Associate ATC Operations Liaison

Iovance Biotherapeutics

18d•Remote

About The Position

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. Overview The Associate ATC Operations Liaison will provide operational and clinical information on establishing TIL as the standard of care to physicians and other healthcare providers. The Associate ATC Operations Liaison will lead the authorization activities of commercial centers and provide operational, quality, and clinical oversite post-launch. The Associate ATC Operations Liaison will also identify and develop relationships with Treatment Center’s physicians, nursing, lab, pharmacy, and quality personnel. The successful candidate will have experience working in the cellular therapy field at a treatment center by working within operations, quality, the cell lab, or nursing and bringing practical knowledge and skills as they interact with external teams (physicians, surgeons, nurses, administrators, quality personnel) and work collaboratively with cross-functional internal teams. Understanding the environment and influences impacting the treatment centers’ providers and personnel.

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.
Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
Must be able to communicate with others to exchange information.
Ability to travel 50%
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines.

Responsibilities

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.
Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
Perform miscellaneous duties as assigned.