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With almost 20 years experience in multinational and start-up organizations. Dynamic, entrepreneurial, innovative, sklled at managing both projects and people, able to motivate a team towards achievement of the objectives, excellent communication and negotiation skills. Excellent knowledgement of Clinical /non-interventional trials, registries management (from designing of protocol to study report) within EMEA and US area Involvement on non clinical and preclinical activities Involvement on the development of Post Approval studies, Real World Data to reach regulatory environment, marketing ..... target Good understanding of Health Economics and Market Access (negotiations, dealing with authorities, payors, stakeholders)

Experiences

Current Experience

  • Clinical Expert Consultant


    Since May 2014

  • Independent Expert Evaluator


    Since January 2014
    Expert Independent Expert for European Commission assists with research and innovation assignments including the evaluation of proposals, monitoring of projects, and evaluation of programmes, and design of policy. Assignments mainly concern research and innovation, falling within the Horizon 2020 programme designed to address the challenges Europe is facing through funding excellent science, technology and innovation.

  • Managing Director // Freelance Consultant and business owner


    Since July 2011
    Drug Development Freelance Consultant and business owner Expert on Clinical developement and execution of programs ( Phase I to IV, Post-Approval Studies, Real World Data, Observational studies..........) Outcomes Research......................... Helping clients optimise the drug development pathways of their products through Europe Midle East Africa area Designing of programs/projects strategy from study feasibility to report or submission

Past Experience

  • Clinical Research Expert

    July 2011 --- March 2013
    Clinical research

  • Professeur - invité

    January 2006 --- January 2013

  • Professeur - invité

    January 2006 --- January 2013

  • Health Outcomes Research Manager

    September 2008 --- July 2011
    Health Care

  • Global PM / Head of Customer Services Late Phase

    January 2006 --- September 2008

  • Global PM

    January 2004 --- January 2006

  • Chef Projet

    January 2001 --- January 2004

Personality

BrightOwl Assessment :
ResiliencyPerspectiveDiligenceStrivingSociabilityCreative thinking

Knowledge

BrightOwl Assessment :
Good Clinical Practice (GCP)Good Clinical Practice (GCP)Emergency medicinePhases of clinical development (phase I to IV)Preclinical regulations and practicesClinical DevelopmentNegotiation
LinkedIn Assessment :
Clinical trialsClinical DevelopmentPharmaceutical IndustryCRORegulatory affairsGCPBiotechnologyClinical researchCTMSoncologyPharmacovigilanceLifesciencesCross-culturalCross Functional Team BuildingPartnership-buildingLeadershipRegulatory submissionsHealthcareOutcomes ResearchClinical monitoringICH-GCPHealth EconomicsMarket accessProtocolMedical affairsVaccinesImmunologyClinical Data Management (CDM)CancerDrug DevelopmentTherapeutic AreasMedical writingElectronic Data Capture (EDC) SOPHematologyCardiologyFDANeurologyPharmaceuticspharmacologyRegulatory RequirementsBiopharmaceuticalsDrug Discovery

Skills and Expertise

BrightOwl Assessment :
Develop ICH/GCP compliant processesPlan work to meet objectives and deadlinesEnsure good clinical practice (GCP)Supervise clinical monitorsCoach and provide guidance to clinical staff.Develop and maintain tracking systemsEthics committee submissions

Education

  • MBA (Pharma mini Executive) in Pharmaceutical Sciences from London Business School in 2012
  • PhD in Boichemystry / Immunology from Université Pierre Marie Curie (VI) France in 1996
  • in from Université Pierre et Marie Curie (Paris VI) in 0000

Area / Region

Belgium

Others

Driving License
  • Yes

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