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Director, AI Solutions
2 weeks ago
Description
Director, AI Solutions
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 perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of 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 and engaged 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. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.
Job Responsibilities
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.
QUALIFICATION
- 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 clinical development lifecycle of processes
- 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.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
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.
