Senior Product Leader, Regulated AI & Protocols

Regeneron Pharmaceuticals, Inc (USA); Kentucky; On-site; USD 180,000 - 240,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks an experienced Global Development IT Associate Director/Product Lead to drive strategy, delivery, and continuous improvement for a portfolio including protocol digitization, biospecimen and AI orchestration.

You will lead a team of Product Leads and Analysts, shape the domain vision, and partner with stakeholders across BSPs, SMEs, and IT to translate enterprise priorities into scalable capabilities with strong governance and compliance.

Qualifications

• Experience leading domain-level product ownership in regulated environments.
• Experience with USDM/ICH M11, CDISC SDTM/ADaM and related governance.
• Ability to influence senior leaders and manage cross-functional stakeholders.

Responsibilities

• Own domain product portfolio, including end-to-end implementation and lifecycle management.
• Lead and develop teams of Product Leads and Product Analysts.
• Set domain strategy, roadmap, and governance forums for alignment and reuse.
• Manage requirements, testing, risk, and release processes to ensure audit readiness.
• Collaborate with GD IT, Corporate IT, and vendors to translate priorities into capabilities.

Skills

Domain ownership

Stakeholder management

Regulatory compliance

AI governance

Education

Bachelor's degree in a related field

Tools

LIMS/LIS integrations

EDC systems

REST/GraphQL APIs

Cloud platforms

Job description

Regeneron Pharmaceuticals, Inc. seeks an experienced Global Development IT Associate Director/Product Lead to drive strategy, delivery, and continuous improvement for a portfolio including protocol digitization, biospecimen and AI orchestration.

You will lead a team of Product Leads and Analysts, shape the domain vision, and partner with stakeholders across BSPs, SMEs, and IT to translate enterprise priorities into scalable capabilities with strong governance and compliance.