Senior Director, Clinical Affairs

Edwards Lifesciences; Irvine (CA); On-site; USD 209,000 - 296,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA seeks a senior leader for Clinical Affairs to drive clinical strategy and oversee global studies. You will lead trials, manage cross-functional teams, and partner with investigators and regulatory bodies to deliver high-quality evidence for new and marketed devices.

The role emphasizes strategic leadership, risk mitigation, and development of KOL relationships across regions, with a strong focus on patient outcomes and regulatory submissions.

Qualifications

• Bachelor's Degree in scientific or related discipline with related experience including clinical strategy.
• Proven experience in effectively working with Investigators, physicians and site study teams.
• Demonstrated track record in people management with ability to lead and manage a diverse team across geographies.

Responsibilities

• Direct clinical activities with responsibility for developing systems, planning, staffing and budgeting; manage expenses and mentor staff.
• Oversee management and training of trial management, CRO staff and field clinical specialists.
• Analyze, formulate and present recommendations to executive leadership; deliver executive-level communications.
• Mitigate risks and direct complex projects and strategies involving internal and external stakeholders.
• Plan and direct strategic activities, prioritize projects and ensure meeting business objectives with cross-functional teams.
• Ensure on-time execution of clinical trials in accordance with global processes and regulations.

Skills

People management

Clinical research experience

Investigator collaboration

Education

Bachelor's degree in science

Job description

USA - California – Irvine

Full time

Req-49649

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.

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. 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, Clinical Affairs will provide leadership and clinical expertise in support of new product development and/or marketed products. We launched several clinical studies in 2026 and plan to start more in 2027. We are looking for an experienced trials leader with great people leadership skills to join our team and lead our global studies portfolio.

How you will make an impact

• Direct clinical activities with overall responsibility of developing systems, planning, staffing, budgeting, managing expense priorities, recommending and implementing changes to methods through manager(s) and/or experienced professionals. Develop a robust talent development and succession planning in alignment with functional growth strategies across the clinical organization

• Oversee the proper management and training of all trial management, CRO staff and field clinical specialists working on Edwards’ research programs

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

• Mitigate/eliminate risk, direct and communicate highly complex projects, initiatives and/or 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 including but not limited to:

• Ensure on time execution of clinical trials in accordance with global clinical processes, regulations and good clinical practices.

• Effectively partner with internal team members to drive clinical trial success across multiple functions

• Provide strategic leadership and direction including the development and maintenance of significant KOL relationships

• Key stakeholder in Scientific Communication activities: clinical data reports, presentations for Regulatory submissions, conferences and study meetings (e.g., Executive Committees, DSMB, CEC, Steering Committees) and ensure accuracy and relevancy.

What you will need (Required)

• Bachelor's Degree in in scientific or related discipline with related experience including clinical strategy

• Demonstrated track record in people management with ability to effectively lead and manage a diverse team across multiple geographies

• Experience with Class II & III medical devices preferred, documented current continuing education in clinical research monitoring or experience in Clinical Research

• Proven experience in effectively working with Investigators, physicians and site study teams.

What else we look for (Preferred)

• Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas strongly preferred

• Experience in managing Pivotal and Post Approval clinical trials in the US and Europe.

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

• Provide leadership and direction to large cross-functional teams to successfully implement global enterprise systems and related solutions

• Proven successful project management leadership skills with ability to meet deadlines on multiple projects

• Expert understanding of clinical regulations/guidelines and procedures (e.g., ICH/GCP E6, ISO14155, CFR 820, Canadian Medical Device Regulation (CMDR), EU MDD/MDR) while looking beyond existing methodologies and own discipline to define and resolve complex problems

• Excellent financial and business acumen

• Expert understanding and application of industry best practices

• 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 affairs to the business

• Serves as core partner to senior leaders in Business Units, Functional Groups, and Regions

• Understanding concepts of biostatistical and actuarial methods

• Fully comply with all US and Global regulations, and SOPs in the execution of all job duties

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $209,000 - $296,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world‑class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient‑focused culture to deliver life‑changing innovations to those who need them most.