About the role

  • 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
  • flexible paid time off (PTO) and sick time
  • career development and progression
  • supportive and engaged line management
  • technical and therapeutic area training
  • peer recognition and total rewards program

Job title

Director, AI Solutions

Job type

Experience level

Lead

Salary

Not specified

Degree requirement

Postgraduate Degree

Location requirements

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