Executive Director, Authorized Treatment Center – Cell Therapy Operations

Job not on LinkedIn

🔥 5 minutes ago

🇺🇸 United States – Remote

💵 $280k - $300k / year

⏰ Full Time

🔴 Lead

😶‍🌫️ Therapist

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Iovance Biotherapeutics, Inc. is pioneering a transformational approach to treating cancer by harnessing the human immune system's ability to recognize and attack diverse cancer cells in each patient. The company focuses on T-cell-based immunotherapy, specifically Tumor Infiltrating Lymphocyte (TIL) therapy, which involves reinvigorating a patient’s TILs to fight cancer. Iovance's TIL therapy is being investigated in clinical trials across multiple advanced solid tumor cancers. Additionally, the company is advancing genetically modified TIL therapies and exploring potential applications of PBL (peripheral blood lymphocyte) therapy for blood cancers. As a leader in cell therapy, Iovance owns a state-of-the-art Cell Therapy Center in Philadelphia for manufacturing their therapies using proprietary GMP. The company is at the forefront of developing personalized and patient-specific cancer treatments.

📋 Description

• Build and lead a team of cellular therapy operational experts responsible for treatment center authorization and Iovance objectives for commercialized TIL therapy • Direct strategy formulation and tactical execution to ensure treatment centers are qualified and prepared for commercial launch • Lead and expand Iovance and ATC Cell Therapy Operations strategy and project plans, including cross-functional continuous improvement with QA, Commercial, IT, Medical Affairs, and Manufacturing • Serve as an internal expert on Cell Therapy operations, COI/COC, treatment center authorization, and business infrastructure • Represent the organization externally through presentations, meetings, and events • Plan and manage individual and team achievements aligned with launch objectives, ATC qualification and authorization language, the BLA application, and FDA guidance • Ensure milestones and documentation through collaboration with team members and treatment centers • Develop operational dashboards and reports tracking KPIs and compliance • Establish and implement policies, processes, and systems for tumor collection, courier operations, and order intake, including evaluation and change control • Create post-monitoring strategies for authorized treatment centers • Maintain technical and professional knowledge through Iovance documentation, SOPs, conferences, and professional networks • Develop processes to resolve treatment center questions, issues, and investigations • Provide departmental oversight of quality processes and collaboration with Iovance’s Quality Department and treatment centers • Partner with industry organizations and cell therapy partners on the quality and regulatory landscape • Travel 50% of the time • Perform other duties as assigned

🎯 Requirements

• 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 Oncology and Cellular Therapy, healthcare, and academic hospital environments • Experience leading teams and facilitating process improvement and quality management activities • Demonstrated individual and team-oriented achievements • Strong verbal and written facilitation and communication skills • Strong analytical skills with experience in cell therapy environment metrics, outcomes, and data tracking tools • Problem-solving and multitasking experience • High proficiency in Microsoft Excel, Word, and PowerPoint • Ability to meet deadlines and multitask efficiently in a fast-paced environment • Adherence to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics • Ability to remain standing or sitting for prolonged periods • Ability to move inside an office and exert up to 10 pounds of force occasionally or negligible force frequently or constantly • Visual acuity for data and figures, computer screens, and extensive reading • Ability to perform repetitive wrist, hand, and finger motions • Ability to communicate with others to exchange information • Clear and conceptual thinking, excellent judgment, troubleshooting, problem-solving, analysis, discretion, stress management, prioritization, and deadline management

🏖️ Benefits

• Reasonable accommodations may be made upon request to enable individuals to perform essential functions • Equal-opportunity employment • Diverse and inclusive work environment