Director, AI Clinical Operations & Regulatory

Key Responsibilities

• Lead AI-enabled transformation for trial acceleration, including protocol and statistical analysis plan drafting, EMR-to-CRF integration, monitoring and alerting, enrollment intelligence, and operating-model redesign
• Own AI for clinical safety operations, including adverse event extraction and adjudication, signal detection, and safety committee packet generation
• Lead AI-enabled regulatory operations transformation, including submission section drafting, evidence packaging, review workflows, and adoption controls
• Validate and reconcile existing vendor and platform investments across clinical systems
• Co-sign cycle-time commitments with Clinical Affairs, Biometrics, and Regulatory leadership
• Work with Medical, Clinical & Regulatory teams for protocol and trial design
• Other incidental duties

What you'll need (Required)

• Bachelor's Degree in related discipline, with 12 years of experience in clinical development operations, data management, biometrics, or regulatory operations, or equivalent leadership at a clinical technology vendor or CRO -OR- Master's, PhD, or other advanced degree with 10 years of experience in clinical development operations, data management, biometrics, or regulatory operations, or equivalent leadership at a clinical technology vendor or CRO
• A record of redesigning clinical or regulatory workflows and achieving measurable adoption, cycle-time, quality, or productivity improvements
• 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, gained at a biopharma company, CRO, or safety-technology vendor

What else we look for (Preferred)

• Certification in related field
• Building and defending a benefits case under Finance-level scrutiny
• Negotiating and co-signing commitments directly with senior Clinical Affairs and Regulatory leadership across multiple therapy areas
• Working fluency with major CTMS and clinical data platforms (Medidata Rave, Veeva Vault CTMS, or equivalent) and Good Clinical Practice (GCP) requirements
• Familiarity with natural-language and document-automation tooling applied to protocols, statistical analysis plans, or safety narratives
• Direct exposure to AI-enabled pharmacovigilance platforms (Oracle Argus Safety, ArisGlobal LifeSphere, or Veeva Vault Safety) and their AI-driven case intake, MedDRA coding, and signal-scoring capabilities
• Familiarity with AI-driven patient recruitment and site-selection approaches from biopharma trial operations: NLP-based EHR mining for eligibility screening, digital biomarkers and wearable data for continuous safety monitoring, and in silico trial simulation for protocol feasibility testing
• Working knowledge of ICH E6(R3) and its implications for AI-assisted trial oversight
• Experience standing up or consolidating clinical AI tooling across a multi-therapy-unit organization
• Familiarity with major clinical data platforms such as Medidata or Veeva
• Direct biopharma clinical operations experience, where AI adoption in trial acceleration and safety operations is further along than in medtech