Irvine, California, United States · On-site
$209k–$296k/yr
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 …
Skills: Clinical affairs, Clinical trial management, People leadership, Strategic planning, Budgeting
Irvine, California, United States · On-site
$70k–$99k/yr
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. For more than 50 years, we have established a remarkable tr…
Skills: Hardware Troubleshooting, Software Troubleshooting, Device Deployment, Endpoint Management, Active Directory
Irvine, California, United States · On-site
$92k–$13k/yr
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments…
Skills: Regulatory affairs, Medical devices, Regulatory submissions, PMA, 510(k)
Cartago, Costa Rica · On-site
Innovation starts from the heart. At Edwards Lifesciences, we’re dedicated to developing ground-breaking technologies with a genuine impact on patients’ lives. At the core of this commitment is our investment in cutting-…
Skills: Identity & Access Management, SSO/Federation, MFA, Identity Governance, Privileged Access Management
Irvine, California, United States · On-site
$121k–$171k/yr
Innovation starts from the heart. At Edwards Lifesciences, we’re dedicated to developing ground-breaking technologies with a genuine impact on patients’ lives. At the core of this commitment is our investment in cutting-…
Skills: AI/ML Product Management, Software Engineering, System Design, MLOps, Generative AI
Irvine, California, United States · On-site
$105k–$148k/yr
Imagine how your ideas and expertise can change a patient’s life. Patients are at the heart of what we do at Edwards Lifesciences. Our Finance teams work hard to optimize our current and long-term success and enable our …
Skills: Financial Planning and Analysis, Financial Modeling, Budgeting, Forecasting, Month-end Close
Texas, United States · Remote OK
$139k–$196k/yr
Sr. Manager, Professional Education Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreak…
Skills: Professional Education Strategy, Project Management, KOL Engagement, Curriculum Development, Vendor Management
Irvine, California, United States · On-site
$108k–$153k/yr
Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner c…
Skills: Quality Engineering, CAPA, Six Sigma, Lean Methods, Risk Management
Irvine, California, United States · On-site
$121k–$171k/yr
Imagine how your ideas and expertise can change a patient’s life. Patients are at the heart of what we do at Edwards Lifesciences. Our Finance teams work hard to optimize our current and long-term success and enable our …
Skills: Financial Planning, Forecasting, Financial Reporting, Decision Support, Variance Analysis
Irvine, California, United States · On-site
$134k–$190k/yr
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative …
Skills: Clinical Education, Procedural Innovation, Clinical Imaging, Cardiovascular Anatomy, Medical Device Regulatory Requirements
Scranton, Pennsylvania, United States · On-site
Make a meaningful difference to patients around the world. As a part of the Field Clinical Specialist team, you will be a critical part of delivering our patient focused innovations, partnering with clinical professional…
Skills: Clinical Training, Case Management, Valve Crimping, Interventional Cardiology, Cardiac Surgery
Caesarea, Haifa District, Israel · On-site
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each…
Skills: Procurement, Supply Chain Planning, Supplier Negotiation, MRP, ERP Systems
Irvine, California, United States · On-site
$121k–$171k/yr
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 …
Skills: Clinical Operations Management, Project Management, Budget Management, Vendor Management, Performance Metrics
pune, Maharashtra, India · On-site
Edwards Lifesciences is expanding its global technology capabilities with the launch of a new IT Innovation Hub in Pune, India. The Hub strengthens the technology foundation that supports our business worldwide, working …
Skills: Microsoft Intune, Microsoft Configuration Manager (SCCM), Windows Autopilot, Jamf Pro, PowerShell
Irvine, California, United States · On-site
$139k–$196k/yr
Innovation starts from the heart. Heart valve disease impact millions of lives, spanning all ages and geographies. As communities globally address the opportunities and challenges of cardiovascular care, telling a compel…
Skills: Product Marketing, Team Management, Strategic Planning, KOL Relationship Management, Customer Engagement
Draper, Utah, United States · On-site
Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standard…
Skills: Visual Inspection, Dimensional Inspection, Functional Testing, Microscope Operation, SOP Compliance
Singapore, Singapore · On-site
Applies skill and dexterity in the sewing of tissue and non-tissue components used to produce medical devices, in keeping with regulatory and company guidelines. Key Responsibilities: • Use tools (e.g. needles, scissors,…
Skills: Manual dexterity, Hand-eye coordination, Microscope operation, Sewing, Medical device assembly
Draper, Utah, United States · On-site
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each…
Skills: Quality Engineering, CAPA, NCR Management, Process Validation, Six Sigma
Irvine, California, United States · On-site
$173k–$245k/yr
Imagine how your ideas and expertise can change a patient’s life. Patients are at the heart of what we do at Edwards Lifesciences. Our Finance teams work hard to optimize our current and long-term success and enable our …
Skills: Strategic Business Partnership, Financial Planning, Performance Management, Revenue Planning, Market Analytics
pune, Maharashtra, India · On-site
Edwards Lifesciences is expanding its global technology capabilities with the launch of a new IT Innovation Hub in Pune, India. The Hub strengthens the technology foundation that supports our business worldwide, working …
Skills: Microsoft Copilot, Moveworks, Solution Architecture, Integration Architecture, Agentic AI
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The Senior Director of Clinical Affairs will lead global clinical studies and provide strategic leadership for new and marketed product development. They are responsible for managing clinical activities, budgets, and cross-functional teams while ensuring compliance with global regulations and clinical standards.
Candidates must possess a Bachelor's degree in a scientific discipline and extensive experience in clinical strategy and people management. Proven expertise in Class II and III medical devices and a strong track record of working with investigators and regulatory authorities are required.
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.
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.
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.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Global leader in the medical device industry with a patient-focused culture of innovation
Edwards Lifesciences (NYSE: EW), 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. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Contact Us We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm. All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.
Offices: One Edwards Way, Irvine, CA 92614, US · 12050 S Lone Peak Pkwy, Draper, Utah 84020, US · 1919 Minnesota Crt, Mississauga, Ontario L5N 0C9, CA · Parque Industrial de Itabo, Carr. Sanchez, Km 18.5 Zona Franca Industrial de Haina, Haina, San Cristobal, DO · State Road 402 North, Km 1.4, Industrial Park, Añasco, 00610-1577, PR
Global leader in the medical device industry with a patient-focused culture of innovation
Edwards Lifesciences (NYSE: EW), 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. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Contact Us We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm. All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.
Offices: One Edwards Way, Irvine, CA 92614, US · 12050 S Lone Peak Pkwy, Draper, Utah 84020, US · 1919 Minnesota Crt, Mississauga, Ontario L5N 0C9, CA · Parque Industrial de Itabo, Carr. Sanchez, Km 18.5 Zona Franca Industrial de Haina, Haina, San Cristobal, DO · State Road 402 North, Km 1.4, Industrial Park, Añasco, 00610-1577, PR
