Director, Clinical Science

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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

• Participate in Clinical Development Core Team, Clinical Sub-Team, and operational meetings • Interface with cross-functional teams including Biomarkers, Biometrics, Clinical Operations, Regulatory Affairs, Quality Assurance, Translational Medicine, and others • Support development of clinical science strategies, Lifecycle Plans, commercialization plans, and Clinical Trial Plans • Gather and analyze data and information for Clinical Science plans • Provide clinical science support for assigned studies and programs • Conduct literature searches and provide input on clinical study designs • Design clinical protocols, manuals, and forms with guidance from Medical Directors/Clinical Science Physicians • Develop and review informed consent, eligibility, dose modification, safety, case report forms, protocol summaries, monitoring plans, investigator brochures, and related documentation • Coordinate document completion, protocol amendments, site training, and clinical review of study data • Review and discuss clinical study reporting and safety-related documents • Prepare clinical presentation materials, abstracts, posters, scientific meeting content, and regulatory documentation • Support communications strategies involving KOL interactions, advisory boards, medical meetings, publications, and study communications • Coordinate submissions to scientific meetings and regulatory filings • Complete or lead special projects and comply with laws, regulations, Iovance SOPs, and guidelines

🎯 Requirements

• 7+ years’ clinical trial experience with relevant therapeutic area experience • 2+ years’ experience in clinical science • Data listing review experience is mandatory • Experience authoring experimental protocols and/or study results and conclusions • In-depth understanding of Phase 1 through 4 drug development • Strong analytical skills for interpreting scientific research and literature • Experience with data analysis, interpretation, and clinical relevance • Comprehensive understanding of product and safety profiles • Knowledge of GCP, ICH, FDA, EMEA, NICE, and other relevant guidelines and regulations • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel) • Working knowledge of multidisciplinary drug development functions • Excellent project management, prioritization, and budget/timeline management skills • Strong interpersonal, verbal, written communication, influencing, presentation, judgment, and decision-making skills • Ability to travel approximately 25% • Ability to sit for an extended time in front of a computer