Executive Director, Authorized Treatment Center (ATC) Cell Therapy Operations

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 Executive Director, Authorized Treatment Center Cell Therapy Operations will be an integral member of the Iovance Leadership team, working closely and collaboratively with both treatment center staff (physicians, surgeons, nurses, administrators, quality personnel) and with a broad range of Iovance functions (e.g., Commercial, Quality, Manufacturing) to achieve pre-launch and post-launch KPI’s pertaining to prioritized treatment center authorization and infrastructure development.

Essential Functions and Responsibilities

Build and lead a team of talented cellular therapy operational experts responsible for achieving overall treatment center authorization and Iovance key objectives for commercialized TIL therapy.

Direct the ATC Cell Therapy Operations team on strategy formulation and tactical execution to ensure that the identified treatment centers are fully qualified and prepared for commercial launch.

Lead, develop, and expand Iovance and ATC Cell Therapy Operations strategy and project plans to ensure the achievement of goals and objectives and continuous improvement within the department and cross-functionally, including QA, Commercial, IT, Medical Affairs, and Manufacturing.

Serve as an internal expert and partner cross-functionally to address complex issues related to Cell Therapy operations, COI/COC, treatment center authorization, and the development of key business infrastructure.

Demonstrates excellent communication skills with the ability to articulate issues and impact team decisions. Communicates with all levels within Iovance and represents the organization externally through presentations, meetings, and events.

Plan and manage individual and team achievements in alignment with launch objectives and ATC qualification and authorization language, as directed by the BLA application and FDA guidance.

Ensure achievement of milestones (and subsequent documentation) through frequent collaboration with team members and their assigned treatment centers.

Develop operational dashboards and reports to demonstrate progress against KPI’s and compliance.

Establish policies, processes, and systems (e.g., tumor collection, courier, order intake) and ensure thorough evaluation, change control, and implementation.

Create post monitoring strategies of authorized treatment centers.

Maintain technical and professional knowledge by reviewing Iovance documentation, SOPs, attending professional conferences, and continuing to build upon professional networks.

Utilize clinical and operational expertise to develop processes that assist with and drive the timely resolution of treatment center questions, issues, and investigations.

Provide departmental oversight to ensure close collaboration with Iovance’s Quality Department and the treatment centers related quality processes such as change control.

Partner with industry organizations and other cell therapy partners for discussions pertaining to the quality and regulatory landscape for Cell Therapy Operations at the treatment center level.

Other duties as assigned.

Travel

• 50% of the time.

Required Education, Skills, and Knowledge

Master’s Degree BA/BS degree in biological sciences, nursing, or other health sciences.

Minimum 15+ years of experience in a healthcare environment, preferentially in nursing, clinical operations, surgical oncology, cell therapy or transplant/infusion.

Seven years of leadership experience required.

In-depth clinical and operational expertise in the field of Oncology and Cellular Therapy, as well as healthcare and academic hospital insights and understanding.

Experience leading teams and facilitating process improvement and quality management activities.

Track record of demonstrated achievements: both individual and team-oriented.

Strong facilitation and communication skills, both verbal and written.

Strong analytical skills with experience in cell therapy environment metrics, outcomes, and using data tracking tools.

Problem-solving skills and multi-tasking experience are critical.

High level of proficiency in Microsoft Excel, Word, and PowerPoint is required.

Capable of meeting deadlines and multi-task efficiently in a fast-paced environment.

Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

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. Please contact Human Resources to request an 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.

The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.