Gergely Balint
Global Asset Lead, Oncology @Nerviano Medical Sciences - Part Of Nms Group
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WORK HISTORY
Global Asset Lead, Oncology @Nerviano Medical Sciences - Part Of Nms Group
Boston, MA, US
Responsible for leading the integrated strategy for 1-2 early clinical phase oncology assets in heme and solid oncology indications. Main activities:• Leading all aspects of the development of an oncology product from early development to approval and market entry.• Accountable for leading the cross-functional product strategy team to develop the strategy for the product in the target therapeutic area, gain approval for that strategy with leadership and drive the efficient execution of the approved strategy, on time and on budget.• Coordinates between all internal/external stakeholders to ensure alignment, operational efficiency and program success. • Responsible for driving project performance, risk management, administration, financial management and issue resolution for the cross-functional team.• Ensures quality and compliance of the program team in line with company expectations• Contribute to the identification and evaluation of potential partnering and BD opportunities
EDUCATION
Eötvös Loránd University / Semmelweis Medical University
Master of Science (MSc), Humanbiology and Neuroscience
SKILLS
ABOUT GERGELY BALINT
Highly accomplished leader of pharmaceutical industry with wide range of experience in project and organizational leadership. 20+ years of international drug development expertise coupled with strategic, operational and management experience. Core competencies/experience include Extensive Early and Late-stage Drug Development/Life Cycle Management Immunology, Oncology (solid & hematologic), Neurology, Rare Disease Hands on Project & Program Leadership Developing High Performing Teams People management and mentoring Product Strategy Development IND, BLA submission, regulatory consultations (EMA/FDA/PMDA) US, EU, & International Experience Change Management Strategic Alliance Experience Due Diligence and reverse Due Diligence processes Key Accomplishments Building out project and portfolio management processes and capabilities Successfully building and managing high performing US operations of 16 FTEs to execute the established global company strategy in challenging environment. Developed asset for Phase ready by driving a clinical phase project of unprecedented results for an indication with high unmet medical need. Provided insightful consultation with FDA and explored potential regulatory pathway options for a drug candidate of a novel class. Planned and drove the execution of a BLA label-extension dossier preparation for a blockbuster product in multiple sclerosis. Successfully set-up of the new Integrated North-East Asian Regional R&D hub concept that maximized the value of global development projects. Passed FDA inspection without critical or major findings of a large 1300 patient pivotal in-house phase study.
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