Experience

PKvitality

• France
• Biotechnology Research
• 1 - 100 Employee

• Clinical and Medical Manager

  • Nov 2020 - Present

  Chief of Clinical, Regulatory and Quality Affairs | Feb 2023 – May 2023 • Comex’ s member • Clinical and Medical Affairs management • Supervision of QMS according to ISO13485 • Implementation of the regulatory strategy for PK’s products according to local requirements and project input • Management of 2 teams Clinical & medical manager | Nov 2020 – Jan 2023 • Clinical strategy (CEmark, 510k), study set up in US (NSR trials), interactions with CRO and investigators, data manager, CRA. Design and writing of study documents • Development of clinical department, Set up an European Clinical Board • Set up medical device vigilance • Biocompatibility: Development of preclinical plan, Components analysis, design and GLP studies, biologic interpretation (BER, BRA) • Translational participation to K’Watch project with other teams • Management of 5 people Show less



Septodont

• France
• Medical Equipment Manufacturing
• 700 & Above Employee

• Head of Preclinical & Clinical Development

  • Jan 2014 - Nov 2020

  Manager of clinical development. follow up of clinical CRO and interaction with KOL.Manager of preclinical developpement (GLP, non GLP studies, in vitro or in vivo model, in silico). Strong skills on toxicology, extractibles & leachables, calculation of threshold and analysis of risk assessment. Head of medical writing on preclinical and clinical parts (CE Mark, 510K, 2.4 and 2.5 modules) and on scientific articles. More 100 reports submitted and approved by Health authorities.Strong skills on medical devices (all class, bioactive, implantable devices...) and their clinical evaluation, equivalence process, literature search according to appropriate guideline (MEDDEV rev4, ISO 10993...)Management of 5 medical writers and one preclinical & clinical studies officer Show less

• In charge of preclinical & clinical studies

  • Jul 2010 - Jan 2014

  Sélection et gestion des sous-traitants pour la réalisation des études précliniques et cliniques.Coordination des études précliniques et cliniques dans le respect de la réglementation incluant : Gestion administrative, réglementaire et budgétaire des études précliniques et cliniques.Suivi du bon déroulement des études précliniques et cliniques. Contrôle de la qualité des études précliniques et cliniques et du respect de la réglementation. Suivi des évènements indésirables en relation avec la pharmacovigilance.Contrôle des rapports externes précliniques et cliniques. Show less



AgroParisTech

• France
• Higher Education
• 700 & Above Employee

• PHD Student

  • Jan 2007 - May 2010

  PhD: Effect of lactoserum protein on bone physiology by modulation of immunity PhD: Effect of lactoserum protein on bone physiology by modulation of immunity