Head of AI Clinical Excellence

ROLE SUMMARY

You will serve as the hands-on, proactive, strategic leader responsible for advancing the application of Artificial Intelligence (AI) across the Clinical Development lifecycle. You will partner closely with the Oncology Clinical Development, Clinical Operations, Biostatistics, Data Science, Medical Affairs, Regulatory Affairs, and Digital organizations to identify, develop, and scale AI-driven capabilities that improve trial design, data review, study execution, operational efficiency, decision-making, and regulatory readiness.

You will leverage your deep expertise in Clinical Development with your proven track record of delivering AI-enabled solutions in pharmaceutical research and development environments including your experience interacting with regulatory agencies on implementation of AI solutions in clinical development.

ROLE RESPONSIBILITIES

Strategic AI Leadership

• Develop and accountable to execute the enterprise strategy for AI-enabled Clinical Excellence across Clinical Development.

• Identify high-value opportunities to accelerate development timelines, improve quality, reduce operational burden, and enhance decision-making through AI.

• Serve as a trusted advisor to senior leaders on emerging AI capabilities, industry trends, and competitive advancements.

Clinical Development Innovation

• Drive adoption of AI solutions across study design, protocol optimization, feasibility assessments, patient recruitment, trial execution, and clinical data review.

• Lead development of AI-enabled approaches to improve clinical trial performance, operational excellence, and portfolio decision-making.

• Enable predictive and prescriptive analytics to support program-level and study-level decisions.

AI Product Development and Deployment

• Partner with digital, data science, and technology teams to design, build, validate, and deploy AI-powered tools and platforms.

• Establish frameworks for scalable AI solutions that integrate into existing clinical development workflows.

• Responsible for the development of agentic AI, generative AI, predictive analytics, and workflow automation solutions supporting clinical operations and development teams.

Regulatory and Governance Leadership

• Provide subject matter expertise on global regulatory expectations for AI, machine learning, and advanced analytics within drug development.

• Partner with Regulatory Affairs and Quality organizations to establish AI governance frameworks, validation approaches, and risk management processes.

• Monitor evolving health authority guidance and industry standards related to AI-enabled development activities.

Cross-Functional Leadership

• Build strong partnerships across the Oncology Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, Medical, Safety, and Digital organizations.

• Lead multidisciplinary teams responsible for AI innovation initiatives.

• Drive organizational adoption through education, change management, and capability building.

External Engagement

• Represent the organization in industry forums, consortiums, health authority interactions, and scientific conferences related to AI and Clinical Development innovation.

• Build relationships with key external partners, technology providers, and academic collaborators.

MINIMUM QUALIFICATIONS

• MD and  4+ years of relevant experience within pharmaceutical, biotechnology, CRO, regulatory, or healthcare organizations OR

• PhD in Life Sciences, Clinical Research, Data Science, Biostatistics, Computer Science, Engineering, or related field and 5+ years of relevant experience within pharmaceutical, biotechnology, CRO, regulatory, or healthcare organizations OR

• MS  in Life Sciences, Clinical Research, Data Science, Biostatistics, Computer Science, Engineering, or related field and 7+ years of relevant experience within pharmaceutical, biotechnology, CRO, regulatory, or healthcare organizations.

• Experience designing, developing, and implementing AI, machine learning, or advanced analytics solutions in clinical research settings.

• Experience supporting Clinical Development, Clinical Operations, Clinical Science, Clinical Data Review, or Regulatory Science activities.

• Experience leading cross-functional programs involving clinical, regulatory, scientific, and technical stakeholders.

• Strong understanding of GCP, clinical trial conduct, drug development processes, an