation Range:

$84,557.00 - $118,380.00

Responsibilities:

Responsible for the administrative, operational, and financial oversight of commercially available gene- and cell-based therapies introduced for therapeutic use at URMC through the High-Cost Advanced Therapeutics (HCAT) Subcommittee process. Serves as the chair for both the HCAT Executive Steering and HCAT Operations Committees. Coordinates the cross-departmental assessment, implementation, and ongoing tracking of clinical, operational, and financial performance of HCAT-approved therapies. Collaborates with contacts in finance, contracting, department administration, legal, pharmacy, nursing, and medical ethics to ensure successful and financially sustainable FDA-approved gene- and cell-based therapy programs across all relevant clinical areas of the institution.

Essential Functions:

• Serves as the Chair for the HCAT Executive Steering Committee.Prepares quarterly reports summarizing all HCAT activity, including patient enrollment, clinical outcomes, costs, revenues, and new treatment entries approved (with associated business plan metrics).  Serves as the Chair for the HCAT Operations Committee to review all HCAT-related activities for new treatment approval, site qualifications, and patient qualifications.  Provides both clinical and financial tracking for all HCAT-related activities.  Coordinates the HCAT new treatment evaluation process, including assigning five parallel workgroups, ensuring progress towards submission of the product monograph, and organizing the final monograph for submission to relevant committees.  Provides monthly updates to relevant stakeholders concerning the status of new treatment evaluation and onboarding progress. Organizes and oversees the timely site qualification and approval process with manufacturers or their designated third parties. Coordinates any necessary subgroups across departments to ensure a smooth and timely site activation once site qualification is approved. Engages UR Communications/PR to develop internal and external communications strategies for HCAT-approved products.
• Develops a full business plan, including a 5-year proforma for treatments under review by the HCAT Subcommittee, in conjunction with finance, relevant department administrators, pharmacy supply chain, and others.Updates financial projections and overall business plans for HCAT-approved products as actual data becomes available, refining or revising initial projections. Works collaboratively with payer contracting to ensure terms and conditions of all payer contracts are aligned with URMC standards for HCAT-approved products. Ensures accurate, timely post-treatment tracking processes are in place to support financial performance at the individual patient and treatment levels. Maintains quarterly reporting on financial outcomes for all HCAT-approved products. In collaboration with Patient Financial Services, Payer Contracting, and Utilization Review, remains up to date on all coding, billing, and revenue projections for HCAT-approved products and those under consideration for use.
• Tracks patient activation process and serves as a liaison between clinicians, other departments, and patient/family, as needed.Ensures effective tools are in place to track patients across the qualification, approval, contracting, and activation/treatment phases of care. Ensures an accurate, timely post-treatment tracking process for clinical outcomes/metrics as specified in payer contracts, treatment protocols, or other industry standards. Ensures that all required training and education for HCAT-approved products are completed and documented before treatment is initiated. Ensures all REMS regulatory requirements, as indicated, are being met and documented to ensure full compliance and audit readiness. Facilitates and participates in cellular therapy quality committees and directs quality initiatives. Ensures all requirements, standards, and regulations related to cellular therapies are met, in collaboration with the BMT Quality Manager, to meet hospital and accreditation group quality initiatives and requirements.  Manages quality improvement opportunities, maintains data collection to meet program needs, and creates standardization for program development. Monitors the pipeline of cell- and gene-based therapies for therapeutics that may be relevant, through interactions with clinical leads, research teams, and manufacturers, as well as FDA approval decisions and proceedings from symposia and conferences. Serves as a liaison with manufacturers of cell- and gene-based therapies.
• Fosters effective communication with employees, peers, and leaders.Builds and maintains relationships with internal and external partners, as needed. Manages projects, teams, and work groups related to HCAT therapies. Establishes a service culture to provide a first-rate experience for customers (patients, referring providers, faculty). Ensures that staff across multiple departments receive job training and professional development in cell- and gene-based therapies. Manages the change process. Solves problems and makes effective decisions using data/input from stakeholders. Leads service improvement initiatives in the division. Ensures that senior leadership goals and the hospital's strategic plan are communicated to staff and physicians. Develops and maintains 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.
• Other duties as assigned.

Minimum Education & Experience:

• Master's degree in Nursing and 3 years of relevant experience in clinical practice required.
• Or equivalent combination of education and experience.
• 2 years of experience in business planning, administration, or fiscal and resource management preferred.

Knowledge, Skills & Abilities:

• Excellent project management skills, including collaborations across multiple departments preferred.
• Strong independent leadership skills preferred.

Licenses and Certifications:

• RN Licensure in NYS required upon hire.