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Edwards Lifesciences LLC
California, United States (on-site)
16 days ago
Edwards Lifesciences LLC
California, United States
(on-site)
16 days ago
Job Type
Full Time
Job Duration
Indefinite
Salary
$169,000.00 - $239,000.00
Min Experience
Over 10 Years
Min Education
BA/BS/Undergraduate
Required Travel
0-10%
Salary - Type
Yearly Salary
Job Function
Other

Description

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. 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:

As a Senior Director, Global Clinical Safety – Transcatheter Heart Valve will manage a team of clinical and medical safety SMEs (Subject Matter Experts) and related activities within an assigned business unit. This role will provide leadership and clinical expertise in support of new product development and marketed products for the team. Your role is critical to the success of the THV Clinical Affairs safety organization.

  • Direct clinical and medical safety activities with overall responsibility of developing systems, planning, staffing, budgeting, managing expense priorities, recommending, and implementing changes to methods through several managers. Develop a robust talent development and succession planning in alignment with functional growth strategies across the global clinical safety organization.

  • Mitigate/eliminate risk, direct and communicate highly complex clinical safety strategies which includes negotiations with internal and external parties.

  • Plan and direct strategic activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives. Lead in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams.

  • Analyze, formulate, and present recommendations to advise and guide executive level leadership; develop and deliver executive level communication.

  • Lead CEC or DMC meetings as needed



Requirements

What you'll need (Required):

  • Bachelor's Degree in in related field related experience in clinical trial safety required and skill levels exceeding the requirements of the Senior Manager.

  • 15+ years of relevant experience is required

What else we look for (Preferred):

  • Nurse Practitioner (NP) with a Master of Science in Nursing (MSN) or advanced practice registered nurse (APRN) or equivalent

  • MD, DO, MBBS or equivalent degree from an accredited medical school.

  • Expert in CEC or DMC processes

  • Expert in FDA processes

  • Experience working in a regulated industry.

  • Relevant clinical trial experience in cardiology, especially related to heart valve disease, coronary artery disease, peripheral vascular disease, and congestive heart failure areas.

  • Experience with Class III medical devices

  • Continuing education in clinical research monitoring or experience in clinical research

  • Experience in managing clinical trial steering committees.

  • Experience in clinical, regulatory, and marketing aspects of medical device technology

  • Demonstrated track record in people management.

  • Proven successful project management leadership skills.

  • Excellent problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision making.

  • Expert understanding of clinical safety procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems.

  • Expert knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies.

  • Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations.

  • Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of clinical safety to the business.

Job ID: 72320815
Life Science
Irvine , California , United States

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 ove...

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