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.
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.
Research Associate Mechelen, BelgiumJune 2004 --- August 2010
in support of the internal Infectious diseases development programs:
Strategic thinkingAnalytical thinkingInnovative thinkingResult OrientedEfficiencyProblem solvingAttention to detailCollaborationApproachabilityCommunicativeIndependenceResponsibility
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
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
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