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
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
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
as Clinical Scientist, i developed translational Biomarker studies in order to identify characteristic of the tumor microenvironment responsible for inhibition of tumor immune infiltration. i also developed non-interventional Biomarker studies in order to enable clinical portfolio of new indications and development of companion diagnosis test. my responsibilities included:
- management of Clinical research studies investigating Biomarkers expression in various Cancer indications in order to develop a clinical portfolio of new indications for late clinical Product Development
- handling coordination between principal investigators, clinical teams, external Testing labs, biobanks, hbsm management, Procurement, legal and stat/Bioinformatics in order to deliver quality data within reliable time frame and costs
- responsible for study design, Testing Strategy, Data Analysis, study reports and results presentation
- consultation with kols in order to understand standard of care and define the best protocols and objectives for late Clinical Development portfolio of indications.
i have also been involved in the development of new strategies for gsk next generation of Cancer immunotherapies, integrating aspects such as modulation of the tumor microenvironment, tumor targeting, systemic immune modulation, vaccine platform selection, choice of indications, Clinical Development setting, Validation of relevant pre-clinical models and external collaborations.
Scientist Technical Regulatory AffairsNovember 2010 --- April 2013
- preparation, consolidation and submission of regulatory documents.
- develop and maintain fruitful relationship with r&d, Clinical Development team, Manufacturing, qc, qa and Project Management.
- obtain in due course the data/results/documents, evaluate the quality and present them in files for submissions to regulatory authorities.
- ensure Product Development is in line with regulatory submission Strategy, proactively identify potential problems, and if necessary, prepare scientific as well as regulatory solutions.
- prepare replies in response to questions from regulatory authorities such as FDA, EMA, who, jnda, sfda or national authorities on the regulatory documents submitted.
- prepare briefing documents for scientific advises with authorities.
- master pharmacopoeia and official “guidelines” (general and specific) published by regulatory authorities in order to provide guidance to the concerned gsk departments involved in vaccine development.
Research associateDecember 2009 --- August 2010
dr hiscott’s Laboratory addresses three broad areas of investigation:
- analysis of the immune response to viral infection
- analysis of viral evasion mechanisms and establishment of innovative strategies to block viral spread
my project research focused on the development of combination therapies with oncolytic viruses as new strategies for Cancer Treatment. in particular, i have been studying the potential of deacetylase inhibitors in enhancing the efficacy and specificity of oncolytic viruses. as Research associate, i managed a group of people (phd students, technicians, postdocs) working on different projects such as combination therapies with oncolytic viruses, activation of the innate immune response and hcv viral evasion mechanisms. my responsibilities were:
- design of new and innovative research projects
- perform experiments for the development of these projects
- organize the work of the team in order to achieve higher efficiency
- manage budget (grants, salary, research costs)
- ensure Training of all team members
- Data Analysis, discussion of results
- establishment of scientific collaborations
- writing and reviewing manuscripts for publication and thesis
- introduction of grant Applications
- international conferences participation and presentation
- publication of scientific reviews
my project research was funded by the frsq (fonds de la recherche en sante du québec) and by the ncic (national Cancer institute of canada). my work has been published in pnas (proceedings of the national academy of Sciences).
Postdoctoral fellowMay 2005 --- May 2010
development of anti-Cancer combination therapies with oncolytic viruses and epigenetic drugs.
PhD studentJanuary 1999 --- January 2004
during my phd. i studied the transcriptional regulation of retroviruses (blv, htlv-i and hiv), focusing on the role of epigenetic modifications of the chromatin structure and post-translational modifications (acetylation and phosphorylation) of the tax/tat trans-activators.
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