Director, Clinical Case Review & Simulation

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

Benefits offered by this job

Competitive salary

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences in Irvine, CA seeks a Director to lead a team, educate on THV technologies, and collaborate with surgeons and clinicians to advance patient care.

You will drive screening and imaging review programs, oversee digital simulation, and synthesize data from cases and procedures to inform clinical and operational decisions.

Qualifications

• Bachelor's Degree in scientific or related discipline is required.
• Master's Degree or equivalent in scientific discipline is preferred.
• Proven project management skills and ability to train and educate clinical teams.

Responsibilities

• Manage a team and serve as a scientific resource to educate and support on advances and uses of Edwards Lifesciences devices.
• Develop and lead a program for clinical patient screening and imaging review of complex cases 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 extracting, validating, and synthesizing information from case reviews and procedures.
• Measure and evolve the clinical case review program with governance practices.
• Identify knowledge gaps and coordinate cross-functional remediation.
• Oversee wet-lab based simulation training events in Edwards Campus Cath Labs.

Skills

Project management

Presentation skills

Interpersonal skills

Regulatory knowledge

Microsoft Office

Data analysis

Communication skills

Stakeholder influence

Education

Bachelor's Degree in scientific discipline

Master's Degree or equivalent

Tools

Database management

Microsoft Office Suite

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). 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.