Edwards Lifesciences Manager, Clinical Education (EVOQUE) - TMTT in Irvine, California
Edwards has a unique opportunity to play a critical leadership role in the growth of new cutting edge heart valve therapies for Transcatheter Mitral and Tricuspid Therapies (TMTT). As Manager, Clinical Education within TMTT supporting the EVOQUE device, you will manage a team of Clinical Education Specialists which may include participating in case support and training. Additionally you will work closely with global KOLs and the Edwards' Clinical Research Teams across several exciting therapeutic devices. You will have direct impact to procedural development of our technologies as we bring early-stage technologies through Clinical Trials and towards commercial markets.
Manage and oversee the work of small team of Clinical Education Specialists who provide Training and Case Support for TMTT Clinical Trials, including the management of a robust talent development plan in alignment with functional growth strategies of the department
Develop and lead in the implementation of clinical trial device case support and procedural training plans which align with TMTT Clinical Trials, including Physician Training
Case support planning, content collaboration, and clinical site start-up sctivities. This may include being trained to proctor cases, prep devices, and perform training activities
• Manage activities with the accountability for successful completion of clinical trial deliverables related to start-up enrollment activities (e.g., physician training, device management, case performance and study enrollment).
• Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams including external sites (e.g., physician's team)
• Collaborate with team members to lead global projects in support of clinical trial and/or device knowledge transfer (e.g., cross-training with regional teams)
Basic Qualifications and Minimum Requirements:
Bachelor's degree in relevant field and recent experience in the management of clinical education teams for the medical device industry
Demonstrated track record of direct people-leadership
Master's Degree or equivalent in in related field
Experience in interventional cardiology or cardiothoracic surgery
Structural heart device experience
Additional Talents and General Expectations:
• Excellent facilitation and presentation skills
• Experience working in a regulated industry preferred
• Proven successful project management leadership skills
• Proven expertise in Microsoft Office Suite and related tools and systems
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Expert understanding of clinical trial procedures and clinical devices while addressing issues with impact beyond own team based on knowledge of related disciplines
• Expert understanding of related aspects of clinical protocol and device procedural processes and/or systems
• Knowledge of financial mechanism that relates to device reimbursement and payment at the site level
• Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of their role to the business
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Frequently interacts with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team
• Participate and present at meetings with internal and external representatives
• Resolve operational and scheduling issues
• Dedicated to quality client service and pro-active and responsive to client needs.
• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
• Develop relationships and leverage them to influence change
• Support and solicit input from team members at all levels within the organization
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards 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's 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 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's 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.