Director, AI Clinical Operations & Regulatory
Edwards Lifesciences · Irvine, CA
RegulatoryFull-time$202k–$287kCompany career page
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Role summary
Edwards Lifesciences seeks a Director to lead AI-driven transformation across clinical development and regulatory operations. The role focuses on trial acceleration, clinical safety workflows, and submission automation while collaborating with existing Clinical Affairs, Safety, and Regulatory leadership.
What they're looking for
- Bachelor's degree in related field with 12 years clinical/regulatory operations experience, or Master's/PhD with 10 years equivalent experience
- Demonstrated record of redesigning clinical or regulatory workflows with measurable improvements in adoption, cycle-time, or quality
- Direct personal experience closing a database lock and supporting at least one FDA regulatory submission
- Experience with AI-driven pharmacovigilance case processing and signal detection from biopharma, CRO, or safety-technology vendor
- Working knowledge of major CTMS and clinical data platforms such as Medidata Rave or Veeva Vault
- Ability to negotiate and co-sign commitments with senior Clinical Affairs and Regulatory leadership across multiple therapy areas
What you'll be doing
- Lead AI-enabled transformation for trial acceleration including protocol drafting, EMR-to-CRF integration, enrollment intelligence, and operating-model redesign
- Own AI for clinical safety operations including adverse event extraction, signal detection, and safety committee packet generation
- Lead AI-enabled regulatory operations transformation including submission section drafting, evidence packaging, and adoption controls
- Validate and reconcile existing vendor and platform investments across clinical systems and co-sign cycle-time commitments with leadership
- Collaborate with Medical, Clinical, and Regulatory teams on protocol and trial design; mobilize product, data, and engineering capabilities
Privacy & handoff
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