Syneos Health-posted 3 months ago
Full-time • Senior
Morrisville, NC
Professional, Scientific, and Technical Services

The Director of AI Solutions - Clinical Research & Trials will lead the strategy, design, and implementation of AI-driven solutions to accelerate clinical trial operations, enhance patient recruitment and retention, optimize protocol design, and improve data quality and compliance. This role requires a visionary leader with deep expertise in artificial intelligence, machine learning, and clinical research processes, combined with strong knowledge of regulatory frameworks (ICH-GCP, FDA, EMA). The Director will collaborate with sponsors, CRO teams, and technology partners to deliver scalable, compliant, and innovative AI solutions that reduce trial timelines and costs while improving patient outcomes.

  • 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.
  • 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, with 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), clinical data warehouses, and cloud platforms (AWS, Azure).
  • Familiarity with regulatory submissions and audit processes.
  • Experience with natural language processing (NLP) for clinical documents and trial protocols.
  • AI applications in enterprise systems, commercial and late phase, clinical monitoring, pharmacovigilance and safety signal detection.
  • Expertise in real-world evidence (RWE) analytics and observational data modeling.
  • Familiarity with decentralized clinical trials and digital health technologies.
  • Knowledge of regulatory AI guidance from FDA, EMA, EU AI Act and other global guidances.
  • Company car or car allowance
  • Health benefits including 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
  • Flexible paid time off (PTO) and sick time
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