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.
Senior Scientist - Vaccines Clinical Laboratory ScienceBelgium
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
clinical scientist in immuno-oncologyApril 2013 --- April 2015
Scientist Technical Regulatory AffairsNovember 2010 --- April 2013
Research associateDecember 2009 --- August 2010
Postdoctoral fellowMay 2005 --- May 2010
PhD studentJanuary 1999 --- January 2004
FlexibilityOptimismProactivityProblem solvingResult OrientedStrategic thinkingSociabilityResiliencyIndependenceCoordinationCollaboration
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