Director, Clinical Case Review & Simulation

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

Job summary

Edwards Lifesciences, Irvine, CA, is seeking a Director to lead our Transcatheter Heart Valve (THV) clinical program. You will educate, train, and support clinicians on device advances, drive imaging review programs, and guide data analyses to improve patient outcomes.

You will manage cross-functional teams, oversee simulations, and align initiatives with regulatory and safety standards while advancing the evidence base for TAVR applications.

Qualifications

• Bachelor's degree in scientific or related discipline, with 12 years related experience.
• Master's degree or equivalent in scientific or related discipline with 10 years related experience.
• Experience in interventional cardiology, cardiac cath lab, or structural heart preferred.

Responsibilities

• Lead a team and serve as a scientific resource to educate, train, advise and support on advances and uses of Edwards Lifesciences technologies and devices.
• Develop and evolve programs for clinical patient screening and imaging review of complex cases to ensure quality outcomes and satisfaction across multiple teams.
• Oversee development and implementation of digital simulation technologies aligned with BU goals and physician training needs.
• Lead data and insights initiatives by partnering with SMEs to extract, validate, and synthesize information from case reviews and procedural data.
• Measure effectiveness of the clinical case review program and establish governance practices.
• Identify knowledge gaps in clinical case reviews and coordinate cross-functional remediation.
• Oversee wet-lab based simulation training events on transcatheter procedures at Edwards Campus Cath Labs.

Skills

Project management

Interventional cardiology guidance

Clinical development

Data analysis

Regulatory compliance knowledge

Education

Bachelor's degree in scientific discipline

Master's degree in scientific discipline

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 devices
• Lead 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 remediation
• Oversee delivery of wet-lab based simulation training events on transcatheter procedures, in the Edwards Campus Cath Labs

What you’ll need (required):

• Bachelor's Degree in scientific or related discipline with 12 years related experience
• Master's Degree or equivalent in scientific or related discipline with 10 years related experience

What else we look for (preferred):

• Proven successful project management skills
• Formal 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 analysis
• Must excel at interacting with sales colleagues and physicians
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Understanding of cardiac & vascular anatomy and THV/TAVR procedure
• Extensive knowledge and understanding of policies, procedures and guidelines relevant to interacting with HCP's
• Excellent facilitation and presentation skills
• Must be able to influence and guide stakeholders
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Expertise in Microsoft Office Suite
• Knowledge and understanding of Regulatory, Legal, Compliance aspects of MedTech industry
• Knowledge of regulatory requirements and AdvaMed
• Ability 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/control

Aligning 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).