Edwards Lifesciences Senior Manager, Clinical Development Advanced Technology (Irvine, CA) in Irvine, California
Join us to incubate and explore world-class innovations in Structural Heart Disease to substantially improve patient outcomes.
This is an outstanding opportunity to join an early-stage product development group. Edwards Advanced Technology is passionate about developing solutions for patients suffering from structural heart disease. We are seeking talented, versatile, and agile clinical professionals to join this fast-paced, dynamic team and play a central role in the development of new therapies and devices, from concept though early human-use and pivotal trials. As the Senior Manager, Clinical Development you will be responsible for leading procedure development, clinical education, case support and patient screening for early human use trials.
This role is based in Irvine, California. Comprehensive relocation package is available.
ESSENTIAL JOB FUNCTIONS AND KEY RESPONSIBILITIES:
Manage professionals and oversee the work of procedure development, clinical education, case support and patient screening- for multiple early stage structural heart therapies.
Oversee the development of instructions for use (IFU), physician and clinical specialist training documents, and patient screening procedures for early stage devices.
Interact with external key opinion leaders, imaging professionals and core labs to support procedure development, patient screening, and patient follow up.
Interact with R&D engineering teams to support animal studies, trouble-shoot procedure issues and guide device design changes.
Develop interactive and collaborative relationship with clinical trial investigators.
Excellent problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision making.
Ability to travel up to 30% within U.S.
Bachelor's or advanced degree required.
Minimum of 12 years consistent and progressive professional experience in medical device.
Must have Class III implantable device experience.
Understanding of clinical procedures, processes, and systems.
Demonstrated ability to manage a professional team and provide coaching, feedback, and talent development.
- Previous experience in early stage therapy and procedure development and patient screening preferred.
ADDITIONAL SKILLS AND GENERAL EXPECTATIONS:
Ability and desire to work and excel within a fast paced and dynamic work environment.
Demonstrated ability to influence others and develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
Ability manage complex projects and drive achievement of objectives.
Knowledge of the catheter lab environment and direct experience in case support desirable.
Manage a team of employees and oversee clinical development activities.
Excellent written and verbal communication skills. Experienced in analyzing and presenting data.
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.