Clinical Business Operations Lead

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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

• Track and communicate clinical portfolio, program, and study progress to Senior Management using dashboards and trackers • Assess data to detect trends and outliers and direct resources to correct problems early • Develop and track clinical operations and vendor performance KPIs • Support program-level meetings and governance forums, including setup, minutes, and action-item follow-up • Create solutions for clinical trial scenario planning, early budget planning, and predictive enrollment forecasting • Contribute to clinical study document preparation and eTMF support as needed • Assist with inspection and audit readiness activities • Serve as clinical representative at hypercare and S&OP • Serve as clinical representative on the IovanceClinical Platform • Adhere to company values, policies, procedures, and business ethics • Perform miscellaneous duties as assigned • Travel as needed

🎯 Requirements

• Bachelor’s degree with 4+ years of pharmaceutical, biotech-related, clinical research, oncology, or research experience, or Master’s degree with 3+ years of such experience • Experience designing, initiating, and managing Phase 1–4 clinical trials • Experience managing CROs and selecting ad hoc clinical trial vendors • Excellent interpersonal and communication skills with demonstrated leadership attributes • Subject matter expertise applying US and global regulations and guidance, including SOPs, ICH-GCP, FDA-CFR, and ethical standards • Ability to remain stationary 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/constantly • Visual acuity for preparing and analyzing data and figures, viewing computer screens, and extensive reading • Ability to perform repetitive wrist, hand, and/or finger motions • Ability to communicate with others to exchange information • Clear conceptual thinking, judgment, troubleshooting, problem-solving, analysis, discretion, stress management, multitasking, and deadline management • Available to travel as needed

🏖️ Benefits

• Annual base salary of $145,000–$155,000 USD • Remote work option • Reasonable accommodations may be made upon request • Diverse and inclusive work environment • Equal-opportunity employment