Senior Manager, Clinical Development Advanced Technology (Irvine, CA)
Company: Edwards Lifesciences Gruppe
Posted on: February 23, 2021
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account. Thank you for your patience. Senior Manager, Clinical
Development Advanced Technology (Irvine, CA) USA - California -
Irvine Join us to incubate and explore world-class innovations in
Structural Heart Disease to substantially improve patient
-- 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
- 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
- Develop interactive and collaborative relationship with
clinical trial investigators.
- Excellent problem-solving, organizational, analytical, and
critical thinking skills including high discretion/judgment in
- Ability to travel up to 30% within U.S. MINIMUM REQUIREMENTS:
- Bachelor's or advanced degree in an engineering, biologic life
- Minimum of 12 years consistent and progressive professional
experience in medical device research and development.
- Must have Class III implantable device experience.
- Understanding of clinical procedures, processes, and
- Demonstrated ability to manage a professional team and provide
coaching, feedback, and talent development. PREFERRED SKILLS:
- 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
- --Knowledge of the catheter lab environment and direct
experience in case support desirable.
- Manage a team of employees and oversee clinical development
- Excellent written and verbal communication skills. Experienced
in analyzing and presenting data. E dwards is an Equal
Opportunity/Affirmative Action employer including protected
Veterans and individuals with disabilities. Posted 2 Days Ago Full
time Req-5210 About Us 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.
Keywords: Edwards Lifesciences Gruppe, Irvine , Senior Manager, Clinical Development Advanced Technology (Irvine, CA), Executive , Irvine, California
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