Director, AI Solutions

OverviewDirector, 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, and strong knowledge of regulatory frameworks (ICH-GCP, FDA, EMA).ResponsibilitiesDefine 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 municate 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.QualificationsMaster’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.Experience10+ 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.KPIs & Success MetricsReduce patient recruitment timelines using AI-driven matching and outreach.Shorten trial start-up time through AI-enabled site and country selection.Achieve quality improvements and reduction in protocol deviations through predictive analytics.Improve compliance metrics with ICH-GCP and regulatory audit standards.Deliver cost savings annually through AI-driven process optimization across the clinical development lifecycle.Achieve strong adoption rate of AI tools across enterprise teams within 12–24 months.Positively influence sponsor satisfaction score for AI-enabled trial delivery.Preferred SkillsExperience 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.Benefits & Additional InformationThe position offers benefits such as health coverage, retirement plans, and paid time off where permitted by law. Actual benefits may vary by location.SalaryThe base salary range represents the anticipated range for this position. Actual salary will vary based on qualifications, skills, and proficiency. #J-18808-Ljbffr

Created: 2025-09-25