Domain Product Lead - Protocol Digitization & AI Orchestration

Initial Therapeutics, Inc.; 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 drive strategy, delivery, and continuous improvement across protocol digitization, Digital Data Flow, and biospecimen lifecycle management. You will lead a team of Product Leads and Analysts, align domain roadmaps with senior stakeholders, and ensure compliant end-to-end delivery.

Based at the Warren, NJ location with four days onsite per week, you will influence cross-functional partners, manage budgets, and

Qualifications

• Strong command of ICH M11/USDM, CDISC SDTM/ADaM, and standards governance.
• Delivery of protocol digitization and data automation with traceable lineage.
• Experience with AI and multi-agent governance in regulated environments.

Responsibilities

• Lead and develop a team of Product Leads and Product Analysts.
• Own the domain strategy, vision, and roadmap for protocol digitization and DDF.
• Manage senior stakeholder relationships across BSPs, SMEs, and Corporate IT.
• Oversee end-to-end implementation, governance, and compliance for domain products.
• Drive vendor management, build-buy decisions, and RFPs for the portfolio.

Skills

ICH M11 / USDM knowledge

CDISC SDTM/ADaM knowledge

AI / multi-agent governance

Stakeholder management

Leadership / mentoring

SDLC / ITIL frameworks

Tools

LIMS/LIS integrations

EDC/CTMS integrations

REST/GraphQL APIs

Job description

Regeneron is seeking a Global Development IT Associate Director, Product Lead to drive strategy, delivery, and continuous improvement across protocol digitization, Digital Data Flow, and biospecimen lifecycle management. You will lead a team of Product Leads and Analysts, align domain roadmaps with senior stakeholders, and ensure compliant end-to-end delivery.

Based at the Warren, NJ location with four days onsite per week, you will influence cross-functional partners, manage budgets, and