Izaskun Elorza
Director Clinical Development Immunotherapy @BioNTech SE
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WORK HISTORY
Director Clinical Development Immunotherapy @BioNTech SE
Clinical Development strategies for Immunotherapies against solid tumors, focusing on protocol development and regulatory submissions.• Execution of clinical trials for Autogene Cevumeran, personalized inmmunotherapy, ensuring patient safety through rigorous medical monitoring and data quality thanks to solid experience in medical data review. AI enhanced skills and data-driven decisions based on data analysis and business intelligence training.• Collaboration with multidisciplinary teams to operationalize complex clinical trials involving autologous tissue samples and individualized IMP. • Medical Affairs activities building partnerships with stakeholders to strengthen project outcomes.
EDUCATION
Accreditation Council for Medical Affairs
Board Certified Medical Affairs Specialist (BCMAS)
Regulatory Affairs Professionals Society
Certificate in Pharmaceuticals
University of Valencia
Post-graduate Diploma on CAR-T and Cellular Therapy
Universitat Autònoma de Barcelona
Doctor of Medicine (M.D.), PEDIATRICS
Universidad de Zaragoza
Postgraduate Course, Lysosomal Metabolism Disorders
University of Navarra
Licentiate degree, Medicine and Surgery
University of Valencia
Post-graduate Master degree on Hematopoietic Stem Cell Transplantation
ABOUT IZASKUN ELORZA
MD, Ph.D. in Pediatric Hemato-Oncology with broad clinical and research background in Immunotherapy, Hematopoietic Stem Cell Transplantation, and Cell and Gene Therapy. I worked as a Senior Consultant in HSCT Unit for more than 15 years in Spanish reference centers for the diagnosis and treatment of patients with cancer, rare diseases, and genetic disorders. I participated as investigator in multiple traslational and pharmaceutical clinical trials. In 2021, I transitioned to Parexel as medical responsible of Cell and Gene Therapy clinical development projects as Senior Medical Director, supporting scientific, clinical, operational, regulatory and business teams. Experience in clinical trials for adult population with hematological diseases, and cancer, from early to late stages. I am Board Certified Medical Affairs and Regulatory Affairs in Pharmaceuticals. From 2024, I am Director of Clinical Development in BioNTech SE, focused on early and pivotal trials with immunotherapies for patients with solid tumors. Always focused on looking for the best treatment option for each patient. Passionate about the immune system and genetic technology as life-transforming therapies. Grateful for living in these exciting times. Always learning….Thank you to all people who wake up daily to improve others\' lives.
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