Director, AI-Driven Clinical Ops & Regulatory

Edwards Lifesciences Gruppe

Irvine (CA)

On-site

USD 202,000 - 287,000

Full time

5 days ago

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Job summary

Edwards Lifesciences Gruppe seeks a senior leader to drive AI-enabled transformation across clinical development operations, regulatory workflows, and safety monitoring. You will partner with Medical, Clinical & Regulatory teams to redesign processes for faster, safer outcomes.

This role requires extensive experience with FDA submissions, protocol design, and leveraging NLP/AI tools to accelerate trials and automate safety reporting in a regulated environment.

Qualifications

12 years of experience in clinical development operations, data management, biometrics, or regulatory operations, or equivalent leadership at a clinical technology vendor or CRO.
Experience closing a database lock and supporting at least one FDA regulatory submission.
Experience with AI-driven pharmacovigilance case processing and signal detection.

Responsibilities

Lead AI-enabled transformation for trial acceleration, including protocol drafting and EMR-to-CRF integration.
Own AI for clinical safety operations, including adverse event extraction and signal detection.
Lead AI-enabled regulatory operations transformation, including submission section drafting and evidence packaging.

Skills

AI-enabled transformation

Regulatory submissions

Clinical development operations

Project leadership

Education

Bachelor's Degree in related discipline

Master’s degree or PhD in a related field

Tools

Medidata Rave

Veeva Vault CTMS

Job description

This role requires extensive experience with FDA submissions, protocol design, and leveraging NLP/AI tools to accelerate trials and automate safety reporting in a regulated environment.

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