

New · posted Nov 1
Edwards Lifesciences · Medical Devices
Senior Director, Clinical Affairs
- Irvine, CA
- On-site
- Full-time
- Director
The role
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 need
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)nice to have
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). Applications will be accepted while this position is posted on our Careers website.
Pay and benefits
$209,000 – $296,000 a year
Employer providedCompetitive salaries
Performance-based incentives
Wide variety of benefits programs
Where you'll work
Irvine, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Irvine, CAEqual opportunity, accessibility and legal noticesEdwards Lifesciences's statements, word for word
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 17% above the US median for Clinical Affairs roles at this level.
This roleEmployer provided
Director roles in the US5 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $209,000 | — | $296,000 |
| All US (middle half) | $197,000 | $216,000 | $238,500 |
This role: Edwards Lifesciences's own published range. Comparisons: the base pay employers published on open Clinical Affairs roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Affairs
The general path across 18 open Clinical Affairs roles on Regulatory Jobs, with the titles they carry most. Not Edwards Lifesciences's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership13
- Clinical trial conduct8
- Documentation and SOPs5
- GMP and compliance3
- Lab testing and methods3
- Investigations and CAPA2
- Regulatory submissions2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
Company hiring pulse
Edwards Lifesciences on Regulatory Jobs
- 31
- Open roles
- 30
- Distinct roles
- 6
- Locations
By discipline
- Quality18 58%
- Regulatory7 23%
- Clinical6 19%
By level
- Senior & Principal20 65%
- Associate & Specialist6 19%
- Director3 10%
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Senior Director, Clinical Affairs at Edwards Lifesciences
Open until filled. $209K–$296K a year, employer provided.

