Assoc Dir Product Management
Regeneron
September 02, 2026
Remote friendly (Warren, NJ)
United States
Marketing
Responsibilities:
- Lead, coach, and develop a team of Product Leads and Product Analysts across protocol digitization, biospecimen/sample management, and AI/agentic orchestration.
- Set domain objectives, build capabilities, and instill a process-improvement culture.
- Own multi-product domain strategy, vision, and roadmap for USDM/ICH M11 protocol digitization, DDF, and human sample lifecycle; prioritize and make trade-offs.
- Partner with senior stakeholders, BSPs, Business Process Owners, SMEs, Corporate IT, and vendors; chair steering committees and governance forums.
- Provide end-to-end domain product ownership: requirements intake, testing/UAT, risk-based CSV, and ITIL-aligned release/change/incident processes to ensure performance, audit readiness, and compliance.
- Define regulated-AI governance and direction for human-in-the-loop, multi-agent orchestration (21 CFR Part 11/Annex 11, GxP).
- Lead build-vs-buy, RFPs, contracting, vendor performance, and internal/vendor delivery.
- Oversee digital protocol/Schedule of Activities as system of record; ensure traceable lineage to CRF/EDC, SDTM, ADaM, and analysis outputs.
- Guide biospecimen/sample standards, metadata, and integrations (MDR, EDC, IRT, LIMS/LIS, CTMS, analytics).
This Role Requires:
- Command of ICH M11/USDM and CDISC SDTM/ADaM; controlled terminology/standards governance; experience with structured protocol authoring and protocol-to-data automations.
- Knowledge of clinical trial human sample workflows and lab operating models; experience with SAP/EDC and integrations.
- Experience delivering and governing LIMS/LIS/EDC/IRT/CTMS/analytics integrations and technology operations across global teams.
- AI/multi-agent systems with human-in-the-loop controls; cloud integration/data pipeline fluency.
- SDLC/ITIL/ITSM expertise; strong project/budget/stakeholder management.
- Preferred: SQL/Python or R for prototyping/validation; MLOps in regulated environments; exposure to TransCelerate DDF and CDISC 360.
- Experience with risk-based CSV and regulated-AI governance (21 CFR Part 11/Annex 11, GxP; HIPAA/GDPR, RBAC).
- Experience leading/hiring/coaching teams and launching/shutting down end-to-end products.
Where/When:
- Warren, NJ; 4 days onsite per week required.
Application:
- Apply now.
- Lead, coach, and develop a team of Product Leads and Product Analysts across protocol digitization, biospecimen/sample management, and AI/agentic orchestration.
- Set domain objectives, build capabilities, and instill a process-improvement culture.
- Own multi-product domain strategy, vision, and roadmap for USDM/ICH M11 protocol digitization, DDF, and human sample lifecycle; prioritize and make trade-offs.
- Partner with senior stakeholders, BSPs, Business Process Owners, SMEs, Corporate IT, and vendors; chair steering committees and governance forums.
- Provide end-to-end domain product ownership: requirements intake, testing/UAT, risk-based CSV, and ITIL-aligned release/change/incident processes to ensure performance, audit readiness, and compliance.
- Define regulated-AI governance and direction for human-in-the-loop, multi-agent orchestration (21 CFR Part 11/Annex 11, GxP).
- Lead build-vs-buy, RFPs, contracting, vendor performance, and internal/vendor delivery.
- Oversee digital protocol/Schedule of Activities as system of record; ensure traceable lineage to CRF/EDC, SDTM, ADaM, and analysis outputs.
- Guide biospecimen/sample standards, metadata, and integrations (MDR, EDC, IRT, LIMS/LIS, CTMS, analytics).
This Role Requires:
- Command of ICH M11/USDM and CDISC SDTM/ADaM; controlled terminology/standards governance; experience with structured protocol authoring and protocol-to-data automations.
- Knowledge of clinical trial human sample workflows and lab operating models; experience with SAP/EDC and integrations.
- Experience delivering and governing LIMS/LIS/EDC/IRT/CTMS/analytics integrations and technology operations across global teams.
- AI/multi-agent systems with human-in-the-loop controls; cloud integration/data pipeline fluency.
- SDLC/ITIL/ITSM expertise; strong project/budget/stakeholder management.
- Preferred: SQL/Python or R for prototyping/validation; MLOps in regulated environments; exposure to TransCelerate DDF and CDISC 360.
- Experience with risk-based CSV and regulated-AI governance (21 CFR Part 11/Annex 11, GxP; HIPAA/GDPR, RBAC).
- Experience leading/hiring/coaching teams and launching/shutting down end-to-end products.
Where/When:
- Warren, NJ; 4 days onsite per week required.
Application:
- Apply now.