Senior Research Scientist
Since April 2014
I moved in 2014 from the pharmaceuticals group to the vaccines group to expand my knowledge of the development of biologicals. I acted as clinical lead for the development of companion animal vaccines in Europe and monitored several OOI and DOI studies. I also supported the EU swine vaccine team in monitoring clinical swine studies. In 2016 I joined the Elanco IACUC as a voting member.
Scientist International R&D
July 2011 --- March 2014
After the acquisition of Janssen Animal Health by Elanco I continued my job as Project Team Leader in the Companion Animal Product Development Team for several projects. I was also responsible for the Elanco cat colony housed at the University in Ghent. I participated as a member of the Elanco Ethical Review Board and was involved in the writing of scientific publications.
Scientist International R&D
September 2006 --- June 2011
I started as a study director for in-house animal studies and as a study monitor for outsourced safety trials (GLP) and field trials (GCP) in US en EU. I gained expertise in writing protocols and reports, negotiating contracts and managing study budgets. I was a member of several project teams as well as the project lead for 2 projects. I gave support to the regulatory department by compiling dossiers for FDA and EMA. Also SOP writing was part of my job. Moreover, I was also responsible for the Janssen Animal Health dog and cat colony.
Veterinarian, PhD student
September 2002 --- July 2006
Preparing a PhD at the departement of Pathology, Bacteriology and Avian diseases.
Analytical thinkingCharmCommunicativeCoordinationEfficiencyFlexibilityKindnessProblem solvingResponsibilitySociabilityTrust
Animal models R&D Scientific writingAnimal HealthBacteriologyBudgetsClinical Data ManagementClinical DevelopmentClinical operationsClinical monitoringClinical researchClinical study reportsClinical Study DesignClinical trial audits and inspectionsClinical trial budgetingClinical trialsClinical trial managementCRODeveloping Clinical Trial ProtocolsDesigning case report formsDrug development processDrug regulatory authoritiesEfficacy trialsElectronic Data Capture (EDC) Ethics submission and approval processGood Clinical Practice Veterinary (GCPv)HistologyInfectious diseasesInformed Consent ProcessKOL managementLaboratory Animal MedicineMedical writingMicrosoft OfficeNew Drug Application (NDA)PathologyPCRPharmaceutical ResearchPhases of clinical development (phase I to IV)Pre-clinical researchPreclinical SafetyProject ManagementQuality Assurance (QA)Quality Control (QC)Regulatory affairsReport WritingSafety trialsScientific WritingStandard Operating Procedure (SOP)Study protocolsTeamworkUnderstanding of regulatory guidelinesVaccinesVeterinary MedicineVirology
Bachelor’s Degree in Graphic Designer from Syntra in 2009
Master in Laboratory Animal Science in Veterinary Medicine from Ghent University in 2006
PhD in Doctor in Veterinary Medicine from Ghent University in 2006
Certificate in Business Economics from University of Antwerp Management School in 2005
Veterinarian in Veterinary Medicine from Ghent University in 2002