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Senior management professional with 25+ years of combined pharma, CRO, academic and laboratory experience in the pharmaceutical research industry. Intrinsically motivated to make a difference in any position. Keenly interested in all aspects of (medical) research and healthcare, and excited to learn and contribute to success stories.

A scientist by education and a generalist by nature, I have a broad experience in a variety of roles of increasing responsibility, across several functional areas and with significant international exposure. Functional experience includes project management, quality assurance, regulatory compliance, vendor management, sample management, logistics, investigator services, in addition to business development and general management with HR and P&L responsibility.

I enjoy developing individuals (including self) and teams, improving general business performance and managing change. Looking for a position in a stimulating environment that allows applying general management skills (primarily) and subject matter expertise (where relevant). Not currently open to relocation, but willing to travel and proven to be successful in multi-cultural, matrix management structures.

 

Experiences

Current Experience

  • COO

    Antwerpen, Belgium
    Since September 2017
    Clinical Trial

    Responsible for overseeing operational activities across all laboratory departments as well as departments that support project set-up, project execution and the delivery of results. Fostering collaboration across EU and US locations and functions. Implementing and supporting cross-functional teams to address operational challenges, identify opportunities and implement enhancements.

    Recent speciality focus includes data protection (appointed as Data Protection Officer in relation to the EU-GDPR), in vitro diagnostic medical device developent (PMA and CE-IVD pathways), clinical trial logistics and addressing regulatory compliance questions.

Past Experience

  • VP, Managing Director, CLS Global Operations Mechelen, Belgium

    July 2015 --- August 2017
    Customer Satisfaction

  • Senior Global Director, Logistics Operations Mechelen, Belgium

    January 2013 --- July 2015
    management

  • Managing Director Mechelen, Belgium

    July 2007 --- July 2015
    Business Development

  • Global Director of QA Mechelen, Belgium

    September 2005 --- July 2007
    Clinical trials

  • Director of QA, Europe Mechelen, Belgium

    November 2000 --- August 2005
    Quality System

  • (Senior) Quality Assurance Manager Brussels, Belgium

    March 1998 --- October 2000
    Business Development

  • (Senior) QA Auditor Brussels, Belgium

    April 1995 --- March 1998
    Auditing

  • CRA, Local Project Coordinator Brussels, Belgium

    July 1993 --- March 1995
    Patient Recruitment

Personality

Self Assessment :
AdaptabilityAnalytical thinkingApproachabilityAuthenticityCollaborationCoordinationCritical thinkingDependabilityDiligenceFlexibilityInterest in knowledgeOptimismOrganizationPerspectiveProblem solvingResiliencyResponsibilityResult OrientedStrategic thinkingTrust

Knowledge

Self Assessment :
NegotiationAnalytical proceduresAuditingBiologyBiomarkersBudget ManagementBudget ProcessBusiness StrategyCancer ResearchChange ManagementClinical researchClinical SuppliesClinical trial audits and inspectionsClinical trial managementCoachingCommunication SkillsCompliance with regulationsContinuous ImprovementContract negotiationCROCross-functional team leadershipDiagnosticsDrug development processDrug regulatory authoritiesDue DiligenceEnglishGXPHealthcare industryImmunohistochemistry (IHC)In vitro diagnostics (IVD)Informed Consent ProcessInternational RelationsISO 13485ISO 17025ISO 9001Knowledge of the drug development processLaboratory ResearchLeadershipLife SciencesLogisticsmanagementMedical DevicesMergers & AcquisitionsMicrosoft OfficeMolecular DiagnosticsOncology Clinical ResearchOperations ManagementOutlookPathology labspeople managementPharmaceutical DevelopmentPhases of clinical development (phase I to IV)PresentationsPricingProblem SolvingProcess improvementPublic SpeakingQuality Assurance (QA)Quality Management System (QMS)Regulatory ComplianceRestructuringRisk ManagementRoot Cause Analysis (RCA)Standard Operating Procedure (SOP)StrategyTeachingTeam ManagementTranslational Research

Skills and Expertise

Self Assessment :
Create SOPsAnalyse growth / improvement potentialAssign activitiesAttend steering committeeAdvise on strategyCoach staffCommunicationContract approvalCoordinationCreates a collaborative team environmentDevelop ICH/GCP compliant processesDirect co-workersEstablish contractsEstablish professional relationships with partnersExecute internal/external quality assurance assessmentsFollow-up of Quality Management System (QMS) processesImplement Key Performance Indicators (KPI's)Implement Quality Management System (QMS)Lead teamsMaintain Quality Management System (QMS)Manage complexityManage vendor budgetsMonitor Key Performance Indicators (KPI's)NegotiationOrganise meetingsPeople managementPrepare responses to health authority queriesProvide trainingReview vendor metricsSelect contractors Train StaffWork cross-functionally

Education

  • PhD in Developmental Biology from KU Leuven, Belgium in 1997
  • Post Graduate in Life Sciences Teacher from KU Leuven, Belgium in 1991
  • Master in Biology from KU Leuven, Belgium in 1989

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
French
Professional Proficiency

Work Preferences

  • Positions I am interested in:
    CEO Clinical Operations Manager Compliance Manager Director Regulatory Affairs General Manager Manager Managing Director Operations President Senior Consultant Team Leader Associate Director Clinical Operations Lead Consultant Management Consultant Project Leader QA Consultant Quality manager
  • Locations I am interested in:
    Belgium
  • Work From Home:
    Yes, 0 to 3 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Leuven, Belgium

Others

Driving License
  • Yes

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