Project Manager
Andrii brings 11 years of dedicated experience in the clinical research industry and 4 years in pharmaceutical sales. His expertise encompasses project management of clinical trials, site monitoring, and team leadership. With a solid foundation in therapeutic areas such as oncology and endocrinology, Andrii has successfully managed numerous clinical studies from initiation to completion. His insights into patient care and regulatory requirements position him as an invaluable member of the early phase unit team at Accelsiors.
Associate Director Project Oversight – Project Management
Dora is a clinical research professional with over 18 years of experience in the pharmaceutical and clinical research sectors. She specializes in project management across various therapeutic areas, including oncology, endocrinology, and infectious diseases. With a strong background in leading Phase I to Phase IV clinical trials, Dora excels in overseeing clinical operations and ensuring quality compliance throughout the study lifecycle. Her profound expertise in drug development and risk-based monitoring makes her a vital asset to the early phase unit at Accelsiors.
Senior Director, Quality Management
Miodrag is a qualified medical professional with a PhD in Virology, and nearly 20 years of experience in vaccines and biotech development. His background includes microbiological assessments and expert documentation for Clinical Trials and Marketing Authorization applications. He has a proven record in Quality Management Systems (QMS), audits and compliance with ISO 9001 and 17025 standards, as well as in GMP/GCP inspections. As the Head of the Quality Management Unit at Accelsiors, he upholds stringent quality standards and regulations, while collaborating with respected organizations like Ph. Eur./EDQM and WHO to enhance the company’s influence in the industry.
Vice President – Data Management &
Data Integration
Philippe is an expert in Data Management with over 30 years of experience, making him a critical member of Accelsiors and the Phase I unit. During his distinguished he has been a driving force behind advancements like Electronic Data Capture (EDC), Decentralized Data Management, Central Monitoring, and the Risk-Based Approach. Philippe’s extensive background spans major pharmaceutical companies and biotech firms, equipping him with a unique perspective on clinical data operations. His deep expertise and innovative approach enable Accelsiors to effectively harness data, ensuring quality compliance and enhancing the efficiency of early phase trials.
Vice President – Clinical Pharmacology, Modelling & Simulation
Stefan is a highly experienced professional in clinical research and statistical analysis, boasting a distinguished career with significant roles at Novartis and Sandoz, including Statistical Expert and Head of Clinical Development. His expertise encompasses CRO approval, bioequivalence study planning, and statistical analysis, making him a vital asset at Accelsiors. Stefan has contributed to critical projects in manufacturing process control and FDF development, culminating in 29 peer-reviewed publications. His deep knowledge in PK and PKPD modeling, coupled with experience in staff training, further underscores his capability to enhance operations and drive innovation within the organization.
Vice President – Scientific Affairs
As a board-certified internist and holder of a PhD in Clinical Sciences, Tímea brings an exceptional blend of clinical, academic, and statistical expertise to her role. Since joining the organization in 2016 as a Biostatistician, she has evolved into a key leader in Scientific Affairs, guiding strategic initiatives and overseeing critical operations. Simultaneously, she fulfills the line management role in medical writing and supports Accelsiors’ central and medical monitoring activities, showcasing her diverse skills and ability to drive excellence across multiple domains within Accelsiors.
