Develop and maintain relationships with key stakeholders from the treatment center responsible for establishing the TIL service line.
Responsible for the operational oversight of authorized treatment centers in the assigned region.
Lead operational meetings with the physician leadership from Medical Oncology, Surgery, and Cell Therapy to establish a standard of care pathway for TIL.
Lead cross-functional meetings with the nursing, laboratory, pharmacists, quality, and operational champions to develop the product and patient workflows for TIL.
SME to develop or review operating Procedures (SOPs) required for Treatment Centers to order TIL.
Develop and prioritize solutions to operational barriers; understanding the needs of the authorized treatment centers.
Operational Oversight of the tumor tissue procurement workflow, final product receipt, storage and distribution, and TIL infusion.
Assess and approve any changes to the collection, courier tracking, order intake, and order processing systems to ensure the validated state of the systems is maintained.
Lead the TIL center authorization process using risk-based tools for authorization, training, monitoring, and disqualification.
Develop and execute training of authorized users. Ensure access to COI/COC is provided to trained individuals.
Oversee the Chain of Identity and Chain of Custody at the Treatment Center.
Respond to every detour from the established lifileucel standard of care pathway and commit to responding with the utmost experience and collegiality.
Support and/or own quality records (Deviations, CAPA, Change control, etc.).
Participate in advisory board meetings to gain insight into future educational needs.
Perform miscellaneous duties as assigned.
Requirements
Master’s degree in clinical field or healthcare administration with 7+ years of experience or Bachelor's degree with 9+ years of experience.
7+ years of progressive experience in a medical or pharmaceutical environment, including nursing, surgical oncology, and transplant/infusion centers preferred.
Competence in the following areas: Needs Assessment, Facilitation, Prioritization, Decision Making, Collaboration, Planning & Organizing, Implementation/Follow-up, Written and Verbal Communication.
Demonstrated ability to present compelling and influential oral presentations.
Management skills and operational capabilities.
Ability to perform under pressure and meet deadlines.
Ability to work effectively within a matrix organization to achieve desired outcomes.
Benefits
Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.