Director, AI-Driven Clinical Operations & Regulatory

Regulatory Jobs; Irvine (CA); On-site; USD 202,000 - 287,000; Full time

Benefits offered by this job

Competitive salaries

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences is seeking a leader to drive AI-enabled transformation across clinical development and regulatory operations in California. You will shape trial acceleration, safety workflows, and submission automation, collaborating with Medical, Clinical & Regulatory teams.

This senior role demands deep experience in regulatory submissions, AI tooling, and cross-functional leadership. The role interfaces with CTMS and clinical data platforms, including Medidata Rave and Veeva Vault, to

Qualifications

• Bachelor’s degree in a related discipline with 12 years of experience in clinical development operations, data management, biometrics, or regulatory operations, or a Master’s/PhD with 10 years in the same areas
• Proven record redesigning workflows and achieving measurable adoption, cycle-time, quality, or productivity improvements
• Direct experience closing a database lock and supporting at least one FDA regulatory submission
• Experience with AI-driven pharmacovigilance and safety tooling in biopharma or CRO environments

Responsibilities

• Lead AI-enabled transformation for trial acceleration and protocol design
• Own AI for clinical safety operations including adverse event extraction and safety package generation
• Lead AI-enabled regulatory operations transformation including submission drafting and evidence packaging
• Validate and reconcile vendor investments across clinical systems
• Co-sign cycle-time commitments with Clinical Affairs, Biometrics, and Regulatory leadership

Skills

AI transformation leadership

Clinical development operations

Regulatory operations leadership

Data management

FDA submissions

Education

Bachelor's degree + 12 years experience

Master’s/PhD + 10 years experience

Tools

Medidata Rave

Veeva Vault CTMS

Oracle Argus Safety

ArisGlobal LifeSphere

Veeva Vault Safety

Job description

Edwards Lifesciences is seeking a leader to drive AI-enabled transformation across clinical development and regulatory operations in California. You will shape trial acceleration, safety workflows, and submission automation, collaborating with Medical, Clinical & Regulatory teams.

This senior role demands deep experience in regulatory submissions, AI tooling, and cross-functional leadership. The role interfaces with CTMS and clinical data platforms, including Medidata Rave and Veeva Vault, to