Job Description:
• 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.