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Summary

roberto martinez neira is passionate about the human condition, professes empathy for others and exerts a strong willingness to help, which drives him to join the dots, to integrate many different areas of knowledge and to produce game changing solutions with the goal of enabling affordable quality Healthcare, and a cleaner, healthier environment for all.
roberto was born and raised in his much beloved basque country region in northern spain. after completing his studies in Veterinary Medicine, he embarked in a 12-year long journey of expertise development, taking him through six countries, four continents and three different industry sectors, gaining along the way three post graduate degrees at universities in the usa and australia. established in brussels since 2007, he has been providing Consulting services for the Pharmaceutical and Biotechnology industries. this involvement in r&d has led to a focus on Innovation as an Entrepreneur, idea generator and a Member of the european industrial Research management association task force for responsible Innovation. he leverages those roles with his broad Education, diverse professional background and eclectic life experience.

biophysical Chemist with ten years’ experience involved in the development of molecular interaction In Vitro Assays and point-of-need IVD Applications using plasmonic gold Nanomaterials

broad knowledge of drug and IVD Discovery Research, Preclinical and Clinical Development

proven-track fast learner and counterintuitive problem solver

Experiences

Current Experience

  • Freelance Scientific/Medical Consultant

    Haasrode
    Since January 2014

    contingent Freelance scientific writer

     

    Scientific writing

     

    roberto collaborates with dr. sven de ferme, Owner of pharma xl, providing services as a contingent scientific writer on a Freelance basis. there, he writes scientific articles for publication in peer-reviewed journals and Documentation required by the regulatory authorities (FDA, EMA) dealing with the Clinical Development of new therapeutic drugs.

     

    approach & main achievements

     

    ·         writing of several reviews and articles dealing with Clinical trials of new therapeutics in the areas of malaria, Cancer and gastro intestinal diseases.

    ·         writing of clinical trail protocols and reports that form part of license Applications dossiers for the use and Commercialization of new drugs.

     

    technical environment & methodologies

     

    ·         use of ms office and SharePoint Document Management system

    ·         scientific/Medical writing methodology

    Contingent Freelance Scientific Writer

     

    Scientific writing

     

    Roberto collaborates with Dr. Sven De Ferme, owner of Pharma XL, providing services as a contingent scientific writer on a freelance basis. There, he writes scientific articles for publication in peer-reviewed journals and documentation required by the regulatory authorities (FDA, EMA) dealing with the clinical development of new therapeutic drugs.

     

    Approach & main achievements

     

    ·         Writing of several reviews and articles dealing with clinical trials of new therapeutics in the areas of Malaria, cancer and Gastro intestinal diseases.

    ·         Writing of clinical trail protocols and reports that form part of license applications dossiers for the use and commercialization of new drugs.

     

    Technical environment & methodologies

     

    ·         Use of MS Office and SharePoint document management system

    ·         Scientific/Medical writing methodology

  • Corporate Research

    Zellik
    Since January 2013

    corporate Research Consultant

     turning gold into life

     

    roberto rejoined pharmadiagnostics n.v. after discussions with new CEO in early 2013. there, he started by identifying the technical challenges that where slowing down the progress of the r&d team and suggesting solutions. he also contributed to the hiring process of the head r&d. later on, he participated in an Innovation project applied to the company product line. later, he continued with corporate Research duties finding new Applications for the core technology and core enabling technologies in the fields of environmental toxiciology, bioporcessing qc, cosmetics and therapeutics.

     

    approach & main achievements

     

    ·         identification of the sources of the technical challenges unknown to the r&d team until then.

    ·         proposal of technical solutions to address the challenges and set up of methodologies for optimization of experimental conditions, currently in use, to avoid the further impediments originating form the same sources.

    ·         identification of novel Applications for plasmonic gold nanorods in different fields with no competitors.

    ·         production of large amounts of ip in unoccupied niches where pharmadiagnostics’s core technologies could fit higher value Applications.

     

    technical environment & methodologies

     

    ·         roberto helped the r&d team using Scientific method and fishbone Problem Solving approaches.

    ·         roberto used value Innovation methodolgy during the Innovation program.

    ·         roberto followed the theory of innovative Problem Solving, tips, to generate the connections between the technology platform and the new technology Applications generating mindmaps that he, later on, checked for its scientific basis and technical feasibility.

    Corporate Research Consultant

     Turning gold into life

     

    Roberto rejoined Pharmadiagnostics N.V. after discussions with new CEO in early 2013. There, he started by identifying the technical challenges that where slowing down the progress of the R&D team and suggesting solutions. He also contributed to the hiring process of the Head R&D. Later on, he participated in an innovation project applied to the company product line. Later, he continued with corporate research duties finding new applications for the core technology and core enabling technologies in the fields of environmental toxiciology, bioporcessing QC, cosmetics and therapeutics.

     

    Approach & main achievements

     

    ·         Identification of the sources of the technical challenges unknown to the R&D team until then.

    ·         Proposal of technical solutions to address the challenges and set up of methodologies for optimization of experimental conditions, currently in use, to avoid the further impediments originating form the same sources.

    ·         Identification of novel applications for plasmonic gold nanorods in different fields with no competitors.

    ·         Production of large amounts of IP in unoccupied niches where Pharmadiagnostics’s core technologies could fit higher value applications.

     

    Technical environment & methodologies

     

    ·         Roberto helped the R&D team using scientific method and fishbone problem solving approaches.

    ·         Roberto used Value Innovation Methodolgy during the innovation program.

    ·         Roberto followed the Theory of Innovative Problem Solving, TIPS, to generate the connections between the technology platform and the new technology applications generating mindmaps that he, later on, checked for its scientific basis and technical feasibility.

Past Experience

  • Scientific Business Expert Mechelen, Belgium

    April 2012 --- October 2012

    scientific business Expert

     

    Discovery unit status analysis

     

    roberto was commissioned by the new cso of galapagos n.v. to establish the general Health of the Discovery unit. more precisely, roberto was asked to carry out an analysis per phase and per project for the entire Discovery portfolio looking for the sources of budget to actual disparities, to identify the challenges and to suggest solutions. once this had been accomplished, roberto collaborated with the cso in preparing an update of the Research alliance model, suggesting changes that will bring the unit back to profitability. finally, roberto was asked by the cso to prepare a scientific study report on the different therapeutic approaches to treat a disease of interest and to suggest experimental alleys for the Discovery of novel therapeutic targets for the same disease. in addition, roberto collaborated with the Bioinformatics and it departments leading the first efforts towards a Document Management system project carrying out a brief user defined specification requests compilation and document inventory.

     

    approach & main achievements

     

    ·         regarding the Discovery unit status analysis, roberto decided to use data from the Finance department to carry out Financial Analysis to identify the challenging areas/projects. in addition, roberto carried out, for his own use, a simple mapping of the Discovery unit management structure and processes to help him in the generation solution suggestions. these analysis templates and metrics are currently being used by the pm office of the Discovery unit and the Finance unit of the entire company.

    ·         based on the insights obtained, roberto produce an updated Research alliance model in collaboration with the cso to bring the unit back to profitability. the suggestions were presented to the executive committee and they were integrated in the current model with minor changes.

    ·         a new disease area of Research was started using, among others, two of the experimental directions suggested by roberto.

     

    technical environment & methodologies

     

    ·         analytical Finance methodology applied to Project Management (budget, actual, revenues per year per project per phase, using ms Excel table pivoting)

    ·         historical financial results analysis for the Discovery unit (revenues vs. actuals per year per project phase, using ms Excel table pivoting)

    ·         document inventory survey

    ·         scientific literature Research

     

  • Interim Scientific/Medical Writer Beerse, Belgium

    October 2011 --- April 2012

    Interim scientific Medical Writer

     

    direct acting antivirals

     

    roberto was commissioned by the Director Medicinal Chemistry to carry out Scientific writing tasks on a backlog of documents to be written that had resulted from the depart of the former scientific writer from the organization after tibotec n.v. was absorbed by johnson & johnson inc. and relocated to beerse. these documents formed part of investigational new drug (ind) application dossiers and the scientific reports and experimental protocols that those ind documents referred to.

     

    approach & main achievements

     

    ·         the Documentation was written according to company qa standards and regulatory authority guidelines meeting the deadlines set by management.

    ·         writing and preparation of manuscripts for submission to peer reviewed journals.

    ·         advising on biophysical chemistry science for basic Research projects to study protein-protein Interactions at lipid bi-layer membranes.

     

     

    technical environment & methodologies

     

    ·         the documents were written according to FDA guidelines for Documentation regarding the Clinical Development of new chemical entities with therapeutic activity

     

     

  • CTRS Coordinator Wavre, Belgium

    April 2011 --- September 2011

    ctrs Coordinator

     

    Clinical Development of Vaccines

     

    roberto was commissioned by the senior manager web disclosure to carry out Clinical Trial results summary, ctrs, disclosure and publication tasks taking care of the review and document drafting processes that form part of the Clinical Development unit at gsk biologicals.

     

    approach & main achievements

     

    ·         ctrs timely writing, reviewing and disclosal according to company qa standards and FDA guidelines for reporting and disclosing of clinical studies in human subjects.

    ·         Clinical Trial protocols reviewing in light of the regulation for the publication of clinical results on www.clinicaltrials.gov.

     

     

    technical environment & methodologies

     

    ·         the documents were written according to FDA guidelines for Documentation regarding the Clinical Development of new chemical entities with therapeutic activity

    ·         validated Document Management system tools, documentum and SharePoint.

     

  • Interim Technical Writer/Medical Facilitator Zwijnaarde, Ghent, Belgium

    August 2010 --- April 2011

    Technical Writer/medical facilitator Interim

     

    development of Biomedical devices (clinical Diagnostics)

     

    roberto was commissioned by the manager Assay development unit to carry out Technical Writer/medical facilitator tasks at innogenetics n.v. as temporal replacement of the Technical Writer due to maternal leave.

     

    approach & main achievements

     

    ·         in collaboration with the it department, contributed significantly to the development and deployment of a company-wide SharePoint environment for electronic archival and retrieval of scientific and regulatory Documentation.

    ·         leading the efforts to draft a user’s request specification Documentation for a customization project to expand datastation db capabilities into r&d Project Management application within the Assay development unit.

    ·         design history file (dhf) archive Compliance gap Analysis in collaboration with the qa department within the unit.

    ·         managing the review process and archiving of dhf Documentation.

    ·         Training of r&d staff on writing scientific reports and protocols according to FDA regulations that applied to the development of Medical Devices.

     

     

    technical environment & methodologies

     

    ·         the documents were written according to FDA guidelines for Documentation regarding the Clinical Development of new chemical entities with therapeutic activity

    ·         validated Document Management system tools and SharePoint.

     

  • Senior Scientist Zellik, Asse, Belgium

    August 2007 --- February 2010

    senior sceintist

     

    HTS Assays with localized surface plasmon resonance of gold Nanoparticles

     

    roberto was commissioned by the cso to carry out the development of a new High Throughput Screening (HTS) assay technology based on the phenomenon of lspr of plasmonic Nanoparticles in solution. he carried out his duties until first generation of the product was launch and european patent application was granted.

     

    approach & main achievements

     

    ·         managing Lab Operations, design and implementation of experimental work, Training technical staff, results Analysis and methods Validation reporting weekly to cso and cto.

    ·         writing and preparing scientific literature for presentation in congresses, publication in scientific journals and patent Applications.

    ·         developing new adme-tox assay parameters with the company’s proprietary technologies.

     

     

    technical environment & methodologies

     

    ·         Laboratory automated equipment programming

    ·         good Laboratory practices envirnonment

  • Business Opportunity Analyst Roppongi, Minato, Tokyo, Japan

    April 2000 --- July 2001

    busines opportunity Analyst

     

    Sales revenue pipeline Analysis from opportunity management system data

    roberto was commissioned by the Finance Manager of ibm Software group Sales and Operations ap to carry Analysis of the sale pipeline for the ap geography in support of the Vice President ibm Software ap and all the Software brand executives of the ap geography.

     

    approach & main achievements

     

    ·         Analysis and review of Sales pipeline, reporting recommendations to geographic area managers, Software brands executives and Vice President.

    ·         participation in the biweekly score card call meetings where the Analysis were discussed with country Sales managers.

    ·         overhaul and restructure of Sales & Operations reports and deployment throughout the geography.

    ·         proposal of new business metrics, reports processes and tactics.

    ·         implementation of new automated Sales pipeline report building process.

    ·         writing and preparing scientific literature for presentation in congresses, publication in scientific journals and patent Applications.

    ·         developing new adme-tox assay parameters with the company’s proprietary technologies.

     

     

    technical environment & methodologies

     

    ·         SQL query language for db Data Mining

    ·         non regulated industry corporate environment

     

Personality

Self Assessment :
Analytical thinkingAdaptabilityApproachabilityAuthenticityCharmCollaborationCommunicativeCreative thinkingCuriosityDependabilityDiligenceEfficiencyFlexibilityIndependenceIndividualityInnovative thinkingInterest in knowledgeKindnessOptimismOrganizationPerspectiveProactivityProblem solvingReaction to stressResiliencyResult OrientedSelf-disciplineService orientedSociabilityStrategic thinkingTrustWillingness to compromise

Knowledge

Self Assessment :
Project Management Biochemistry Cell biology Diabetes Medical devices R&D Scientific writingActions and modes of action of human physiologyAllergy and immunologyAnimal ModelsAntibodiesBiochemistryBiomarkersBiotechnologyClinical study reportsClinical researchClinical trialsConfocal MicroscopyCross-functional team leadershipData AnalysisDiabetesDiagnosticsDrug development processDNAEarly development stageELISAFluorescence MicroscopyGeneral surgeryGeneticsHematologyImmunologyImmunoprecipitationIn VitroINDInfectious diseasesInflammationLaboratoryMedical DevicesMedical writingMicrobiologyMicroscopyMicrosoft OfficeMolecular & Cellular Biologymolecular biologyPCRPharmacokineticsPre-clinical researchPreclinical regulations and practicesPrinciples and ethics of clinical researchProblem-solving methods and troubleshootingProtein ExpressionProtocolR&DScientific methodologyScientific WritingVaccinesPOC Diagnostics

Skills and Expertise

Self Assessment :
Critical Path Project Management MethodologyPublication of articlesProvide medical rationale of diseaseOrganize scientific projects (in biology)Organise meetingsOral presentationOperate research equipmentObserve trends in dataNetworkManuscript reviewManuscript preparation and reviewManuscript preparationmanaging a small teamManage data reporting systemsManage Clinical Trial Management System (CTMS) lifescienceLiaise with research teamInterpret dataPublish scientific projectsRead medical literatureConjugation Chemistry MethodsGold Nanooparticle Synthesis MethodsEnvironmental Toxicology bioassaysQuartz Chrystal MicrobalanceAtomic Absorption SpectroscopyUV-Vis-Fluorescence SpectroscopyTotal Internal Reflection Fluorescence MicroscopyDynamic Light Scattering Caracterization of ColloidsLocalized Surface Plasmon ResonancePlasmonicsWrite papersSolve problemsSearch literature on clinical trialsReview study protocolsReview clinical study reportsResearch at universitiesReport dataInteract with pre-clinical scientistsFinancial reportsExecute scientific projectsCoachCoach staffbudgeting of R&D activitiesBiomarker ResearchArchive documentationAdjust processes Adjust methods Write papers Search literature on clinical trials Use a confocal microscopy Technology research Report data Molecular Diagnostics Interpret data Guide students Develop protocols Create SOPsCollaborate with principal investigatorCollaborate with project teamEvaluate protocolsDevelop clinical strategyDevelop clinical hypothesesDesign scientific projects (in biology)Design clinical presentationData miningData analysisCreates a collaborative team environmentCreate study documentsCreate SOPsCreate clinical documentsControl protocol versionsConfocal microscopyConfirm protocol complianceConduct university research Conduct research at universitiesConduct literature searches Analyze dataNanomedicineNanotechnology

Education

  • Ph.D. in Medicine from University of Sydney in 2006
  • Master Science in Molecular Biotechnology from University of Sydney in 2003
  • Master Science in Agribusiness from Arizona State University in 1997
  • Veterinary Medicine Degree in Veterinary Medicine from Universidad de Zaragoza in 1995

Training and Certification

  • Value Innovation in 2015 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    Spanish
    Native
    English
    Full Proficiency
    French
    Elementary Proficiency
    Japanese
    Elementary Proficiency

Work Preferences

  • Locations I am interested in:
    Anderlecht, Belgium Beerse, Belgium Belgium Braine-l'Alleud, Belgium Braine-le-Comte, Belgium Brussels, Belgium Ghent, Belgium Leuven, Belgium Louvain-la-Neuve, Ottignies-Louvain-la-Neuve, Belgium Wavre, Belgium Zaventem, Belgium
  • Work From Home:
    Yes, 0 to 1 days per week
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl freelancer :    40 Hours per week
    BrightOwl employee :    100% FTE
  • International:
    Yes
  • Availability:
    Mar 2018 : 100%
    Apr 2018 : 100%
    May 2018 : 100%
    Jun 2018 : 100%
    Jul 2018 : 100%
    Aug 2018 : 100%

Area / Region

Ganshoren, Belgium

Others

Driving License
  • Yes

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