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Medical Doctor (MD, 2001), Clinical Pharmacologist (PhD, 2010, Ghent University). Senior development lead (Medical Monitor) at Galapagos NV & Visiting professor of Medicine - Clinical Pharmacology and Therapeutics, Ghent University.

  • Expertise:
    • Clinical drug development (phase I to IV) end-to-end workflow.
    • Drug safety and post-trial activities (AEs/SAEs review, trial results reporting).
    • Working with(in) CROs, KOLs, and regulatory bodies.
  • (Inter)Personal skills: Can-do-attitude - Proactive - Organization- Team player - Integrity - Advanced Computer literacy


Current Experience

  • Senior Development Lead (Medical)
    Since October 2016

    • Responsible for 2 Proof-of-Concept studies for new indications for a leading compound portfolio.
      Activities includes:
      • pre-trial activities (trial design, trial synopsis, 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).

  • Visiting Professor - Clinical Pharmacology
    Since October 2015
    -Academic activities : Thesis supervision, Teaching -Clinical Research in Clinical Pharmacology

Past Experience

  • 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:

  • 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

    • Hospital clinical activities in internal medicine
    • Academic activities: Teaching, bed-side teaching, Dissertations supervising
    • Research activities: Principal investigator /Promoter of various research project in Internal medicine, infectious diseases and cardiovascular field but also in other fields.


Self Assessment :
Attention to detailOptimismProactivityProblem solvingResult Oriented


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 protocols
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


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


BrightOwl Assessment:
Self Assessment:
Full Proficiency
Professional Proficiency

Work Preferences

  • Notice Period:
    1 week
  • 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
  • Positions I am NOT interested in:
    Galapagos Galapagos NV
  • Work From Home:
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl freelancer :    20 Hours per week :    100 Free Per Month(in coming months)
    BrightOwl employee :    100% FTE
  • International:

Area / Region

Oudenaarde, Belgium


Driving License
  • Yes