Senior Product Lead, Global Development IT & AI

Regeneron; New Jersey; On-site; USD 157,200 - 256,600; Full time

Job summary

Regeneron is seeking a Global Development IT Associate Director, Product Lead to own a portfolio spanning protocol digitization, Digital Data Flow, and biospecimen lifecycle management. Based at our Warren, NJ location, this role requires four days onsite per week and leadership of Product Leads and Analysts.

You will translate enterprise priorities into capabilities, set domain vision, and partner with BSPs, SMEs, Corporate IT, and vendors to deliver compliant, auditable solutions across

Qualifications

• Strong command of ICH M11/USDM and CDISC SDTM/ADaM with regulated governance.
• Delivery of protocol authoring and data automations with traceable lineage.
• Experience with LIMS/LIS integrations and analytics in GxP environments.

Responsibilities

• Lead and develop a team of Product Leads and Analysts across multiple domains.
• Own domain strategy, roadmap, and governance for protocol digitization and data flow.
• Manage stakeholder relationships, budget, and end-to-end product deliveries.
• Oversee CSV validation, test planning, and release processes aligned to 21 CFR Part 11.

Skills

Protocol digitization

USDM/ICH M11

CDISC SDTM/ADaM

AI/agentic orchestration

Regulated governance

Stakeholder management

LIMS/LIS integrations

CSV governance

Tools

EDC

REST/GraphQL APIs

ETL/ELT data pipelines

MDRs (Nurocor)

Job description

Regeneron is seeking a Global Development IT Associate Director, Product Lead to own a portfolio spanning protocol digitization, Digital Data Flow, and biospecimen lifecycle management. Based at our Warren, NJ location, this role requires four days onsite per week and leadership of Product Leads and Analysts.

You will translate enterprise priorities into capabilities, set domain vision, and partner with BSPs, SMEs, Corporate IT, and vendors to deliver compliant, auditable solutions across