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Reporting to the VP Clinical Affairs TMTT, this role may also be part of the European TMTT leadership Team.%3C/font%3E%3C/li%3E%3C/ul%3E%3C/div%3E%3Cdiv%3E%3Cb%3E%3Cfont face=%22Verdana%22%3EMajor Job Functions%5C:%26nbsp;%3C/font%3E%3C/b%3E%3C/div%3E%3Cdiv%3E%3Cul%3E%3Cli%3E%3Cfont face=%22Verdana%22%3EPartner with Global Platform Clinical Affairs leaders to execute clinical studies that are conducted in European sites.%3C/font%3E%3C/li%3E%3Cli%3E%3Cfont face=%22Verdana%22%3EPartner with key regional and global internal stakeholders (Business leaders, Market Access, Regulatory, Quality, Legal) to coordinate the regional TMTT Clinical strategy and programs%26nbsp;%26nbsp;%3C/font%3E%3C/li%3E%3Cli%3E%3Cfont face=%22Verdana%22%3EContinuously optimize and resource the team to deliver on the TMTT EU clinical trials.%3C/font%3E%3C/li%3E%3Cli%3E%3Cfont face=%22Verdana%22%3ELead the EU TMTT Clinical Affairs trial execution team. Manage relationships with physician investigators, research hospitals and institutions, and Clinical Research Organizations.%26nbsp;%26nbsp;%3C/font%3E%3C/li%3E%3Cli%3E%3Cfont face=%22Verdana%22%3EExecute and help design clinical trials and studies that comply with global clinical, regulatory, and legal requirements, while generating evidence per company strategy.%3C/font%3E%3C/li%3E%3Cli%3E%3Cfont face=%22Verdana%22%3EDeliver Clinical Trial studies while ensuring compliance with regulations and company SOPs.%3C/font%3E%3C/li%3E%3Cli%3E%3Cfont face=%22Verdana%22%3EDrive process improvement and initiate corrective actions to resolve any compliance issues.%26nbsp;%3C/font%3E%3C/li%3E%3Cli%3E%3Cfont face=%22Verdana%22%3EDevelop team members and assure all have training plans and development planes. 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Reviews critical regulatory submissions.%3C/font%3E%3C/li%3E%3C/ul%3E%3C/div%3E%3Cdiv%3E#LI-MC1%3C/div%3E%3C/div%3E%3C/font%3E!|!!!%3Cfont size=%223%22%3E%3Cdiv style=%22%22%3E%3Cdiv%3E%3Cb%3ERequired Education/Skills/Experience%5C:%3C/b%3E%3C/div%3E%3Cdiv%3E%3Cul%3E%3Cli%3E%3Cfont face=%22Verdana%22%3EAdvanced degree is preferred (Master's degree, Ph.D., M.D.), or relevant level of experience running structural heart trials. 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Driven by a passion to help patients, the company collaborates with the world%27s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.%3C/span%3E%3C/p%3E %3Cp style=%22margin%5C:0in;font-family%5C:Arial;font-size%5C:12.0pt;color%5C:black%22%3E%3Cspan style=%22background%5C:white%22%3E%26nbsp;%3C/span%3E%3C/p%3E %3Cp style=%22margin%5C:0in;font-family%5C:verdana;font-size%5C:12.0pt;color%5C:black%22%3E%3Cspan style=%22background%5C:white%22%3EFor us, helping patients is not a slogan - it%27s our life%27s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.%3C/span%3E%3C/p%3E %3C/div%3E %3C/div%3E %3C/div%3E%3C/font%3E!|!!*!%3Cfont size=%223%22 face=%22Arial%22%3E%3Cdiv style=%22direction%5C:ltr;border-width%5C:100%%22%3E %3Cdiv style=%22direction%5C:ltr;margin-top%5C:0in;margin-left%5C:0in;width%5C:7.5in%22%3E %3Cdiv style=%22direction%5C:ltr;margin-top%5C:0in;margin-left%5C:0in;width%5C:7.5in%22%3E %3Cp style=%22margin%5C:0in;font-family%5C:verdana;font-size%5C:12.0pt;color%5C:black%22 lang=%22en-US%22%3E%3Cspan style=%22font-weight%5C:bold;background%5C:white%22%3EAbout Edwards%3C/span%3E%3C/p%3E %3Cp style=%22margin%5C:0in;font-family%5C:verdana;font-size%5C:12.0pt;color%5C:black%22%3E%3Cspan style=%22background%5C:white%22%3EEdwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world%27s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.%3C/span%3E%3C/p%3E %3Cp style=%22margin%5C:0in;font-family%5C:Arial;font-size%5C:12.0pt;color%5C:black%22%3E%3Cspan style=%22background%5C:white%22%3E%26nbsp;%3C/span%3E%3C/p%3E %3Cp style=%22margin%5C:0in;font-family%5C:verdana;font-size%5C:12.0pt;color%5C:black%22%3E%3Cspan style=%22background%5C:white%22%3EFor us, helping patients is not a slogan - it%27s our life%27s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.%3C/span%3E%3C/p%3E %3C/div%3E %3C/div%3E %3C/div%3E%3C/font%3E!|!Clinical Affairs!|!Clinical Affairs!|!Europe, Middle East, Africa, Canada (EMEAC)-Switzerland!|!Europe, Middle East, Africa, Canada (EMEAC)-Switzerland!|!!|!!|!false!|!260060!|!260060!|!true!|!260060!|!false!|!Submission for the position%5C: Dir, Clinical Affairs TMTT, Europe - (Job Number%5C: 015307)!|!false!|!260060!|!false!|!true!|!https%5C://edwards.taleo.net/careersection/jobdetail.ftl?job=015307%26lang=en!|!Dir, Clinical Affairs TMTT, Europe!|!true!%24!ftlerrors!|!!|!descRequisition.size!|!1!|!descRequisition.nbElements!|!1!|!descRequisition.isEmpty!|!false!|!descRequisition.hasElements!|!true!|!pSessionTimeout!|!0!|!pSessionWarning!|!0!|!pBeaconBeat!|!0!|!focusOnField!|!!|!csrftoken!|!Vef9kiDfIKuhmj2+BfAG4/5ad7CqlcGSdyu5BaMyHvw=!|!emptyListToken!|!!|!isListEmpty!|!false!|!listCount!|!!|!displayCalloutInLegend!|!false!|!addThisRequired!|!true!|!jobboardListPageTitle!|!!|!commonDescriptionForAddThis!|!!|!alreadyAppliedColumnDisplayed!|!false!|!displayDraft!|!!|!displaymessage!|!false!|!initialHistoryPage!|!1!|!restoreInitialHistoryOnRefresh!|!false!|!applicationCandidateNo!|!!|!calloutPageDisplayed!|!false!|!descriptionLogginMandatory!|!false!|!displayAsMainHeader!|!false!|!displayListingsPerPage!|!false!|!displayUrgentNeed!|!!|!isApplicantUser!|!true!|!jobsPerPageCaption!|!Job {0} out of {1}!|!listEmptyIsApplicantUser!|!true!|!listLabels!|!!|!listLocales!|!!|!requisitionno!|!260060!|!interfaceIdForTimeZone!|!requisitionDescriptionInterface!|!isJobCartActionDisplayed!|!true!|!openDescFrom!|!default!|!serializedCriteria!|!!|!sortby!|!11!%24!requisitionDescriptionInterface!|!!|!!|!!|!!|!!|!Apply for this position online!|!Apply by Email!|!Apply to this position by email!|!Add this position to the job cart!|!!|!Job Description!|!About Edwards!|!Tell us about a friend who might be interested in this job. All privacy rights will be protected.!|!false!|!Tell us about a person who might be interested in working for our organization. All privacy rights will be protected.!|!true!|! !|!Apply for this position online!|!Apply to this position by email!|!Add this position to the job cart!|!!|!!|!!|!