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Summary

- Wide experience and passion for Clinical Affairs in the healthcare sector. - Extensive strategic expertise in coordinating the design, planning and execution of a clinical trial portfolio (all phases, incl. R&D, regulatory, post approval and investigator trials), respecting timelines, budgets and standards. - Global experience (North America, Europe, Middle East, Asia, Japan, Australia) & large experience with Key Opinion Leaders and CROs. - Solid team leader experience (internally and externally) with a passion for empowering people. - Extensive capabilities in change management, process improvement, trial acceleration, budget reduction. - Ability to be a pragmatic issue solver and team player, focused on action.

Experiences

Current Experience

  • Senior Director Clinical Affairs Europe, Transcatheter Mitral Valve Replacement
    Since April 2016
    TBA

Past Experience

  • VP Global Clinical Trials (Cardiac Rhythm Management & Electrophysiology)
    October 2012 --- November 2014
    Worldwide responsible for strategy, planning and execution of pre- and post-market clinical trials (North America, South America, Europe, Middle East, Asia, Australia/NZ). In charge of a team of 140 people.

  • VP Global Clinical Operations (Cardiology, Rhythm and Vascular)
    April 2010 --- September 2012
    Responsible for worldwide clinical operations (site opening, data & safety management, monitoring, biostatistics) serving 4 divisions. In charge of a team of 300 people.

  • Director Clinical Programs International (Cardiac Rhythm Management)
    January 2007 --- January 2010
    Responsible for strategy and execution of pre- and post market trials run in international. In charge of a team of 50 people.

  • Several clinical & research positions
    January 1996 --- January 2010

Knowledge

LinkedIn Assessment :
LeadershipClinical trialsClinical AffairsClinical researchTeam LeadershipMedical DevicesFDAStrategic PlanningPharmaceutical IndustryRisk ManagementCardiologyRegulatory affairsISO 13485CROLeadership AccountabilityStrategic InfluenceListenCustomer SatisfactionDecision MakingChange ManagementAccountabilityCreativity SkillsCoachingCRMResynchronisation TherapyPacemakersDefibrillatorBiomedical EngineeringCross-functional team leadershipStrategy

Education

  • PhD in Applied Sciences, Biomedical Engineering from Université de Liège in 1991
  • Civil Engineer in Civil Engineer from University of Liège in 1986

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency
Dutch
Elementary Proficiency
German
Elementary Proficiency

Area / Region

Evere

Others

Driving License
  • Yes