Associate Director, ATC Cell Therapy Operations - West Region

Role Summary

The Associate Director, ATC Cell Therapy Operations will provide operational and clinical information on establishing lifileucel as the standard of care to physicians and other healthcare providers. They will lead the authorization activities of commercial centers and provide operational, quality, and clinical oversight post-launch, while developing relationships with Treatment Center staff across physicians, nursing, lab, pharmacy, and quality disciplines. The role requires experience in cellular therapy operations at a treatment center and the ability to work collaboratively with external teams and cross-functional internal partners.

Responsibilities

• Develop and maintain relationships with key stakeholders from the treatment center responsible for establishing the lifileucel service line (MD, PA, RN, MLT, CQA, etc.)
• Responsible for the operational oversight of 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 LIFILEUCEL
• Lead cross-functional meetings with the nursing, laboratory, pharmacists, quality, and operational champions to develop the product and patient workflows for LIFILEUCEL
• Clinical SME to develop or review operating Procedures (SOPs) required for Treatment Centers to order LIFILEUCEL
• Develop and prioritize solutions to problems post-launch, understand the relationship between actions and results, and be able to understand and appreciate the needs of the authorized treatment centers.
• Operational and Clinical Oversight of the tumor collection, final product receipt, storage and distribution, and LIFILEUCEL infusion system.
• 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 LIFILEUCEL center qualification process using risk-based tools for qualification, 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.
• Lead the training distribution to the assigned region.
• Contribute to training content development, review, and creation of education materials.
• Oversee logistics and manages changes for the regional accounts.
• 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.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Qualifications

• Advanced degree (master’s degree, NP, MHA, MPA, MBA) with certifications preferred (BMTCN, CPHQ, PM)
• 10+ years of progressive experience in a medical or pharmaceutical environment, including nursing, surgical oncology, and transplant/infusion centers preferred.
• Competence in 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.

Additional Requirements

• Must be able to travel up to 40%
• The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions.