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Summary

dr. dr. beelke has worked in Clinical research for more than 18 years, including 7 years within academic research in Neurology and sleep Medicine. he authored more than 35 peer-reviewed articles, was in charge as peer-Reviewer for several Publications, designed more than 30 Clinical trials, reviewed more than 300 Study proposals, and has chaired and spoken at numerous conferences in the field of sleep Medicine, multiple sclerosis and life-cycle management. he began his Career within the Pharmaceutical Industry in Clinical Development within schering spa (italy) as Clinical Trial Leader CNS, became shortly thereafter Project Manager Diagnostic imaging & CNS. he led, thereafter, the Health Economics and outcome research unit, building up this unit for all Therapeutic Areas. after 3 years he joint serono sa headquater in geneva in the position of Medical Director Neurology within the global Clinical Development unit, guiding the development of medical scientific strategies. after the acquisition by merck he moved into early development as global head of poc Strategy liaison Neurology, within the exploratory Medicine department. during this time period, he set up the poc unit, led the development of consolidated Biomarker plans within Neurology, anticipated clinical needs within the early development plan, drove the development of an integrated experimental platform and Biological database, with the objective of a faster and more cost-effective selection of candidates for the full Clinical Development. he hold thereafter the position as director medical affairs within merck serono within the bu neurodegenerative diseases & Rheumatology. dr. dr. beelke holds an MD (University of genoa, italy), and a phd in sleep Medicine (University of bologna, italy), received Training with board certification as clinical neurophysiologist (University of genoa, italy), and a board certification as Expert in sleep Medicine from the italian society for sleep Medicine (aims).

Experiences

Current Experience

  • Member of the Editorial Board


    Since August 2016
    journal of Health and social Sciences (issn 2499-2240 e-issn 2499-5886) is a peer-reviewed, open access journal that is published three times per year in march, july and november. this is the scientific journal of the italian society for psychotherapy and social development (sipiss). sipiss – società italiana di psicoterapia integrata per lo sviluppo sociale (italian society for psychotherapy and social development) – is a scientific association for the Research in Medicine and social Sciences. we are a network of professional and amateur scientists from diverse disciplines that provides support and a forum for international Research and Education. Journal of Health and Social Sciences (ISSN 2499-2240 e-ISSN 2499-5886) is a peer-reviewed, open access journal that is published three times per year in March, July and November. This is the scientific journal of the Italian Society for Psychotherapy and Social Development (SIPISS). Sipiss – Società Italiana di Psicoterapia Integrata per lo Sviluppo Sociale (Italian Society for Psychotherapy and Social Development) – is a scientific association for the research in medicine and social sciences. We are a network of professional and amateur scientists from diverse disciplines that provides support and a forum for international research and education.

  • Member of the Editorial Board


    Since May 2015
    multiple sclerosis and demyelinating disorders will publish high-quality, original, basic, and Clinical research in the field of multiple sclerosis, neuromyelitis optica and all other demyelinating diseases of the Central nervous system. main areas of interest include: Biochemistry, Epidemiology, Genetics, Health services research, molecular biology, neuroimaging, neuroimmunology, Neurology, neuropathology, neuropsychology, neurorehabilitation, pharmacology, Physiology, political science, Protein Chemistry, Psychiatry, public Policy, sociology, and therapeutics. the journal also focuses on areas of research underrepresented in the existing literature, such as the Economics and sustainability of multiple sclerosis clinical care, the role of advanced Nursing on clinical care of demyelinating disorders, and the impact of stakeholder’s associations on the management of multiple sclerosis. c/o biomed central http://www.msddjournal.com/ Multiple Sclerosis and Demyelinating Disorders will publish high-quality, original, basic, and clinical research in the field of multiple sclerosis, neuromyelitis optica and all other demyelinating diseases of the central nervous system. Main areas of interest include: biochemistry, epidemiology, genetics, health services research, molecular biology, neuroimaging, neuroimmunology, neurology, neuropathology, neuropsychology, neurorehabilitation, pharmacology, physiology, political science, protein chemistry, psychiatry, public policy, sociology, and therapeutics. The Journal also focuses on areas of research underrepresented in the existing literature, such as the economics and sustainability of multiple sclerosis clinical care, the role of advanced nursing on clinical care of demyelinating disorders, and the impact of stakeholder’s associations on the management of multiple sclerosis. c/o BioMed Central http://www.msddjournal.com/

  • Medical Director


    Since January 2015
    • global lead medical monitor for Phase I, ii and iii trials on Treatment of behavioral variant frontotemporal dementia, alzheimer’s disease, multiple sclerosis, multiple system atrophy, duchenne’s muscular dystrophy, mixed depression, acromegaly and lymphorea • regional medical monitor in a post authorisation safety study (pass) for smoke cessation • execution of sae related medical review • providing therapeutic and science)" rel="nofollow">Protocol-specific Training to the project teams • contributing medical and strategic input into the design of Clinical Development programs, study protocols, Research papers, client focused white papers, etc • supporting Business Development through participation in proposal generation, feasibility assessments, review of proposals/contracts for medical services, and attendance at meetings with sponsors • reviewing and/or assisting in the preparation of final study reports (csrs), or other study Documentation (protocols, iss/ises etc) • identifying, documenting and appropriately resolving out-of-scope work • mentoring of other medical staff (nurses, junior physicians, etc) • supporting senior management’s Leadership of both the department and the company • Global Lead Medical Monitor for Phase I, II and III trials on treatment of behavioral variant Frontotemporal Dementia, Alzheimer’s disease, Multiple Sclerosis, Multiple System Atrophy, Duchenne’s muscular dystrophy, mixed depression, Acromegaly and Lymphorea • Regional Medical Monitor in a Post Authorisation Safety Study (PASS) for smoke cessation • Execution of SAE related medical review • Providing therapeutic and protocol-specific training to the project teams • Contributing medical and strategic input into the design of clinical development programs, study protocols, research papers, client focused white papers, etc • Supporting Business Development through participation in proposal generation, feasibility assessments, review of proposals/contracts for medical services, and attendance at meetings with sponsors • Reviewing and/or assisting in the preparation of final study reports (CSRs), or other study documentation (Protocols, ISS/ISEs etc) • Identifying, documenting and appropriately resolving out-of-scope work • Mentoring of other medical staff (nurses, junior physicians, etc) • Supporting Senior Management’s leadership of both the department and the company

Past Experience

  • Director Medical Monitoring

    July 2012 --- December 2014
    • global lead medical monitor for Phase I, ii and iii trials on Treatment of behavioral variant frontotemporal dementia, alzheimer’s disease, multiple sclerosis, multiple system atrophy, duchenne’s muscular dystrophy, mixed depression, acromegaly and lymphorea • regional medical monitor in a post authorisation safety study (pass) for smoke cessation • execution of sae related medical review • providing therapeutic and science)" rel="nofollow">Protocol-specific Training to the project teams • contributing medical and strategic input into the design of Clinical Development programs, study protocols, Research papers, client focused white papers, etc • supporting Business Development through participation in proposal generation, feasibility assessments, review of proposals/contracts for medical services, and attendance at meetings with sponsors • reviewing and/or assisting in the preparation of final study reports (csrs), or other study Documentation (protocols, iss/ises etc) • identifying, documenting and appropriately resolving out-of-scope work • mentoring of other medical staff (nurses, junior physicians, etc) • supporting senior management’s Leadership of both the department and the company

  • Director Medical Affairs Neurology

    September 2009 --- May 2012
    • contributing to build up the medical affairs unit, which was previously lacking (some activities were coordinated by the global Clinical Development unit, some others by Marketing) • guiding the establishment of a site stratification process and a differentiation of clinical studies sponsored within medical affairs (local and regional studies). • contributing to guide the integration of country specific medical affairs plans into global and regional medical affairs plans. • contributing to raise the scientific quality of medical initiatives across regions (eu, intercontinental, asia-pacific and latin-america) through internal Training and direct scientific support of local and regional strategies. • successful increase of quantity and quality of the scientific Study proposals from emergent markets. • contributing to foster relationships to relevant external experts through a scientifically driven interaction. • contributing in the development of new internal processes for regional studies. • designing and guiding scientifically the first globally coordinated, and regionally managed add-on study of vitamin d on top of rebif 44.

  • Medical Director

    October 2007 --- August 2009
    head of poc Strategy liaison unit Neurology to bring lead compounds from Discovery to Clinical Development. selection of most relevant therapeutic indication and Strategy for go/ no-go decision to full Clinical Development. • set up of the new poc unit which was previously lacking, to allow bridging between pre-Clinical Development and full Clinical Development, and a faster decision making process, and cost savings due to more selective screening of clinically relevant and developable compounds. • guidance in the development of biomarkerplans for each compound in the pipeline for the therapeutic area Neurology to insure an integrated Analysis of translational and Biomarker Research for the clinical Product Development, focused on the scientific unmeet needs and the business relevance. • raising the quality of early development plan by anticipating issues for the Clinical Development and answering of open questions before the design of poc studies. • driving the clinical indications review to identify early Business Development opportunities • driving the development of strategies to bridge earlier indications coming from Therapeutic Areas and projects into clinically applied technologies through an experimental platform and a common Biological data base including Genetics, Genomics and imaging. • contributing to design the Clinical Development plan for pegylated and slow release ifn beta-1a • designing the Clinical Development plan for apitope, an immunotolerance Treatment for multiple sclerosis.

  • Medical Director

    January 2007 --- September 2007
    • contributing in both, Clinical and Business Development strategies for rebif and cladribine. • identifying risks within the clarity study, and guided a multifunctional team to solve them. • successful speed up of recruitment for the clarity study, and to complete it. • design of the improve study, i guided the design of the reflex study, and i contributed in the design of the atacicept poc study. i ameliorated the study design of the clarity study. • contributing in identification and evaluation of business opportunities considering all industry market trends in Neurology.

  • Medical Director

    February 2006 --- December 2006
    consultancy and Training within Pharmaceutical Industry, Health Care system and Research • contributing in both, Clinical and Business Development strategies for rebif and cladribine. • identifying risks within the clarity study, and guided a multifunctional team to solve them. • successful speed up of recruitment for the clarity study, and to complete it. • design of the improve study, i guided the design of the reflex study, and i contributed in the design of the atacicept poc study. i ameliorated the study design of the clarity study. • contributing in identification and evaluation of business opportunities considering all industry market trends in Neurology.

  • Health Economics and Outcome Research Manager

    January 2005 --- January 2006
    Health Economics and outcome reserach manager for the whole schering portfolio as national representative for italy in a global team • set up of the Health Economics & outcome Research unit for italy. • developing Health Economics and outcome Research strategies for all Therapeutic Areas (7 projects within one year, at least one per therapeutic area). • driving Reimbursement support and health economic modeling based on patient reported outcomes (pro) and other outcomes • contributing in the development of Reimbursement dossiers, and price Negotiation. • contributing in the development of Global Health economics & outcome Research strategies (starting from Phase II up to Phase IV studies) as big 5eu Member of the global core team.

  • Project Manager Diagnostic Imaging & CNS Unit

    October 2003 --- January 2005
    working in Clinical Development and medical affairs • guiding the site stratification process to differentiate the medical affairs strategy in relation to the medical scientific needs of the different multiple sclerosis centers. • successful scientific differentiation of schering spa’s image as scientific driven company from competitors through the differential design of 12 studies (Phase II, iii, iv and observational studies) in patients with multiple sclerosis for national use. • selection among Investigator initiated studies proposals the strategically most relevant, for financial support • guiding kol management in italy and being the primary contact person for the headquarter for the most relevant kols. • Training of Sales forces and successful better differentiation of betaferon from competitors through higher quality of scientific knowledge of the Sales forces and better rapports to the experts in multiple sclerosis. • contribution in Planning of national Marketing Strategy and the development of national Communication strategies.

  • Clinical Trial Manager (CTM)

    May 2003 --- January 2005
    • international Clinical trials in ms • managing the international studies benefit and beyond on a country level (Phase III studies), and betaplus and bright (observational studies).

  • Clinical and Research Experience in Clinical Neurophysiology

    October 1996 --- October 2003
    Research in sleep Medicine • focus of scientific Research: - epilepsy, microstructure of sleep, narcolepsy, fatal familiar insomnia, obstructive sleep apnoe, periodic limb movements during sleep, restless legs syndrome - more than 30 peer-reviewed Publications in int. journals • Teaching experience as Expert in sleep Medicine for the professional Training of technicians in Clinical neurophysiology (1997-2003), students in Medicine (1999-2003) and post-graduates in Clinical neurophysiology (1999-2003) • ultrasound recordings and Clinical reporting • recording and Clinical reporting of eeg and video-eeg • eng and emg recordings and Clinical reporting • neurological outpatient’s department • outpatient’s department for sleep Medicine • polysomnografic recordings and Clinical reporting (since1996) • outpatient’s department for headache • outpatient’s department for mnesic deficits

Knowledge

Self Assessment :
NegotiationMarket accessMedical DevicesMedical consultingMedical ImagingMedical writingMicrosoft ExcelMicrosoft OfficeNeuroscienceNew Drug Application (NDA)Outcome Measurement Study (OMS) Patient Follow UpPatient Reported Outcome Measures (PROMs)Patient Screening and Recruitmentpeople managementPharmaceutical IndustryPharmacodynamicsPharmacogeneticsPharmacogenomics (study of genetic variation)PharmacokineticsPharmacovigilancePhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)Informed Consent DocumentsUnderstanding of regulatory guidelinesUnderstand levels of research evidenceUnderstand how results translate to practiceTroubleshootingStrategic PlanningStudy outcomes and outcome measuresStatistical considerations in design and analysisTeam LeadershipMedical affairsMedical budget managementPowerPointPre-clinical researchFDAGCPPreventative medicineProcess improvementRandomization and blindingRandomization SystemsRegulatory RequirementsRegulatory Strategies Lab scale batchesSerious Adverse Event (SAE)SOPScientific methodologySchizophreniaSafety trialsScreen patientsEMAEnglishEthics submission and approval processProblem-solving methods and troubleshootingPrinciples and ethics of clinical researchProtocolPsychiatryQuality of Life (QoL) outcomesR&DNeurology Biostatistics Medical devices Phase I R&D Scientific writing Animal modelsActions and modes of action of drugs in the human speciesAntibodiesBiological Drug DevelopmentBiopharmaceuticalsBiotechnologyCancerCAPAClinical DevelopmentClinical monitoringClinical researchClinical Study DesignClinical study reportsClinical trial audits and inspectionsClinical trial budgetingClinical trial designClinical trial managementClinical trialsCommunication SkillsData ManagementDiagnostic radiologyDiagnosticsDrug development processDrug InteractionDrug metabolismDrug regulatory authoritiesDrug Safety and PharmacovigilanceDrug safety assessmentDrug substance developmentEndocrinologyGenetic polymorphismGeneticsGermanGood Clinical Practice (GCP)Good Publication Practice (GPP)HospitalsICH GCP guidelinesICH-GCPImmunologyInflammationInformed Consent ProcessInterpret clinical trial resultsInterpret clinical trial resultsInterpret systematic reviewsKnowledge of the drug development processKOL management
LinkedIn Assessment :
NeurologyClinical trialsClinical researchPharmaceuticalsBiotechnologyHealth EconomicsSleep MedicineMultiple sclerosisKOL managementPeople Management.Medical DirectorsNon Clinical ResearchStatisticsMarket accessMedical CommunicationsMedical affairsPost-marketing StudiesFull Clinical DevelopmentEarly Clinical DevelopmentMarketingBig EU5Emerging MarketsInternal and external trainingParkinson DiseaseClinical DevelopmentPharmaceutical IndustryDrug DevelopmentAlzheimer's diseaseFrontotemporal DementiaSmoking CessationMixed DepressionHypomaniaRegulatory submissionsPharmacovigilanceBiomarkersClinical Study DesignCROClinical pharmacologyCTMSmanagementoncologyMedical writingClinical monitoringGCPDiabetesICH-GCPTherapeutic Areas

Skills and Expertise

Self Assessment :
Design post-marketing surveillance studyEvaluate protocolsEvaluate post-marketing surveillance studyManage publication strategy of clinical trial results Develop clinical trial protocols Assure medical quality Control data Interact with nurses Interact with physicians Interpret data Monitor a clinical study Write papers Create SOPsAlzheimerAssess adverse reactionsAssess site feasibilityApprove patient informationAdjust methodsBiomarker ResearchAttend steering committeea Search literature on clinical trialsAdvise on medical perspectivesAdverse event reportingAnalyze data Receptor PharmacologyCoachCoach clinical staffCoach staffCollaborate with principal investigatorCollaborate with project teamCommunicate with investigatorCommunicate with sponsorComplete case report form (CRF)Conduct literature searchesConduct post-marketing surveillance studyConduct research at universitiesConduct site initiationConduct the trialConduct university research Confirm protocol complianceConsequences analyses of trial designCollaborate with medical teamAssess subject safetyAttend investigator meetingAssure medical qualityAttend seminarsbudgeting of R&D activitiesBuild trial master file (TMF)Data analysisCreates a collaborative team environmentCreate study documentsDevelop clinical trial protocolsDevelop clinical strategyDevelop clinical hypothesesInteract with CROsInteract with ethics committeeInteract with nursesInteract with pharmacistsInteract with physiciansInteract with pre-clinical scientistsWrite papersWrite protocolsWritten presentationWrite combined statistical and medical reportsWrite clinical evaluation reportswrite and maintain clinical evaluation reportsUse content management systems Report dataDesign exclusion criteriaDesign inclusion criteriaDesign information leafletEnsure good clinical practice (GCP)Ensure data integrityEstimate subject complianceEnsure data consistencyEthics committee applicationEvaluate licensing opportunities Molecular DiagnosticsInitiation visitIdentify investigatorsIndentify clinicians to conduct clinical trialsInterpret data Build the CMC development planWrite medical reportsTrain off site staffTrain on site staffSupervise trial supplies

Education

  • Specialist in Clinical Neurophysiology from Università degli Studi di Genova in 2003
  • PhD in Sleep Medicine from Università di Bologna in 2002
  • MD in Medicine and Surgery from Università degli Studi di Genova in 1998

Training and Certification

  • Board certified Clinical Neurophysiologist in 0000 Certification
  • Board certified expert in Sleep Medicine in 0000 Certification
  • Board certified general physician and surgeon in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
German
Native
Italian
Full Proficiency
English
Full Proficiency
French
Elementary Proficiency

Area / Region

Gauting, Germany

Others

Driving License
  • Yes

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