
Céline Leparquier
Clinical and Regulatory Affairs Director
Biological Engineer with 18 years of Clinical research experience including 12 years of Clinical Project Management experience in a wide range of therapeutic areas. Managed large phase I-II to IV global trials with up to 8 countries, more than 70 sites and up to 220 patients in Europe and the United States.
Céline started her professional career as a Clinical Research Associate for 6 years and became a Project Manager for multiple service projects. In the past 6 years, she has been mainly involved in Oncology trials for Biotechnology Companies.
She is currently the Clinical and Regulatory Affairs Director, acting as the regulatory referent to support the Clinical Project Managers and Project Directors in the context of clinical trial submissions, quality control of submitted documents, regulatory strategy, and regulatory watch.
Experience
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mAb therapy – Phase I/II (5 countries, 14 sites) in solid tumor and hematologic cancers
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Diagnostic mAb– Phase III (4 countries, 10 sites) in CRC
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Peptide vaccine – Phase II trial (8 countries, 70 sites) in NSCLC
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GMO vaccine – Phase I/II trial (2 countries, 11 sites) in HIV
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Gene therapy – Phase I (1 country, 1 site) in rare disease