General Manager - Europe

at  Iovance Biotherapeutics Inc

THE COMPANY

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), is a commercial-stage oncology company and the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient.
The company’s proprietary tumor infiltrating lymphocyte (TIL) therapies use a patient’s own immune cells to attack cancer. TIL cells are extracted from a patient’s own tumor tissue, expanded through a proprietary process, and infused back into the patient, in some cases after genetic modification. Upon infusion, TIL cells attack cancer cells, often leading to durable responses that in many cases extend for years.
In February 2024, the company’s lead product, AMTAGVI™ (lifileucel), was granted the first ever approval for an individualized T cell therapy for solid tumors by the US FDA. AMTAGVI™ is indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under an accelerated approval based on overall response rate and duration of response. Authorized Treatment Centers (ATCs) will administer AMTAGVI™ to patients as part of a treatment regimen that includes lymphodepletion and a short course of high-dose PROLEUKIN® (aldesleukin).
Currently, more than 50 ATCs in the US have been onboarded, with that number expected to increase to 70 by the end of 2024. A marketing authorization application for AMTAGVI™ was submitted to the European Medicines Agency in June of 2024 with additional submissions planned through 2025 and 2026 in the UK, Canada, Australia, and beyond. Submission for the UK is anticipated to be approved in the first half of 2025. Further potential approvals under the EMA are expected for the second half of 2025.
Iovance is also conducting TILVANCE-301, a Phase III trial to confirm the clinical benefit of AMTAGVI™ in combination with pembrolizumab as a frontline treatment for melanoma, expanding the current US label to thousands of additional patients each year. Trials examining lifileucel in non-small-cell lung cancer and endometrial cancer as monotherapy and in combination are currently in Phase II and are intended to support approval of these indications in the US. The company’s deep pipeline of next-generation TIL therapies is also rapidly advancing with two different genetically edited TIL products and a next-generation interleukin-2 product in clinical or IND-enabling studies. The company closely collaborates with the US National Cancer Institute and leaders in immuno-oncology around the world.

REQUIRED EDUCATION, SKILLS, AND KNOWLEDGE

• University degree required and MBA or advanced degree considered a plus
• 15+ years of progressive experience in commercial leadership roles in the biopharmaceutical industry, preferably across multiple countries
• Proven track record of devising impactful commercial strategy and executing successful European launches for complex specialty products. Ideally, this experience includes regional and in-country launches.
• Specialty oncology experience is required and experience with complex advanced therapies is strongly preferred
• Demonstrable success operating in-market within the region and at the same time used to successfully collaborate in a global matrix
• Demonstrable experience in building and leading intercultural commercial teams and building positive relationships between local, regional, and global organizations
• Deep knowledge of healthcare dynamics in the European region - specifically of navigating the various reimbursement systems
• Outstanding communication skills (verbal and written), including strong ability to synthesize disparate and complex inputs into clear and concise conclusions and recommendations
• Ability to anticipate issues and respond quickly, flexibly, and creatively to solve problems and address commercial market challenges
• Experience developing, managing and maintaining relationships with governments, regulators, other relevant authorities and external service providers
• Superior organization, analytical and project management skillsStrong business and financial acumen - good at budgeting forecasts and reporting and planning activities

THE ROLE

Reporting to the Chief Commercial Officer, the General Manager, Europe will play a key role in shaping the future strategic direction of Iovance to ensure continued organic growth. They will spearhead the development and execution of Iovance’s commercialization strategy for AMTAGVI™ and Proleukin® in Europe, as well as launch strategies for future pipeline indications and programs. The General Manager will establish the European commercial organization and focus on driving market adoption of Iovance’s products across the region. With full P&L and responsibility for growing and leading Iovance’s operations in Europe, the GM will build the optimal organization to ensure the successful approval and launch of AMTAGVI™ and Proleukin® and prepare the ground for other pipeline products. This individual will also be in charge of developing the regional strategy and selecting partners, as appropriate, to commercialize Iovance products. This role requires a strategic approach to identifying, assessing, and prioritizing geographic and clinical market opportunities.
The General Manager will be a senior member of the Global Commercial Management Team, will head the European leadership team, creating the team and its structure, partnering with key corporate and CMC functions, and for the subsequent development and operational execution of the commercial strategy for the European region. They will be responsible for developing the market-entry strategy, including optimization of sales channels and geographic focus. This also encompasses partnerships, co-marketing agreements or in-house marketing, and sales activities.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Working closely with the CCO and global resources to create a high performing, integrated European organization by developing a strong regional business strategy and executing associated tactical initiatives, financial plans, and staffing requirements, etc. that are required to drive and sustain commercial delivery within the region
• Establishing all commercial infrastructure in Europe and strategic direction for the region including sales, marketing, commercial case management and patient support services, government and external affairs, and business analytics
• Ensure alignment and effective matrix management of corporate and regional cross-functional resources including, but not limited to, Marketing, Supply Chain / Manufacturing, Medical Affairs, Regulatory Affairs and Clinical Development, etc. to ensure timely design and on-time product delivery for a complex, individualized cell therapy
• Deliver strategic leadership to drive the commercial path to growth and profitability for Iovance and establish an effective growth process for the region
• Be responsible for a timely Market Access strategy and its execution, driving the patient identification process and building patient support framework and therapy development activities
• Collaborate with business partners within the company to ensure appropriate messaging, programs, and materials for success with key accounts, market access stakeholders and health authorities
• Develop and execute a pre-launch awareness strategy and ensure commercially attractive product profiles by engaging with patient advocacy groups and KOLs
• Establish, safeguard, and strengthen the reputation of Iovance with KOLs, regulators, payors, patient organizations, and other relevant stakeholders
• Be a hands-on driver of the business and European launch teams by supporting country operations intensely to ensure successful results
• Develop congress and meeting strategies and objectives
• Participate as an active member of the Commercial Leadership Team to shape all aspects of commercial and business strategy, commercial planning and operations, and manufacturing supply planningContribute to the company’s patient-focused culture and demonstrate effective partnering across business functions and levels and be a true leader to the European organization at Iovance