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Summary

Medical Doctor (MD, 2001), clinical pharmacologist (phd, 2010, ghent University). contractor (via cmast bvba) to janssen Research & development (a division of janssen pharmaceutica nv) -beerse (belgium)  & Visiting professor of Medicine - Clinical pharmacology and therapeutics, ghent University.

  • expertise:
    • clinical Drug Development including: 
      • working with cros, kols, and regulatory bodies.
      • Clinical trials end-to-end workflow: 
        • pre-trial activities (trial design, trial synopsis, science)" >Protocol development and review, ibs, (e)crfs, trial related questions from iecs/irbs), 
        • during-trial activities (medical monitoring / oversight, safety /clinical/efficacy listings review, ad-hoc interactions with investigators/sites) and,
        • post-trial activities (aes/saes review, trial results reporting).
    • Healthcare data Sciences and real world data/evidence (rwd/rwe) Analytics
    • semantics in Healthcare: semantic etl, terminology mappings, medical vocabulary/ontologies, clinical decision support systems, knowledge representation, reasoning, n3 rules and nlp.
  • (inter)personal skills: can-do-attitude - proactive - organization -project managment -eye to details- team player - integrity - advanced computer literacy

Experiences

Current Experience

  • Contractor (via CMAST bvba)

    Beerse, Belgium
    Since September 2017
    • Senior Clinical researcher (Janssen Clinical Innovations -JCI): various projects -mainly innovative clinical trial solutions, cross therapeutic areas.
    • Data scientist (Hospital Network -RWD/RWE analyst)

  • Visiting Professor - Clinical Pharmacology


    Since October 2015
    -academic activities : thesis supervision, Teaching -Clinical research in Clinical pharmacology -Academic activities : Thesis supervision, Teaching -Clinical Research in Clinical Pharmacology

Past Experience

  • Senior Development Lead (Medical)

    October 2016 --- August 2017
    • responsible for 2 proof-of-concept studies for new indications for a leading compound portfolio.
      activities includes:
      • pre-trial activities (trial design, trial synopsis, science)" rel="nofollow">Protocol development and review, ibs, (e)crfs, icfs and trial related questions from iecs/irbs),
      • during-trial activities (medical monitoring / oversight, safety /Clinical/efficacy listings review, ad-hoc interactions with investigators/sites) and
      • post-trial activities (aes/saes review, trial results reporting).
      • interaction with pv teams
      • Medical writing.
      • working with (in) cros, kols, and regulatory bodies.
      • Drug Safety oversight (aes/sae/susar adjudication and reporting).

  • Senior Clinical Researcher (Medical)

    January 2013 --- September 2016

  • Post-Doctoral researcher (Clinical Pharmacology -Access to medicines)

    June 2010 --- December 2012
    accessing medicines in africa and south asia (amasa) is a 3-year Research project funded under the European Union's framework programme 7. it is led by the University of edinburgh, in collaboration with partners in belgium, switzerland, uganda, south africa and india. the Research investigates how the interplay of patent regimes, Pharmaceutical regulation, availability of drug production facilities, Health Care infrastructure, service provision, and engagement by foreign donors influence appropriate, affordable access to medicines. the project examines the production, distribution, supply and consumption of medicines within seven Health Care areas – hiv/aids, malaria, reproductive health, tuberculosis (tb) control, mental health, pain management and Diabetes. my role as site Coordinator included scientific lead and coordination, management activities both staff and budget.

  • Study physician (Investigator)

    July 2007 --- June 2010

    the drug Research unit ghent (d.r.u.g) was at that time an academic Hospital based CRO conducting early phase (fih - ia,b and iia) Clinical trials and supporting pharma & biotech companies on different aspects/Phases of clinical development. my role was Investigator. references: http://www.drug-uzgent.be

  • PhD Reseacher (Clinical Pharmacology)

    September 2005 --- May 2010
    Clinical pharmacology Research activities (combined with phd studies)

  • Lecturer

    February 2004 --- September 2006
    Teaching and other academic activities. Research

  • Hospital Medical Doctor (Internal Medicine Department)

    June 2001 --- June 2006

Personality

Self Assessment :
Attention to detailOptimismProactivityProblem solvingResult Oriented

Knowledge

Self Assessment :
Scientific writingAdverse Events (AE)Clinical DevelopmentClinical monitoringClinical pharmacologyClinical researchClinical Study DesignClinical trialsCRF designDeveloping Clinical Trial ProtocolsDrug DevelopmentEarly development stageGeneral MedicineGeneral practiceGood Clinical Practice (GCP)HospitalsICH guidelinesInternal medicineKOL managementPharmacodynamicsPharmacokineticsPhases of clinical development (phase I to IV)Presentation SkillsProblem SolvingStudy protocolsRear-world data (RWD)Real-World Evidence (RWE)Data Analysis
LinkedIn Assessment :
Clinical pharmacologyBiostatisticsPhysicianEpidemiology studiesMedicinepharmacologyMedical EducationStatisticsCardiovascular researchBiomedical InformaticsSemantic WebOverall managementHealthcareResearchPublic HealthLife SciencesscienceProject ManagementTeam ManagementProject LeadershipClinical researchClinical trialsEpidemiology

Skills and Expertise

Self Assessment :
Analytical skills Build and manage the Trial Master File (TMF) Develop clinical trial protocols Interact with physicians Interact with nurses Monitor a clinical study Search literature on clinical trials Write protocolsAct as the main line of communication between the sponsor and the investigatorAttend investigator meetingCollaborate with principal investigatorCommunicate with investigatorCommunicate with sponsorDesign clinical trialDesign inclusion criteriaDesign exclusion criteriaDesign protocolsEnsure good clinical practice (GCP)Evaluate post-marketing surveillance studyEvaluate protocolsInitiate clinical trials Interact with CROsInteract with KOLInteract with physiciansLiaise with doctors and other professionals throughout the studyLiaise with professionals in other divisions of the company as requiredManage clinical trial files/documentsManuscript preparation and reviewMonitoring enrolmentParticipate in medical reviewPre-study procedures Planning clinical studiesPrepare final reportProvide medical rationale of diseaseRead medical literature to maintain current awareness and knowledgeReport serious adverse events (SAE)Resolves queriesSerious Adverse Event (SAE) ReconciliationSupervise PhD studentsTranslate clinical research concepts into specific objectivesTranslate customer needs into analytical study proposal/protocolUnderstand protocols

Education

  • PhD in Clinical Pharmacology from Ghent University in 2010
  • Training Certificate in Biostatistics & Applied Informatics from Université libre de Bruxelles in 2004
  • University Diploma in Epidemiology from Université de Bordeaux in 2004
  • MD in Medicine from School of medicine, National University of Rwanda in 2001

Training and Certification

  • Good Clinical Practice (GCP) in 0000 Certification
  • Good Clinical Practice (ICH/GCP) & FDA Updates in 0000 Certification

Languages

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

Work Preferences

  • Positions I am interested in:
    Clinical Development Consultant Biomedical Scientist Clinical Director Clinical Research Consultant Clinical Research Coordinator Clinical Research Physician Clinical Trial Specialist (CTS) Doctor Drug Safety Officer Field Clinical Specialist MD (Medical Doctor) Medical Director Medical Officer Scientific Advisor Senior Medical Writer Real-World Data (RWD) analytics Real-World Evidence (RWE) Data Scientist
  • Positions I am NOT interested in:
    Galapagos Galapagos NV
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Oudenaarde, Belgium

Others

Driving License
  • Yes

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