Senior Director, Clinical Affairs

Edwards Lifesciences • Irvine, CA

3d • $209,000 - $296,000

About The Position

The Senior Director, Clinical Affairs provides leadership and clinical expertise in support of new product development and marketed products. The role leads a global clinical studies portfolio, including studies launched in 2026 and planned for 2027, and directs strategic clinical activities across the organization. This includes developing systems, planning and staffing, managing budgets and expenses, and recommending and implementing improvements through managers and experienced professionals. The Senior Director also builds talent development and succession planning in alignment with clinical organization growth strategies.

The role oversees trial management, CRO staff, and field clinical specialists working on Edwards’ research programs. It partners with investigators, physicians, study sites, internal teams, and cross-functional stakeholders to deliver trials on time and in compliance with global processes, regulations, and good clinical practices. The position also provides strategic direction, manages complex projects and risks, develops and maintains key opinion leader relationships, and contributes to scientific communications and executive-level guidance.

Requirements

• Bachelor's degree in a scientific or related discipline, with related experience including clinical strategy.
• Demonstrated track record in people management and ability to lead and manage a diverse team across multiple geographies.
• Experience with Class II and III medical devices is preferred; documented current continuing education in clinical research monitoring or experience in Clinical Research.
• Proven experience working effectively with investigators, physicians, and site study teams.

Nice To Haves

• Clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease, and congestive heart failure.
• Experience managing pivotal and post-approval clinical trials in the United States and Europe.
• Experience in clinical, regulatory, and marketing aspects of medical device technology.
• Expert understanding of clinical regulations, guidelines, and procedures, including ICH/GCP E6, ISO 14155, CFR 820, Canadian Medical Device Regulation (CMDR), and EU MDD/MDR.
• Excellent financial and business acumen.
• Expert understanding and application of industry best practices.
• Ability to develop and integrate operational and project metrics demonstrating Clinical Affairs’ value to the business.
• Understanding of biostatistical and actuarial methods.

Responsibilities

• Direct clinical activities and develop systems, plans, staffing, budgets, expense priorities, and methods for the clinical organization.
• Develop talent, coaching, and succession plans aligned with clinical organization growth strategies.
• Oversee the management and training of trial management staff, CRO staff, and field clinical specialists working on research programs.
• Analyze information and formulate and present recommendations to advise executive-level leadership; develop and deliver executive communications.
• Mitigate risk and direct complex projects, initiatives, and strategies, including negotiations with internal and external parties.
• Plan and direct strategic activities, prioritize projects, and ensure business objectives are met.
• Identify risks, develop mitigation strategies and alternative solutions, resolve issues, and establish best practices with cross-functional and matrix teams.
• Ensure clinical trials are executed on time and in accordance with global clinical processes, regulations, and good clinical practices.
• Partner with internal team members across functions to drive clinical trial success.
• Provide strategic leadership and direction, including developing and maintaining significant key opinion leader relationships.
• Contribute to scientific communications, including clinical data reports and presentations for regulatory submissions, conferences, and study meetings such as Executive Committees, DSMBs, CECs, and Steering Committees; ensure accuracy and relevance.
• Lead large cross-functional teams in implementing global enterprise systems and related solutions.
• Manage multiple projects and meet deadlines.
• Direct teams and provide coaching and feedback; oversee employee actions, including hiring and firing, and partner with HR on employee relations.
• Develop and integrate metrics into projects and operations to demonstrate the value of Clinical Affairs to the business.
• Serve as a core partner to senior leaders in business units, functional groups, and regions.
• Comply with applicable U.S. and global regulations and standard operating procedures.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address employees’ and their families’ diverse individual needs

What This Job Offers

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