1) Graduated in Medicine and Surgery (UAB -1982). Master in Pharmaceutical Medicine (Hospital de Sant Pau - Barcelona ). Languages: Spanish, Catalan, English and French. 2) Professional background: a) Practitioner (1983-1988): Primary Care, Surgery and Emergency Wards. b) Pharma Industry: - Lacer (Medical Adviser - 1988) - Ipsen as a Medical Adviser from 1989 to 2002. - Ipsen as Medical Director from 2003 to 2013. - Executive Committee member of the Ipsen Spanish affilliate. - Ipsen-Pharma Foundation President from 2011 to February 2014. - MedSIR: Medical Affairs Manager from November 2014. 3) Internet: please, type "José A. Delgado, Ipsen". You will see my published papers and public prez. http://www.ncbi.nlm.nih.gov/pubmed/22464195 http://www.pmfarma.es/incs/user/login.php?txt=1 http://www.pmfarma.es/incs/user/login.php?txt=1 4) Professional and scientific associations: - AEC Working group on Medical Department Organization. Paris, France, 2006 - AMlFE (Asociación de Medicina de la Industria Farmacéutica). - Colegio de Médicos de Barcelona. - BEST (Grupo de Directores Médicos) de FARMAINDUSTRIA - GIC (Grupo de Investigación Clínica) de FARMAINDUSTRIA - IPSEN clinical trial Committee, 2008. - IPSEN Global Medical Cover Group and 1st SOP Reviewer. - IPSEN PEC member (IPSEN Clinical studies Protocol Evaluation Committee) since 2007 to 2013. - IPSEN Synopsis Working Group Leader (SYNOWOG) - 2010 to 2012 - IPSEN Working Group member on Local Clinical Studies Approval Process - 2012 & 2013 - Member of ANEEE (Entrepreneurs Spanish Association) since July 2014
Worldwide Medical Affairs Manager
November 2014 --- February 2015
MedSIR ARO is an Academic Research Organization focused on Oncology at International level. As a Medical Affairs Manager (MAM) I was in charge of medical support to MedSIR’s clinical operations worldwide. Pharma sector.
In practical terms, I was in charge of setting up a phase II Clinical Trial in Metastasic Breast Cancer across 9 countries. I've been visiting around 15 sites at the UK, Germany and the Czech Republic where I've had the opportunity to present the company and the trial to the corresponding Oncology Services. I've received some congrats of the KOL and I have also a Recommendation letter of my former company. This job has been done just by myself.
November 2011 --- February 2014
Ipsen representative in Farmaindustria
January 2003 --- December 2013
I was the Ipsen representative in two working groups: "Grupo de Investigación Clínica" (Clinical Research Group) and the BEST Project (Best is a strategic project promoted by the pharmaceutical industry which integrates all of the public and private stakeholders to create a platform of excellence for clinical research in medicinal products in Spain).
January 2003 --- December 2013
Managing a team of 12 people Clinical studies / Sales representatives training / Promotional material / Medical cover 24h day / KOL contacts / Budget holder / Cross-functional relationships with other Company Departments (Marketing, Sales, RIMA, Regulatory Affairs, HH.RR.; etc.) / Key medical position between the Spanish affiliate and HQ in order to get internal clinical studies approvals (more than 30 in December 2013 with 100% of success, so no one refusal from HQ during 10 years negotiating clinical sudies) / Specialist in PMS studies / Strategic thinking / Expertise areas: Urology, Endocrinology, Paediatrician Endocrinology, Neurology, Rehabilitation and Oncology (prostate cancer and neuroendocrine tumours).
Senior Medical Advisor
February 1989 --- December 2002
I was in charge of all the portfolio Ipsen products re training, medical requests, KOL contacts, promotional material, bibliography database, etc.
March 1988 --- October 1988
It was my first experience in the Pharmaceutical Industry.
AdaptabilityOrganizationProactivityProblem solvingResiliencySelf-disciplineSociabilityStrategic thinkingTrustOptimismInnovative thinkingFlexibilityAnalytical thinkingApproachabilityAssertivenessAuthenticityCompetitivenessCoordinationCritical thinkingEfficiencyWillingness to compromise
Clinical trial audits and inspectionsClinical trial designClinical trial managementClinical trialsContract negotiationCross-functional team leadershipDrug InteractionDrug metabolismDrug Safety and PharmacovigilanceDrug Supply Management activitiesEMAEndocrinology and metabolismEndocrinologyEnglishGCPGeneral practiceGeneral surgeryGood Clinical Practice (GCP)GynecologyInformed Consent ProcessInterpret clinical trial resultsInterpret clinical trial resultsInterpret systematic reviewsKOL managementLegal Considerations: Contracts and IndemnityMarket accessMarketing approvalMarketing Authorisation Application (MAA)Medical affairsMedical budget managementMedical oncology Microsoft ExcelMicrosoft OfficeNegotiationNeurologyoncologyPatient Screening and RecruitmentPharmaceutical IndustryPharmacokineticsPharmacovigilancePhase IPhase IIIPhase IIPhase IVPhases of clinical development (phase I to IV)PowerPointPodiatric medicinePrinciples and ethics of clinical researchProtocolSafety concerns (such as therapeutic ratio with respect to possible adverse effects)Safety trialsSearch literature on clinical trialsSerious Adverse Event (SAE)Statistical considerations in design and analysisSupervising CRAsTeam LeadershipUnderstand how results translate to practiceUrologyInformed Consent DocumentsWriting Study Procedures and SOPs Negotiation Phase I Scientific writingA rising single dose tolerance studyCancerClinical monitoringClinical operationsClinical Study DesignClinical research
Skills and Expertise
Review vendor metricsReview vendor reports Create SOPsSelect contractors Design case record formsSelect investigators Develop clinical trial protocolsSerious Adverse Event (SAE) Reconciliation Develop protocolsSet up a clinical study Interact with physiciansSolve problems Interpret dataWork under specific instructions Monitor a clinical studywrite and maintain clinical evaluation reports Search literature on clinical trialsWrite protocols Write papersWritten presentationAdverse event reportingAdvise on medical perspectivesApprove consent documentsApprove drug supply Approve Label Master SheetApprove monitoring reportsApprove patient informationAssess adverse reactionsAssure medical qualityAttend investigator meetingAttend seminarsAttend steering committeebudgeting of R&D activitiesCalculate trial timelinesCoach clinical staffCoach staffCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamCollect financial data from hospitalsCollect patient forms and questionnairesCommunicate with investigatorCommunicate with sponsorComplete case report form (CRF)Complete study proceduresConduct literature searchesConduct post-marketing surveillance studyConduct the trialCoordinate ethics committeeCoordinate logisticsCreate SOPsCreate standard operating procedure (SOP)Create economic parametersDesign clinical trialDesign exclusion criteriaDesign inclusion criteriaDesign information leafletDesign post-marketing surveillance studyDesign protocolDesign studyDocument adverse eventsDocument employees training requirementsEnsure good clinical practice (GCP)Ethics committee applicationEthics committee submissionsEvaluate licensing opportunitiesEvaluate protocolsFinancial administrationFinancial reportsFollow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesForecasting of drug productHandle callsIndentify clinicians to conduct clinical trialsIdentify investigatorsIndentify sitesInformed consent processInteract with CROsInteract with ethics committeeInteract with pharmacistsInterpret dataLiaise with doctorsLiaise with research teamManage Clinical Trial Management System (CTMS) Manage study budgetManage trial master file (TMF)Manage vendor budgetsmanaging a small teamNegotiate budget NetworkOral presentationOrganise meetingsOrganise steering committeeParticipate in medical reviewPatient recruitmentPersuade clinicians to conduct clinical trialsPlanning clinical studiesPrepare external auditsPresent at steering committeePresent clinical resultsPresent data at congressPromotional materialsProtocol managementProvide benefit risk assessmentProvide medical content for clinical development planProvide medical insightsProvide trainingPublication of articlesRead medical literatureReport serious adverse events (SAE)Review clinical study reportsReview exclusion criteriaReview inclusion criteriaReview medical reportsReview study protocolsReview vendor metricsReview vendor reportsSelect contractors Select investigatorsSerious Adverse Event (SAE) ReconciliationSet up a clinical studySolve problemsWork under specific instructionswrite and maintain clinical evaluation reportsWrite protocolsWritten presentation
No one in English from Castleisland, Killarney, Ireland in 1996
Certificado del centro in Idiomas - Inglés from IEN (Instituto de Estudios Norteamericanos) in 1995
TOEFL in Inglés from IEN (Instituto de Estudios Norteamericanos) in 1995
Master in Pharmaceutical Industry. in Pharmaceutical Industry from Hospital de Sant Pau in 1989
Sergeant in Infantry Medical Sergeant from Spanish Army in 1983
Licentiate degree in Medicine from Universidad Autónoma de Barcelona - UAB in 1982
Expert has 3 publications (Will be avalible with full profile)