Define and execute the AI roadmap for clinical research and trials, aligned with CRO business objectives
Identify AI opportunities in patient recruitment, site selection, risk-based monitoring, and real-world evidence analytics
Lead the design and deployment of AI/ML models for predictive enrollment, protocol optimization, and adverse event detection
Ensure solutions comply with GxP, HIPAA, GDPR, and global regulatory requirements
Partner with clinical operations, data management, and biostatistics teams to integrate AI into trial workflows
Communicate AI-driven insights to sponsors and regulatory bodies in a clear, compliant manner
Establish best practices for ethical AI in clinical research, ensuring transparency and audit readiness
Implement robust model validation, monitoring, and lifecycle management processes
Build and mentor a team of AI engineers, data scientists, and clinical informatics specialists
Foster a culture of innovation and regulatory compliance
Measure success via KPIs: reduce patient recruitment timelines, shorten trial start-up time, improve quality and compliance metrics, deliver cost savings, drive AI tool adoption and sponsor satisfaction
Requirements
Master’s or Ph.D. in Computer Science, Data Science, Life Sciences, or related field
clinical research experience preferred
Strong understanding of AI/ML algorithms, clinical trial design, and healthcare data standards (CDISC, SDTM, ADaM)
Proven ability to deliver AI and Generative AI solutions in regulated environments
Excellent leadership, communication, and stakeholder management skills
10+ years in technology leadership roles
At least 5 years focused on AI/ML in clinical research or life sciences
Demonstrated success in deploying AI for clinical operations, centralized monitoring, patient recruitment, site feasibility, clinical data management, trial optimization
Experience with EDC systems (Medidata, Oracle Clinical)
Experience with clinical data warehouses and cloud platforms (AWS, Azure)
Familiarity with regulatory submissions and audit processes
Knowledge of GxP, HIPAA, GDPR compliance requirements
Preferred: NLP for clinical documents and trial protocols
Preferred: AI applications in pharmacovigilance, safety signal detection, RWE analytics, decentralized clinical trials and digital health technologies
Familiarity with regulatory AI guidance from FDA, EMA, EU AI Act and other global guidances
Benefits
company car or car allowance
Health benefits to include Medical, Dental and Vision
Company match 401k
eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
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