Syneos Health, Inc.
Director, AI Solutions
Syneos Health, Inc., Morrisville, North Carolina, United States, 27560
Overview
Updated: September 21, 2025 Location: USA-NC-Morrisville-Hybrid Job ID: 25101711 Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we aim to work better together as one team, with each member the best at what they do. We bring a wide range of experts across critical services to support our business. All roles within Corporate are vital to shortening the distance from Lab to Life. Discover what our 29,000 employees across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people through career development and progression; supportive line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture where you can authentically be yourself and feel cared for as part of a global community. We value diversity of thoughts, backgrounds, cultures and perspectives to create a sense of belonging for everyone. Job Responsibilities
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. Qualifications
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. Experience Requirements
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. KPIs & Success Metrics
Reduce 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 Skills
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. Benefits and Compensation
We offer a comprehensive benefits package including health benefits (medical, dental, vision), 401(k) with company match, eligibility for Employee Stock Purchase Plan, potential bonuses, and paid time off. Paid sick time varies by location in compliance with local regulations. Syneos complies with applicable laws regarding paid leave. Get to know Syneos Health
Over the past 5 years, we have worked with 94% of novel FDA approved drugs, 95% of EMA authorized products, and conducted 200+ studies across 73,000 sites and 675,000+ trial patients. Learn more about Syneos Health at http://www.syneoshealth.com Equality information: Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you require reasonable accommodation to complete the application process, please contact jobs@syneoshealth.com.
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Updated: September 21, 2025 Location: USA-NC-Morrisville-Hybrid Job ID: 25101711 Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we aim to work better together as one team, with each member the best at what they do. We bring a wide range of experts across critical services to support our business. All roles within Corporate are vital to shortening the distance from Lab to Life. Discover what our 29,000 employees across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people through career development and progression; supportive line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture where you can authentically be yourself and feel cared for as part of a global community. We value diversity of thoughts, backgrounds, cultures and perspectives to create a sense of belonging for everyone. Job Responsibilities
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. Qualifications
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. Experience Requirements
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. KPIs & Success Metrics
Reduce 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 Skills
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. Benefits and Compensation
We offer a comprehensive benefits package including health benefits (medical, dental, vision), 401(k) with company match, eligibility for Employee Stock Purchase Plan, potential bonuses, and paid time off. Paid sick time varies by location in compliance with local regulations. Syneos complies with applicable laws regarding paid leave. Get to know Syneos Health
Over the past 5 years, we have worked with 94% of novel FDA approved drugs, 95% of EMA authorized products, and conducted 200+ studies across 73,000 sites and 675,000+ trial patients. Learn more about Syneos Health at http://www.syneoshealth.com Equality information: Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you require reasonable accommodation to complete the application process, please contact jobs@syneoshealth.com.
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