Global Development Product Strategy Lead

BioSpace; New Jersey; On-site; USD 157,000 - 257,000; Full time

Job summary

Regeneron in Warren, NJ is seeking an Associate Director, Product Lead within Global Development IT. You will own a portfolio spanning protocol digitization, Digital Data Flow, and human sample lifecycle management, driving strategy, delivery, and governance.

The role may lead a team of Product Leads and Analysts, partner with BSPs, SMEs, and Corporate IT, and ensure audit readiness, compliant release processes, and ongoing improvement. Four days onsite per week are required.

Qualifications

• Experience delivering end-to-end product programs in regulated environments.
• Ability to partner with senior leadership and stakeholders.
• Strong knowledge of SDLC and ITIL/ITSM.
• Experience with risk-based CSV and governance.

Responsibilities

• Own domain strategy, vision, and roadmap for protocol digitization and data flow.
• Lead and coach a team of Product Leads and Analysts.
• Manage end-to-end product portfolio, including requirements, testing, CSV, and release.
• Foster senior stakeholder relationships across BSPs and IT partners.
• Drive build-vs-buy decisions and vendor performance management.

Skills

ICH M11/USDM

CDISC SDTM/ADaM

AI governance

GxP compliance

CSV governance

Vendor governance

REST/GraphQL APIs

RAG

multi-agent systems

Job description

Regeneron in Warren, NJ is seeking an Associate Director, Product Lead within Global Development IT. You will own a portfolio spanning protocol digitization, Digital Data Flow, and human sample lifecycle management, driving strategy, delivery, and governance.

The role may lead a team of Product Leads and Analysts, partner with BSPs, SMEs, and Corporate IT, and ensure audit readiness, compliant release processes, and ongoing improvement. Four days onsite per week are required.