Position Summary:
Responsible for translating clinical operations needs into AI-driven solutions and leading the strategy, implementation, and scaling of AI to enhance clinical trial execution and performance. Embeds AI into day-to-day Clinical Development Operations to improve study delivery, site performance, patient enrollment/engagement/retention, and data quality.
Job Responsibilities:
- Develop and execute an AI integration roadmap/framework across Clinical Development Operations (prioritizing high-impact areas)
- Identify/prioritize AI use cases (e.g., site activation, enrollment, monitoring, issue detection) and embed tools into CTM/CRA workflows
- Define and track KPIs to measure ROI of AI implementations
- Collaborate cross-functionally (Clinical, Clinical Science, IT, Quality, Regulatory, etc.) to align and integrate initiatives
- Oversee vendor evaluation/selection/management for AI-enabled clinical technologies; ensure validated, actionable outputs
- Drive knowledge transfer, adoption (training/change management/stakeholder engagement), and best practices
- Establish SOPs and governance for AI use (validation, performance monitoring, documentation)
- Ensure compliance with GCP/GxP, regulatory requirements, and internal quality standards
- Assess emerging technologies and recommend innovations
- Remote work may be available; HQ visit required ~1 week/month
Education/Qualifications:
- BS or advanced degree in Life Sciences, Computer Science, Data Science, or technical field
- 8+ years in pharma/biotech/CRO; 5+ years in AI/ML, advanced analytics, or digital health
- Experience leading/participating in AI projects in clinical/biomedical domains
- Ability to translate clinical trial processes into AI solutions
- Background in AI/ML/data science with practical clinical applications
- Strong communication and cross-functional collaboration skills
- Familiarity with regulatory compliance for AI in clinical trials
Skills/Additional:
- Contribute to innovation and change in a matrixed organization