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, and regulatory requirements.
Experience translating complex scientific or operational challenges into scalable technology-enabled solutions.
Excellent communication and executive influencing skills.

Preferred Qualifications

Expertise in Clinical Development, Oncology, Regulatory Science, Data Science, or Clinical Informatics.
Experience developing and deploying Large Language Models (LLMs), Generative AI, Agentic AI systems, or workflow automation platforms in regulated environments.
Experience in Oncology
Familiarity with emerging regulatory frameworks governing AI-enabled drug development.
Experience interacting with global regulatory agencies (e.g. FDA, EMA, MHRA, PMDA, Health Canada
Experience leading enterprise AI transformation initiatives.
Strong publication record and scientific credibility within clinical research and AI innovation.
Experience building and leading high-performing teams.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Physical/Mental Requirements

None

Non-standard Work Schedule, Travel Or Environment Requirements

Occasional travel may be required

WORK LOCATION ASSIGNMENT: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.

The annual base salary for this position ranges from $176,600.00 to $294,300.00. In addition, this position is eligible