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Summary

Broadly-skilled scientific professional with 10+ years of experience in the pharmaceutical industry, holding different positions within R&D and Diagnostics. Author on 50+ peer-reviewed publications, including manuscripts and presentations at international conferences.

Experiences

Current Experience

  • Senior Virologist Beerse
    Since August 2010

    As lead virologist for the simeprevir global full development program, my main responsibility is to manage the virology dossier for regulatory filings.

    • member of the global clinical and regulatory teams responsible for clinical trial design/set-up/execution and health authority interactions
    • owner of the virology vendor contracts
    • (co-)author of the in vitro/in vivo virology reports and clinical summary documents for regulatory submissions.

    Additional responsibilities include setting up internal and external scientific collaborations, attending advisory boards, and presentation of virology data to internal/external stakeholders or at major conferences.

     ​​After a successful initial filing for simeprevir in 2013 and supplemental filing in 2014, I’m currently involved in developing new HCV combination treatment strategies to further strengthen the Janssen Infectious Diseases portfolio.

Past Experience

  • Research Associate Mechelen, Belgium
    June 2004 --- August 2010

    In support of the internal Infectious Diseases development programs:

    • Viral geno/subtyping and sequencing assay design in a research environment.
    • Validation and implementation of a fully LIMS integrated resistance testing platform in a CAP/CLIA certified diagnostic lab environment.

Personality

Self Assessment :
Strategic thinkingAnalytical thinkingInnovative thinkingResult OrientedEfficiencyProblem solvingAttention to detailCollaborationApproachabilityCommunicativeIndependenceResponsibility

Knowledge

Self Assessment :
Drug DevelopmentClinical Development R&DDiagnosticsPhases of clinical development (phase I to IV)Infectious diseasesVirologyIn VitroIn VivoSmall moleculesClinical Study DesignGood Clinical Practice (GCP)INDRegulatory submissionsNew Drug Application (NDA)Understanding of regulatory guidelinesReport Writing Scientific writingStudy protocolsClinical study reportsInformed Consent DocumentsStandard Operating Procedure (SOP)CDISCPresentation SkillsGood Publication Practice (GPP)Cross-functional team leadershipRisk ManagementDue DiligenceStrategic PlanningEntrepreneurshipTeamworkBiomedical SciencesBiotechnologyAssay developmentGraphPad PrismMolecular & Cellular BiologyLIMSNucleic Acid ExtractionRNA isolationreal-time PCRnext generation sequencingSequence AnalysisGenetic polymorphismPhenotype

Skills and Expertise

Self Assessment :
Analyze data Develop clinical trial protocols Interpret data Molecular Diagnostics Monitor a clinical study Report data Search literature on clinical trials Write papersAttend investigator meetingAttend seminars, courses and meetings within and outside the companybudgeting of R&D activitiesClinical data collectionCommunicate effectively on different company levelsConduct limited data and/or statistical analysis.Conduct literature searchesCreate clinical documentsDesign clinical trialDesign data collection systemsDesign database Design exclusion criteriaDesign inclusion criteriaDesign scientific experimentsDevelop clinical strategyDevelop regulatory strategyDevelop strong internal relationships with stakeholdersEnsure data integrityEstablish professional relationships with partnersGenerate regulatory submissions Lead teamsManage risksManage vendor budgetsManuscript preparation and reviewOrganise meetingsPrepare investigator brochuresPrepare responses to health authority queriesPrepare regulatory documentsPresent clinical resultsPublication of articlesR&DRegulatory submissionsRegulatory documentationReport study conclusionsReview clinical study reportsReview reportsReview study protocolsReview vendor reportsWrite papersWrite final reports

Education

  • Master in Biomedical Sciences from KUL, Leuven in 2003
  • Bachelor in Biomedical Sciences from VUB, Brussels in 2001
  • Bachelor in Medical Laboratory Techniques from KHL, Leuven in 2000

Training and Certification

  • Entrepreneurial Boot Camp - Antwerp Management School in 2010 Certification

Languages

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

Work Preferences

  • Locations I am interested in:
    Brussels, Belgium Flanders, Belgium
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Antwerp, Belgium

Others

Driving License
  • Yes