About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com.
Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com.
Overview
The Senior Director, Authorized Treatment Center (ATC) Cell Therapy Operations leads the strategy, team, and operational performance of Iovance’s treatment-center network. This role oversees center authorization, readiness, ongoing support, and network growth to support patient access and reliable treatment coordination. Working with treatment-center leaders and internal partners, the Senior Director sets operational standards, manages resources and risks, and prepares the network for new indications and changing business needs.
Essential Functions and Responsibilities
- Lead and develop the ATC Operations team, with clear responsibilities, staffing plans, workload allocation, coaching, and succession planning.
- Set the ATC network strategy, multiyear plan, and annual objectives based on patient access, geographic coverage, referral demand, center capacity, performance, and anticipated growth.
- Oversee center authorization, onboarding, readiness, ongoing support, monitoring, remediation, reauthorization, and deactivation, as applicable; ensure required milestones and documentation are completed.
- Provide operational leadership across tumor procurement, order intake, logistics, manufacturing coordination, and treatment readiness, including chain of identity and custody and supporting systems. Coordinate responsibilities with Commercial, Quality, Manufacturing, Supply Chain, Regulatory, Medical, and treatment-center teams.
- Lead operational reviews with company and treatment-center leaders; communicate performance, capacity, risks, and priorities, resolve issues across functions, and track decisions and actions to completion.
- Maintain ATC operating standards and training requirements that reflect approved labeling, regulatory commitments, applicable guidance, and company policies, in partnership with Quality, Regulatory, and Medical.
- Set performance measures for center readiness, capacity, throughput, turnaround times, support demand, compliance, and center experience; use results and center feedback to prioritize improvements.
- Simplify and standardize processes, systems, tools, communications, and support according to center volume, complexity, experience, and risk.
- Establish escalation procedures and response expectations for operational incidents and recurring issues. Partner with Quality on investigations, root-cause analysis, corrective and preventive actions, and verification that actions are effective.
- Represent Iovance in relevant industry forums and partnerships; assess changes in cell therapy practices, quality, regulation, access, and logistics and incorporate relevant findings into ATC standards and team training.
- Oversee business-continuity and contingency plans for courier disruptions, tumor collection constraints, manufacturing interruptions, system outages, and other events that could delay
- Forecast staffing, vendor, and technology needs; develop resource plans and manage the ATC Operations budget to support network growth and changing
- Lead ATC readiness for new indications and other assigned operational initiatives, with defined responsibilities, timelines, and measures of completion.
- Commitment to Iovance Biotherapeutics’ core values, policies, procedures, compliance requirements, and standards of business ethics.
Travel - 35% of the time.
Required Education, Skills, and Knowledge
- Bachelor’s degree in biological sciences, nursing, health sciences, business, operations, or a related field required.
- At least 10 years of progressive experience in biopharmaceutical, oncology, cell therapy, healthcare operations, clinical operations, treatment-center operations, or a related environment.
- At least six years of people-leadership experience, including responsibility for organizational capability, performance management, coaching, talent development, and succession planning.
- Demonstrated experience supporting commercial-stage therapy and expanding or improving cell therapy treatment-center operations after
- Deep understanding of oncology and cell therapy operations, including the operational requirements of academic medical centers, transplant or infusion programs, and community oncology settings.
- Experience managing the treatment-center lifecycle, including identification, qualification, authorization, onboarding, readiness, ongoing support, monitoring, remediation, and reauthorization.
- Working knowledge of the end-to-end cell therapy patient and product journey, including chain of identity and custody, tumor procurement, order intake, logistics, manufacturing coordination, treatment readiness, and supporting systems.
- Demonstrated experience establishing governance, managing escalations, mitigating operational risk, and leading cross-functional decisions in a complex, regulated environment.
- Experience with quality systems and continuous improvement, including investigations, root-cause analysis, corrective and preventive actions, change control, issue trending, and inspection readiness.
- Ability to translate approved labeling, regulatory commitments, policies, and procedures into practical operating processes and treatment-center requirements.
- Experience in strategic and network planning, capacity management, budget management, resource forecasting, and business-continuity planning.
- Ability to develop and interpret operational measures and trends to support decisions and improve performance.
- Strong communication, negotiation, and problem-solving skills; ability to explain complex issues clearly, advise senior leaders, resolve competing priorities, and secure decisions across teams without direct authority.
- Proficiency with Microsoft Excel, PowerPoint, and Word.
Preferred Qualifications
- Advanced degree in science, nursing, healthcare administration, business, operations, or a related discipline.
- Experience with business intelligence, workflow, customer relationship management, quality, or operational management systems.
- Experience with treatment-center network expansion, new-indication readiness, or improvements to commercial launch operations.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.
Physical Demands and Activities Required
- 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.
Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment
This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
#li-remote
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
