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Summary

experienced in Drug Development and Medical Device development from Discovery till Marketing: - leading and managing teams. - strategic and tactical management. - development of Outsourcing, vendor selection/management Strategy related to (pre-)Clinical trials, Manufacturing and Operations. -  - worked in Clinical Development at big pharma, sme biotech, CRO’s... - orphan drug experience

Experiences

Current Experience

  • Director Early Development & Project Management


    Since August 2013

Past Experience

  • Director Clinical Operations

    May 2007 --- July 2013
    current role as Director Clinical operations encompasses the roles of: - clinical project Director (responsible for all timelines / Budgets for all running clinical projects) - Clinical operations Director (Line Management/Training) of clinical program managers, clinical supplies, Clinical Research Associates, Clinical Trial assistants, ...) - Outsourcing manager: first point of contact for all third parties - strategic alliance manager: for our partnership with one preferred provider. - internal strategic management for future projects.

  • Trial Manager

    August 2006 --- April 2007

  • Senior Clinical Research Associate (CRA)

    April 2005 --- August 2006

  • Clinical Research Associate (CRA)

    July 2003 --- April 2005

  • Medical Sales Representative

    November 2001 --- June 2003

Personality

Self Assessment :
EfficiencyFlexibilityProblem solvingResult OrientedStrategic thinking

Knowledge

Self Assessment :
Medical devices Phase I R&D NegotiationAntibodiesBiological Drug DevelopmentClinical DevelopmentClinical operationsEarly development stageOperations ManagementPharmaceutical DevelopmentPhase IIPhase IIIPreclinical developmentProject Management
LinkedIn Assessment :
Clinical trialsPharmaceutical IndustryClinical operationsClinical researchBiotechnologyMedical DevicesDrug DevelopmentCROOutsourcingoncologyClinical DevelopmentClinical monitoringPhase IICH-GCPInfectious diseasesGCPRegulatory submissionsCardiologyImmunologyVaccinesSOPPharmacovigilanceBiopharmaceuticalsCTMSRegulatory affairsTherapeutic AreasLifesciencesEDCMedical writingINDDrug DiscoveryGLPpharmacologyClinical Data ManagementCancerProtocolMedical affairsVirologyMedicineLife SciencesSOP

Education

  • Master in Biomedical Science from in 2001
  • Bachelor in Biomedical Laboratory Techniques from Simon Stevin Brugge in 1999
  • Middel school in Science from OLV College Oostende in 1995

Languages

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

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Chief Strategy Officer CEO Operations R&D Director Study director President Medical Officer Managing Director General Manager Clinical Director Clinical Director Europe
  • Positions I am NOT interested in:
    Administrative Assistant BioStatistician Clinical Supply Manager Clinical Trial Assistant (CTA) Customer Service Assistant Drug Safety Officer Clinical Data Manager (DM) Clinical Research Associate (CRA)
  • Locations I am interested in:
    Belgium
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    No

Area / Region

Ghent, Belgium

Others

Driving License
  • Yes

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