AI-Driven Clinical Operations & Regulatory Director

Edwards Lifesciences; Irvine, Northern (CA, KY); Hybrid; USD 202,000 - 287,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking an executive to lead AI-enabled transformation across clinical development, safety, and regulatory operations. You will co-own cycle-time and quality improvements and mobilize cross-functional teams to deliver scalable processes.

This role focuses on trial acceleration, safety workflows, and submission automation, with collaboration across Medical, Clinical & Regulatory groups.

Qualifications

• Degree and 10+ years in clinical development operations or equivalent leadership.
• Proven redesign of workflows with measurable adoption and cycle-time gains.
• Direct experience closing a database lock and supporting FDA submissions.
• Experience with AI-driven pharmacovigilance and signal detection.

Responsibilities

• Lead AI-enabled transformation for trial acceleration and protocol drafting.
• Own AI for clinical safety operations, including adverse event processing.
• Lead AI-enabled regulatory operations transformation and submission workflows.
• Validate and reconcile existing vendor investments across clinical systems.
• Co-sign cycle-time commitments with Clinical Affairs, Biometrics, and Regulatory leadership.
• Collaborate with Medical, Clinical & Regulatory teams on protocol design.

Skills

Clinical operations

Leadership

FDA submission

AI in pharmacovigilance

Regulatory workflows

Education

Bachelor's Degree in related discipline

Master's Degree (or PhD) in related field

Tools

Medidata Rave

Veeva Vault CTMS

Oracle Argus Safety

Veeva Vault Safety

Job description

Edwards Lifesciences in Irvine, CA is seeking an executive to lead AI-enabled transformation across clinical development, safety, and regulatory operations. You will co-own cycle-time and quality improvements and mobilize cross-functional teams to deliver scalable processes.

This role focuses on trial acceleration, safety workflows, and submission automation, with collaboration across Medical, Clinical & Regulatory groups.