Director, AI Clinical Operations & Regulatory
Core
Leading AI-enabled transformation in clinical development and regulatory operations to accelerate trials, enhance safety workflows, and automate submissions.
Role type
Director, AI Clinical Operations & Regulatory
Builds
AI-driven trial acceleration workflows, automated clinical safety operations, and streamlined regulatory submission processes
Domain
Biopharma/Medtech clinical operations and regulatory affairs
Deliverable
production ML models | product features
Required skills
Clinical development operations leadership, regulatory operations expertise, AI workflow transformation, FDA submission experience, pharmacovigilance case processing, signal detection, vendor/platform validation, stakeholder negotiation
Preferred skills
NLP for document automation, AI-enabled patient recruitment, ICH E6(R3) knowledge, multi-therapy unit AI tooling consolidation, biopharma trial operations experience
Technologies
Medidata Rave, Veeva Vault CTMS, Oracle Argus Safety, ArisGlobal LifeSphere, Veeva Vault Safety
Responsibilities
Lead AI-enabled transformation for trial acceleration, own AI for clinical safety operations, lead AI-enabled regulatory operations transformation, validate vendor and platform investments, co-sign cycle-time commitments, work with Medical/Clinical/Regulatory teams for protocol design
Seniority
Director, strategic leadership & execution
