Assoc Dir Product Management
Regeneron
August 12, 2026
Remote friendly (Warren, NJ)
United States
Marketing
Responsibilities:
- Lead, coach, and develop Product Leads and Product Analysts across protocol digitization, biospecimen/sample management, and AI/agentic orchestration.
- Set objectives, build domain capabilities, and drive process improvement.
- Own domain strategy, vision, and roadmap for USDM/ICH M11 protocol digitization, Digital Data Flow (DDF), and human sample lifecycle.
- Build and manage senior stakeholder relationships (BSPs, Business Process Owners, SMEs, Corporate IT, vendors).
- Chair domain steering/gov forums; drive alignment, consistency, and reuse.
- Own end-to-end domain product portfolio: requirements, testing/UAT, risk-based CSV, and ITIL-aligned release/change/incident processes for audit readiness and compliance.
- Intake and validate domain requirements; manage scope, dependencies, and trade-offs.
- Define human-in-the-loop, multi-agent orchestration and regulated-AI governance aligned to 21 CFR Part 11/Annex 11 and GxP.
- Manage build-vs-buy, RFPs, contracting, vendor performance, and delivery resourcing.
- Ensure digital protocol and Schedule of Activities as system of record with traceable lineage from protocol intent to SDTM/ADaM.
- Direct biospecimen/sample standards, metadata, and integration ecosystem (MDR, EDC, IRT, LIMS/LIS, CTMS, analytics).
This Role Requires:
- Strong command of ICH M11/USDM and CDISC SDTM/ADaM; controlled terminology and standards governance; experience with USDM-aligned tools (e.g., Nurocor) or equivalent MDRs.
- Communication skills to influence senior leaders.
- Clinical human sample workflow knowledge (kit management, barcoding, custody, reconciliation) and lab operating models/integrations (SAP/EDC).
- Experience with technology selection/implementation/operations; LIMS/LIS integrations; vendor governance.
- Experience applying AI/multi-agent systems with human-in-the-loop controls; REST/GraphQL and ETL/ELT on cloud platforms.
- Knowledge of Global Development capabilities/processes; SDLC and ITSM/ITIL; strong project/budget/stakeholder management.
- Preferred: SQL/Python or R for prototyping/validation and regulated MLOps; exposure to TransCelerate DDF and CDISC 360.
- Experience with risk-based CSV and regulated-AI governance aligned to 21 CFR Part 11/Annex 11, GxP, HIPAA/GDPR, RBAC.
- Experience hiring/coaching direct reports; leading end-to-end product launches/shutdowns; strategic/tactical leadership amid ambiguity.
Application:
- Apply now.
- Lead, coach, and develop Product Leads and Product Analysts across protocol digitization, biospecimen/sample management, and AI/agentic orchestration.
- Set objectives, build domain capabilities, and drive process improvement.
- Own domain strategy, vision, and roadmap for USDM/ICH M11 protocol digitization, Digital Data Flow (DDF), and human sample lifecycle.
- Build and manage senior stakeholder relationships (BSPs, Business Process Owners, SMEs, Corporate IT, vendors).
- Chair domain steering/gov forums; drive alignment, consistency, and reuse.
- Own end-to-end domain product portfolio: requirements, testing/UAT, risk-based CSV, and ITIL-aligned release/change/incident processes for audit readiness and compliance.
- Intake and validate domain requirements; manage scope, dependencies, and trade-offs.
- Define human-in-the-loop, multi-agent orchestration and regulated-AI governance aligned to 21 CFR Part 11/Annex 11 and GxP.
- Manage build-vs-buy, RFPs, contracting, vendor performance, and delivery resourcing.
- Ensure digital protocol and Schedule of Activities as system of record with traceable lineage from protocol intent to SDTM/ADaM.
- Direct biospecimen/sample standards, metadata, and integration ecosystem (MDR, EDC, IRT, LIMS/LIS, CTMS, analytics).
This Role Requires:
- Strong command of ICH M11/USDM and CDISC SDTM/ADaM; controlled terminology and standards governance; experience with USDM-aligned tools (e.g., Nurocor) or equivalent MDRs.
- Communication skills to influence senior leaders.
- Clinical human sample workflow knowledge (kit management, barcoding, custody, reconciliation) and lab operating models/integrations (SAP/EDC).
- Experience with technology selection/implementation/operations; LIMS/LIS integrations; vendor governance.
- Experience applying AI/multi-agent systems with human-in-the-loop controls; REST/GraphQL and ETL/ELT on cloud platforms.
- Knowledge of Global Development capabilities/processes; SDLC and ITSM/ITIL; strong project/budget/stakeholder management.
- Preferred: SQL/Python or R for prototyping/validation and regulated MLOps; exposure to TransCelerate DDF and CDISC 360.
- Experience with risk-based CSV and regulated-AI governance aligned to 21 CFR Part 11/Annex 11, GxP, HIPAA/GDPR, RBAC.
- Experience hiring/coaching direct reports; leading end-to-end product launches/shutdowns; strategic/tactical leadership amid ambiguity.
Application:
- Apply now.