Senior Director, Global Clinical Safety

Edwards Lifesciences • Irvine, CA

2d • Onsite

About The Position

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. The Senior Director, Global Clinical Safety - THV will lead global clinical safety strategy and a team of subject matter experts to ensure patient safety, regulatory compliance, and successful clinical program execution. Partner cross-functionally to identify and mitigate risks, guide decision-making at the executive level, and drive high-impact safety initiatives across the business. This role requires onsite presence at our corporate headquarters in Irvine, CA.

Requirements

• Bachelor's Degree in related field
• experience in clinical trial safety required or equivalent work experience based on Edwards criteria
• 10-15 years of related experience in clinical research or industry

Nice To Haves

• Advanced degree required (MD, PharmD, PhD, MS) or equivalent scientific discipline
• Experience working in a regulated industry or clinical trial safety
• Demonstrated track record in people management
• Certification in related field or equivalent work experience based on Edwards criteria
• Proven successful project management leadership skills
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

Responsibilities

• Manage a team of clinical and medical safety SMEs and related activities within an assigned business unit
• 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

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Senior