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Summary

with a background of 10-years in academic Research and more than 6-years in the Pharmaceutical Industry, i have developed very strong scientific skills as well as end-to-end expertise in vaccine development. i have a phd in molecular biology/Virology together with five years’ Postdoctoral experience in the development of strategies exploiting Cancer immune defect for oncolytic Virus therapy. i possess extensive knowledge in Virology, Immunology, molecular biology and oncology. since joining gsk, i accumulated 2+ years’ experience in vaccine Regulatory Affairs followed by two years’ experience as Clinical Scientist for the development of immunotherapeutic approaches against Cancer i joined cls as senior scientist in april 2015, where i am in charge of immuno Assay development, Assays Validation and clinical Testing Strategy for rsv and cmv vaccine development. i have excellent analytical, communication and networking skills. i am an ideal candidate for a position requiring Leadership, initiative and Strategy. flexible, adaptable and able to respond efficiently to shifting priorities in a matrix environment, i also possess excellent written and oral Communication Skills in both English and French.

Experiences

Current Experience

  • Senior Scientist - Vaccines Clinical Laboratory Science

    Belgium
    Since April 2015
    Clinical study reports

    As senior scientist, I contribute to the immunological read-out strategy to support RSV and CMV vaccine clinical development programs. I lead design, development, optimization, trouble shooting and validation of clinical assays in agreement to GxP requirements (GMP, GCP, GCLP). My key responsibilities are:

     

    • Set up and oversight of assays required to evaluate GSK Vaccines in clinical programs
    • Assay development and validation
    • Contribute to clinical development plans and clinical study protocols
    • Interpret data for clinical study reports and vaccine formulation selection
    • Act as principal author of regulatory documents ( INDs/CTAs, briefing documents for regulatory consultations, regulatory submissions, Q&A from regulatory authorities, inspections/audit)
    • Provide support for the development and/or review of internal and external publications, documents and communications.
    • Oversight of internal operational activities related to assay development and validation, assay maintenance and clinical testing performed under the responsibility of Scientits and Lab Managers.
    • Scientific and technical oversight of CROs for assay development, validation, transfer and data delivery.
    • Follow up of external collaborations
    • Participate to capacity management and lab operations prioritization; prepare, control and justify OPEX and CAPEX budgets.
    • Ensure all clinical testing activities are performed in compliance with Quality Assurance (QA) guidelines, relevant regulations and internal policies

     

Past Experience

  • clinical scientist in immuno-oncology

    April 2013 --- April 2015
    Biomarker

  • Scientist Technical Regulatory Affairs

    November 2010 --- April 2013
    Clinical Development

  • Research associate

    December 2009 --- August 2010
    Data Analysis

  • Postdoctoral fellow

    May 2005 --- May 2010
    Cancer

  • PhD student

    January 1999 --- January 2004
    Biological

Personality

Self Assessment :
FlexibilityOptimismProactivityProblem solvingResult OrientedStrategic thinkingSociabilityResiliencyIndependenceCoordinationCollaboration

Knowledge

LinkedIn Assessment :
molecular biologyImmunologyVirologyMolecular OncologyRegulatory affairsLifesciencesBiotechnologyVaccinesCancerCell biologyClinical researchDrug DiscoveryIn VitroIn VivoLaboratoryRBiomarkersR&D

Education

  • Bachelor in chemestry/biochemistry from University of Brussels in 0000
  • Master in sciences (molecular biology) from University of Brussels in 0000
  • PhD in molecular virology from University of Brussels in 0000

Languages

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

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    No

Area / Region

Rixensart, Belgium

Others

Driving License
  • Yes

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