profile: Veterinarian, dual-licensed us/belgium with 23 years of experience in Veterinary Medicine, veterinary Pharmaceuticals and international Higher Education. my professional record demonstrates a results-driven commitment to quality, accuracy and timing. excellent intercultural Communication Skills and a strong sense of responsibility allow me to work under pressure in a wide range of professional and interpersonal environments, all the while maintaining a positive and friendly attitude and rapidly adding value for my employer, colleagues and stakeholders.
qualities: highly adaptable and flexible, i am a quick study and easily create relationships based on trust due to my open communication style, honesty, reliability and "win-win" approach.
specialties: Veterinary Medicine, medical and scientific affairs/communication, external relations, international Business Development, Pharmaceutical r&d, Regulatory Affairs, Clinical research, English/French fluency, Public Speaking, Intercultural Communication, project, departmental, kol and Contract Management, negotiations & diplomacy, Training programs and Teaching.
Director, Discovery Research Leuven, BelgiumAugust 2014 --- December 2016
• scouted new Business Development opportunities: drugs, technology and industry partnerships • developed early strategic business plan for successful livestock company spin-out • managed Regulatory Affairs projects with the EMA • recruited and managed key opinion leaders • conducted Clinical research and reporting • peer reviewed and edited scientific articles for “antiviral research” journal • championed phase 1 and 2 horizon 2020 research and Innovation grant Applications
INTERNATIONAL PROGRAMS DIRECTOR Brussels, BelgiumSeptember 2006 --- August 2014
• in charge of international Public Relations and diplomacy • negotiated global partnership contracts and academic program agreements • developed and implemented international recruitment and Marketing Strategy • formulated and enforced University academic and administrative Policy • created a bachelor of life science program with the vub school of Medicine • increased departmental revenue by 250%; generated 50% of the college’s annual revenue • planned, directed and acted as master of ceremonies, Lecturer and Trainer at tri-yearly new Student orientation events
Regulatory Affairs Manager Union, NJ, United StatesJanuary 1997 --- January 2001
• developed regulatory Strategy; submitted and managed regulatory dossiers • in charge of Communication with regulatory authorities (FDA) • managed cross-functional projects • enforced Regulatory Compliance • edited Clinical protocols and reports
TECHNICAL SERVICES VETERINARIAN Fort Worth, TX, United StatesJanuary 1996 --- January 1997
• championed Veterinary medical affairs activities • managed cross-functional projects • submitted and managed regulatory dossiers (FDA, epa, Health canada, pmra) • conducted Clinical research and reporting • co-wrote scientific papers – presented results at am. society of parasitologists conf. • in charge of Pharmacovigilance • provided technical Marketing support • trained the Sales force
AdaptabilityApproachabilityAssertivenessAttention to detailAuthenticityCharmCollaborationCommunicativeCoordinationCritical thinkingCuriosityDependabilityDiligenceEfficiencyFlexibilityIndependenceInterest in knowledgeKindnessOptimismOrganizationProactivityProblem solvingResiliencyResponsibilityResult OrientedSelf-confidenceSelf-disciplineSelf-disclosureSociabilityStrategic thinkingTrustWillingness to compromise
Skills and Expertise
Analytical skills Create SOPs Develop protocols Guide students Interpret data Monitor a clinical study Report data Search literature on clinical trials Write papers Write protocolsAct as the main line of communication between the sponsor and the investigatorAdjust methodsAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAdvise on strategyAnalyze data/information to determine potential relationships.Answer, transfer and handle incoming calls as needed.Assemble regulatory applicationsAssess adverse reactionsAssign activitiesAssist with experimentsAssist with proceduresAssist with site trainingAttend at steering committee meetingsAttend investigator meetingAttend seminarsAttend steering committeebudgeting of R&D activitiesCalculate trial timelinesCapture data on source documentsClinical data collectionCoach and provide guidance to clinical staff.collaborate in research projects at universitiesCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamCollect dataCommunicate effectively on different company levelsCommunicate with investigatorCommunicate with sponsorCommunicationCompile informationConduct animal studiesAdverse event reportingConduct literature searchesConduct studiesContract approvalCoordinate projectsCoordinationCreate SOPsData entryDesign efficiency studyDesign marketing advertismentsDesign protocolDevelop business planDevelop regulatory strategyDevelop training materialsDirect co-workersDirect co-workers to achieve resultDistribute study documentsDistribute trial suppliesEnsure consistency between the protocol and CRFEstablish relationships with Key Opinion LeadersEstablish professional relationships with partnersEvaluate protocolsExecute scientific projectsGenerate regulatory submissions Handle callsGuide staffHandle incidentsGuide studentsGeneral office managementIdentify growth / improvement potentialIdentify market opportunitiesImplement data collection systemInitiate clinical trials Interact with CROsInteract with KOLInteract with pre-clinical scientistsInteract with regulatory stakeholdersInteract with statisticiansInterpret analytical resultsInterpret dataInterpret research resultsInterpret scientific dataLabeling compliance with local regulationsLiaise with professionals in other divisions of the company as requiredlifescienceMaintain strong relationshipsManage complexityManage multiple projectsManage regulatory activitiesManuscript reviewNegotiate protocol details NegotiationNetworkNew indications of marketed drugObtain grantsOffice managementOral presentationOrganise meetingsPeople managementPlan work to meet objectives and deadlinesPrepare final reportPrepare regulatory documentsPreparing referral lettersPresent at steering committeePresent clinical resultsPresent data at congressproject managementPromotional materialsProvide medical insightsProvide technical supportProvide support for scientific and/or technical projectsR&DRead medical literature to maintain current awareness and knowledgeReferral lettersRegulatory documentationRegulatory submissionsReport study conclusionsReview clinical study reportsReview dataReview data interpretationReview protocolsReview reportsSearch literature on clinical trialsSet up a clinical studySite managementSolve problemsSubmit regulatory applicationsTeachingTrain StaffUnderstand protocolsWork collaboratively with the other members of the clinical research team Work under specific instructionsWork cross-functionallyWork with coordination and data management teamsWrite clinical evaluation reportsWrite documentsWrite final reportsWrite papersWriting regulatory documentsWritten presentation
Docteur en Médécine Vétérinaire in Veterinary Medicine from Université de Liège in 2004
DOCTOR in VETERINARY MEDICINE from University of Tennessee, College of Veterinary Medicine in 1993
BACHELOR OF SCIENCE in General Biology from Vanderbilt University in 1989
Training and Certification
PTI Training Course: Regulatory Affairs for Veterinary Medicine in 2014 Training
OIE/IICAB Training Course: Veterinary Biologics in 2015 Certification
Training course: 21 CFR Part 11, AWA, Proper Handling of Clin. Mat., Ad. & Prom. Mat., Ad. & Trademark Law, FDA Inspection, Clin. Research, GLP, GCP, Conducting AH Studies for Reg. Compliance in 1997 Certification