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Summary

i believe in ''we'': learn from, transfer to and work with others to translate ideas to actions and actions to innovations

Experiences

Current Experience

  • Clinical Readouts Team leader for MMR/V and Zoster


    Since March 2014
    i am the central point of contact for different bodies within gsk as well as with external collaborators/stakeholders when discussions are related to clinical readouts, vaccine immunogenicity and correlates of protection. i ensure the scientific and clinical relevance of the clinical Immunology Testing to document the immunogenicity of the vaccine and identify correlates of protection. i develop Testing strategies taking into account of the scientific relevance, the technical feasibility and regulatory requirements. i lead the clinical readout team, composed of Assay development experts, Clinical Development managers and regulatory authority experts to ensure alignement within the project and achieve project milestones. I am the central point of contact for different bodies within GSK as well as with external collaborators/stakeholders when discussions are related to Clinical Readouts, vaccine immunogenicity and correlates of protection. I ensure the scientific and clinical relevance of the clinical immunology testing to document the immunogenicity of the vaccine and identify correlates of protection. I develop testing strategies taking into account of the scientific relevance, the technical feasibility and regulatory requirements. I lead the Clinical Readout Team, composed of assay development experts, clinical development managers and regulatory authority experts to ensure alignement within the project and achieve project milestones.

Past Experience

  • Manager Global Regulatory Affairs

    October 2013 --- February 2014
    i provide clinical regulatory guidance to decision bodies and teams to ensure integration of regulatory requirements in the Clinical Development of the vaccine and to ensure alignment of regulatory requirements across projects (seasonal influenza Vaccines). i am responsible for authoring documents for global regulatory submissions (e.g. clinical overview and summaries, pre-cta/ pre-nds briefing documents,) and for company use (global regulatory plans)

  • Clinical regulatory affair scientist

    November 2009 --- September 2013
    i provide clinical regulatory guidance to decision bodies and teams to ensure integration of regulatory requirements in the Clinical Development of the vaccine and to ensure alignment of regulatory requirements across projects (seasonal influenza Vaccines). i am responsible for authoring documents for global regulatory submissions (e.g. clinical overview and summaries, pre-cta/ pre-nds briefing documents,) and for company use (global regulatory plans)

Personality

Self Assessment :
Analytical thinkingCollaborationCommunicativeCoordinationIndependenceOrganizationResult OrientedSelf-disciplineTrust

Knowledge

Self Assessment :
Biochemistry R&DAnalytical techniquesBiological Drug DevelopmentClinical DevelopmentClinical researchClinical study reportsClinical trial designClinical trialsCross-functional team leadershipeCTDEnglishCMCImmunoassaysPhases of clinical development (phase I to IV)Project ManagementRegulatory affairsRegulatory submissionsTeamworkVaccines
LinkedIn Assessment :
Regulatory affairsClinical DevelopmentMatrix ManagementClinical researchRegulatory submissionsPharmaceutical IndustryVaccinesInfluenzaClinical Study DesignClinical trialsProtocol ReviewICH-GCPImmunologieExigences rBiotechnologieBonnes pratiques cliniquesDSOPMaladies infectieuses

Skills and Expertise

Self Assessment :
Collaborate with project teamCommunicationcoordinating research projectsCoordinationInteract with pre-clinical scientistsInteract with regulatory stakeholdersInteract with statisticiansLiaise with research teamManage multiple projectsManage regulatory activitiesManage research projectsPrepare regulatory documentsproject managementProvide input to process improvement initiativesProvide support for scientific and/or technical projectsR&DRegulatory submissionsReview clinical study reportsReview dataReview study protocolsReview the interpretation of dataSolve problemsWork collaboratively with the other members of the clinical research team Work cross-functionallyWrite documentsWriting regulatory documents

Education

  • PhD in Biochemistry and Biophysics from Faculté universitaire des Sciences agronomiques de Gembloux in 2007
  • M2R in Biology, Health, Biotechnology from Université Paul Sabatier (Toulouse III) in 2003

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency
Dutch
Elementary Proficiency
Spanish
Elementary Proficiency

Publications

    Expert has 3 publications (Will be avalible with full profile)

Area / Region

Ramillies, Belgium

Others

Driving License
  • Yes

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