Director, Clinical Case Review & Simulation

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 174,000 - 246,000; Full time

Job summary

Edwards Lifesciences Irvine, CA, seeks a Director to lead a multidisciplinary team focused on transcatheter heart valve (THV) advances. You will educate clinicians, train staff, and support integration of new technologies while aligning with business goals and regulatory standards.

You will develop programs for patient screening, imaging review, and data insights, ensuring excellent outcomes and cross-team collaboration across sales, physicians, and clinical affairs.

Qualifications

• Bachelor’s degree in a scientific or related discipline with 12 years related experience.
• Master’s degree or equivalent in scientific or related discipline with 10 years related experience.

Responsibilities

• Lead and manage a team; educate, train, advise and support on advances in THV/TAVR technologies.
• Oversee clinical patient screening and imaging review for complex cases to ensure quality outcomes and stakeholder satisfaction.
• Drive data and insights initiatives by extracting and synthesizing information from case reviews, imaging, and procedural data.
• Oversee wet-lab based simulation training events on transcatheter procedures.
• Coordinate cross-functional activities across sales, physicians, clinical imaging, and clinical affairs to achieve objectives.

Skills

Leadership

Project management

Data analysis

Presentation skills

Stakeholder management

Education

Bachelor's degree (scientific or related)

Master's degree or equivalent

Tools

Microsoft Office

Job description

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.How you will make an impact:The Director will manage a team, and serve as a scientific resource to educate, train, advise and support on upcoming advances and uses of technologies and devices provided by Edwards Lifesciences including engaging with the wider surgical and medical community.Develop, lead and evolve program for clinical patient screening and imaging review of complex cases ensuring quality patient outcomes and overall internal and external customer satisfaction across multiple teams (i.e. sales, physicians, clinical imaging, FCS, Clinical Affairs, Safety).Oversee development and implementation of digital simulation technologies, consistently with BU strategic goals, evolving physician training needs, introduction of new technologies or new applications for commercially approved devicesLead data and insights initiatives by partnering with technical subject matter experts to extract, validate, and synthesize information from case reviews, imaging assessments, and procedural data. Identify gaps or trends in available information, and pursue analyses that generate actionable clinical and operational insights Measure effectiveness and evolve clinical case review program utilizing process improvement and establishing and communicating governance practices. Identify knowledge gaps related to clinical case reviews and work closely with cross-functional team to facilitate case review remediationOversee delivery of wet-lab based simulation training events on transcatheter procedures, in the Edwards Campus Cath LabsWhat you’ll need (required):Bachelor's Degree in scientific or related discipline with 12 years related experienceMaster's Degree or equivalent in scientific or related discipline with 10 years related experienceWhat else we look for (preferred):Proven successful project management skillsFormal education and clinical experience in one or more the following specialties/areas preferred: Interventional Cardiology/Cardiac Cath Lab, CT Surgery, Structural Heart Nursing (RN/BSN/MSN), Physician Assistant (PA-C), RCIS/CVT/RTR, Clinical Development in MedTech Industry (preferably in cardiovascular space)Three years clinical TAVR experience/knowledge strongly preferred.Experience in database management and basic analysisMust excel at interacting with sales colleagues and physiciansExcellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making Understanding of cardiac & vascular anatomy and THV/TAVR procedureExtensive knowledge and understanding of policies, procedures and guidelines relevant to interacting with HCP'sExcellent facilitation and presentation skillsMust be able to influence and guide stakeholdersExcellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectivesExpertise in Microsoft Office Suite Knowledge and understanding of Regulatory, Legal, Compliance aspects of MedTech industryKnowledge of regulatory requirements and AdvaMedAbility to work and excel within a fast paced, dynamic, and constantly changing work environment Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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/controlAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California (CA), the base pay range for this position is $174,000 to $246,000(highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.