Director, Clinical AI

Edwards Lifesciences • Alton, IL

4d

About The Position

Innovation starts from the heart. Our Advanced Innovation & Technology (AI&T) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AI&T team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology. The Director, Clinical AI will be responsible for leading the strategy, development, validation, and deployment of AI/ML solutions that support clinical development, medical affairs, and clinical decision making across the enterprise. This role serves as a bridge between clinical science, data science, digital product development, and regulatory functions to ensure AI solutions are clinically meaningful, scientifically valid, compliant, and scalable. You will make an impact by: Partners closely with Clinical Affairs, Medical Affairs, R&D, Regulatory Affairs, Quality, Data Science, and Digital Technology teams to drive product and process innovation while maintaining the highest standards of patient safety, data integrity, and regulatory compliance Strategic Leadership: Define and execute the roadmap for AI-driven clinical capabilities, including generative AI, NLP, and predictive analytics Plans and directs complex AI projects with large scale or significant business impact with accountability for successful completion of all project deliverables with appropriate quality objectives Lead in identifying risk, developing mitigation strategies, alternative solutions and resolving issues in a collaboration with cross functional groups Clinical Integration: Collaborate with clinical, data science, and product teams to translate clinical needs into technical specifications and actionable AI solutions. Product Development: Oversee the end-to-end lifecycle of clinical AI products, from prototyping and validation to deployment and monitoring Stakeholder Management: Serve as a subject matter expert, communicating with senior leadership and key stakeholders to drive adoption and demonstrate ROI. Compliance & Governance: Ensure all AI tools adhere to regulatory standards (FDA/EMA), data privacy (GDPR/HIPAA), and ethical guidelines

Requirements

• Bachelor's Degree in related field
• 12 years’ experience in healthcare, biotechnology, or pharma, with significant experience in AI/ML applications and clinical development

Nice To Haves

• Ph.D. or equivalent in Advanced degree (PhD, MD, or MS) in Computer Science, Data Science, Bioinformatics, or a related clinical field.
• 10 years’ experience healthcare, biotechnology, or pharma, with significant experience in AI/ML applications and clinical development
• Proven ability in applying advanced analytics, computer vision, or NLP to clinical, imaging, or drug development datasets
• Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Expert understanding of clinical studies procedures while identifying applications of functional knowledge and existing methodologies to complex problems
• Expert understanding of related aspects of processes and/or systems
• Proven track record in developing and maintaining relationships with internal and external stakeholders
• Proven successful project management leadership skills
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Expert understanding of business strategy, competitive landscape, regulatory environment, and clinical data while looking beyond existing methodologies and own discipline to define and resolve complex problems
• In-depth understanding of cardiovascular diseases and therapies
• Strong experience in cross-functional team leadership, strategic planning, and managing high-stakes technical projects
• Practical knowledge of clinical and biostatics senior level leaders regarding matters of significance to the organization

Responsibilities

• Partners closely with Clinical Affairs, Medical Affairs, R&D, Regulatory Affairs, Quality, Data Science, and Digital Technology teams to drive product and process innovation while maintaining the highest standards of patient safety, data integrity, and regulatory compliance
• Strategic Leadership: Define and execute the roadmap for AI-driven clinical capabilities, including generative AI, NLP, and predictive analytics
• Plans and directs complex AI projects with large scale or significant business impact with accountability for successful completion of all project deliverables with appropriate quality objectives
• Lead in identifying risk, developing mitigation strategies, alternative solutions and resolving issues in a collaboration with cross functional groups
• Clinical Integration: Collaborate with clinical, data science, and product teams to translate clinical needs into technical specifications and actionable AI solutions.
• Product Development: Oversee the end-to-end lifecycle of clinical AI products, from prototyping and validation to deployment and monitoring
• Stakeholder Management: Serve as a subject matter expert, communicating with senior leadership and key stakeholders to drive adoption and demonstrate ROI.
• Compliance & Governance: Ensure all AI tools adhere to regulatory standards (FDA/EMA), data privacy (GDPR/HIPAA), and ethical guidelines

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees