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Summary

I am a highly motivated DABT certified toxicological pathologist, toxicologist and project manager with almost 10-years international early stage experience in CRO, pharmaceutical industry and R&D. My expertise represents Phase I risk and toxicological assessments, in the following therapeutic areas: dermatology, ophthalmology, respiratory diseases, carcinogenesis, cardiovascular, irradiation, and medical devices. I work within multidisciplinary matrix environments with strong interpersonal skills in order to lead and evaluate in-house/outsourced safety studies in order to defend Phase I data to EU, US and Japanese regulatory authorities. I am well organized, proactive, self-motivated, efficient, disciplined, committed to life-long learning and effective communicator with a strong work ethic. My leadership experiences are team building, developing others, able to motivate and convince others especially when standing alone.

Experiences

Past Experience

  • Senior Toxicological Pathologist, DVM, DABT
    February 2015 --- April 2016
    NonClinical HistoPathological - Toxicological Assessments within a GLP scientific work practice Investigative Toxicology, Animal Models Therapeutic Areas: Ophthalmology, Neurology, Respiratory, Dermatology, Carcinogenesis Optic/Digital microscopy Regulatory Submissions: Europe, US, Japan Chair Ethical Committee Member Quality Assurance Committee

  • Staff Toxicological Pathologist
    September 2013 --- May 2014
    Toxicological Assessments with HistoPathological Evaluations GLP/non-GLP Validation of Animal Models Radiation Toxicity

  • Principal Pathologist & RD Manager
    November 2011 --- October 2013
    Manager Pathology Department Principal Pathologist Principal Investigator CRO liaison Hiring manager

  • Staff Toxicological Pathologist
    July 2006 --- October 2011
    Scientific work preclinical work practice; GLP, ICH, CFR Part 11/58 Non Clinical Assessments: pathology, regulatory submissions All laboratory animal species, light microscopy, review study protocols Therapeutic areas: ophthalmology, neurology, respiratory, dermatology, inflammation, cardiovascular, carcinogenesis Digital Pathology Leadership to small teams

  • Pathologist, Research Fellow
    June 2005 --- March 2006
    GLP/non-GLP studies, regulatory submissions Investigative Pathology, Toxicology Validation of animal models Electron Microscopy

Personality

Self Assessment :
ProactivityProblem solvingWillingness to compromiseApproachabilityAnalytical thinkingAttention to detailCommunicativeCompetitivenessCritical thinkingEfficiencyFlexibilityResiliencyStrategic thinkingTrust

Knowledge

Self Assessment :
Toxicology Animal modelsAngiogenesisAnimal HealthAnimal ModelsAnimal trialCancerCompliance with regulationsDrug Safety and PharmacovigilanceLaboratory Animal MedicineLaboratory ManagementNanotechnologyPharmacovigilancePreclinical regulations and practicesPrinciples and ethics of clinical researchProblem-solving methods and troubleshootingProject ManagementQA complianceQuality Assurance (QA)Regulatory ComplianceRoot Cause Analysis (RCA)
LinkedIn Assessment :
GLPPathologyToxicologyQAAnimal ModelToxicologieBonnes pratiques de laboratoireCROPathologieModèle animalSciences de la vie

Skills and Expertise

Self Assessment :
Create SOPsArchive documentationArchive study documentsAssess adverse reactionsBiomarker ResearchCollaborate with principal investigatorCollaborate with project teamConduct animal studiesConduct literature searches.Create SOPsCreate study documentsCreate standard operating procedure (SOP)Data entryData validationEthics committee applicationExtrapolate dataFollow-up of internal auditsFollow up training programsFollow-up of external auditsFollow-up of quality assurance activitiesInteract with CROsInteract with KOLInteract with ethics committeeInteract with pre-clinical scientistsInterpret dataInterpret scientific dataOral presentationOrganise meetingsOrganize scientific projects (in biology)Oversee data collectionPlan experimentsPrepare CMC source documents Prepare external auditsPrepare final reportPrepare internal auditsPrepare investigator brochures

Education

  • American Diplomate in Toxicology in Toxicology from American College of Toxicologists in 2015
  • in Internship & Residency in Veterinary - Toxicological Pathology from Universiteit Utrecht in 2005
  • DVM in Dvm from University of Liege in 1997

Training and Certification

  • Project Manager in 2016 Certification
  • American Diplomate in Toxicology in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Full Proficiency
French
Full Proficiency
English
Full Proficiency
German
Professional Proficiency

Work Preferences

  • Notice Period:
    1 week
  • Positions I am interested in:
    Preclinical Project Manager Preclinical Scientist Preclinical Research Manager Associate Scientist
  • Locations I am interested in:
  • Work From Home:
    Yes, 0 to 4 days per week
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Aalst, Belgium

Others

Driving License
  • Yes