Director, AI Clinical Operations & Regulatory
About the role
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. How you will make an impact: This role will play a pivotal role in leading AI-enabled transformation across Edwards' clinical development and regulatory operations, with initial emphasis on trial acceleration, clinical safety workflows, and submission automation. It does not replace the accountable Clinical Affairs, Safety, Biometrics, or Regulatory functions. It shapes the transformation agenda, co-owns measurable cycle-time and quality outcomes with those leaders, and mobilizes product, data, engineering, and change capabilities to deliver them.
Responsibilities
- Lead AI-enabled transformation for trial acceleration, including protocol and statistical analysis plan drafting, EMR-to-CRF integration, monitoring and alerting, enrollment intelligence, and operating-model redesign
- Own AI