AI Clinical Leader

Main Responsibilities

• Partner with clinical development, medical, biostatistics, data management, and clinical operations teams to identify and deliver AI use cases across the clinical trial lifecycle.

• Develop AI/ML solutions to support protocol optimization, site selection, patient recruitment, enrollment forecasting, trial monitoring, and risk-based quality management.

• Apply NLP, predictive analytics, and generative AI to clinical documents, trial data review, safety narratives, and operational insights generation.

• Support real-world data and real-world evidence analytics to improve clinical strategy, patient stratification, and evidence generation.

• Collaborate with cross-functional teams to integrate AI tools with EDC, CTMS, eTMF, safety, and other clinical systems.

• Ensure AI applications in clinical development comply with GCP, privacy requirements, validation standards, and internal governance policies.

• Establish metrics to evaluate AI impact on trial speed, quality, cost, patient diversity, and operational efficiency

Required Skills

• 8+ years of experience in clinical data science, clinical technology, AI/ML, or digital clinical development within pharmaceutical, biotech, or CRO environments.

• Demonstrated experience applying advanced analytics or AI to clinical trial operations, clinical data, or real-world evidence.

• Advanced degree (MS/PhD preferred) in Data Science, Biostatistics, Computer Science, Life Sciences, Public Health, or related field.

• Expertise in AI/ML methods, NLP, predictive modeling, and analytics tools relevant to clinical development.

• Familiarity with clinical systems and standards such as EDC, CTMS, eTMF, CDISC, and real-world data platforms.

• Strong understanding of clinical trial design, operations, data management, GCP, and regulatory expectations in clinical development.

• Strong leadership, problem-solving, communication, and cross-functional collaboration skills.

• Excellent leadership, architecture governance, communication, and stakeholder management capabilities.