Senior Manager, Product Management - Delivery & Operations Product Lead
Regeneron
10 days ago
On-site
Warren, NJ
IT
Delivery & Operations Product Lead (Senior Manager)
Own product vision, roadmap, and operations for a Global Development technology product focused on standards-led protocol digitization, biospecimen lifecycle management, and AI-enabled orchestration.
Responsibilities (typical day):
- Lead agile ceremonies, refine backlogs, and approve user stories for protocol-to-data and sample-workflow features
- Facilitate workshops with clinical, biometrics, and lab SMEs to gather requirements and prioritize improvements
- Review architecture and validation plans to ensure security, privacy, and GxP compliance for API and AI components
- Supervise platform usage, data-quality dashboards, and AI guardrail metrics to drive continuous improvement
- Manage vendor results, budgets, and risks; prepare executive-ready status updates
- Coordinate change, release, and incident processes to maintain audit-ready, high-performing operations
Qualifications/Required:
- BS/BA with 8–10 years (or MS with 6+ years) in Global Development IT, including protocol digitization, biospecimen workflows, and standards (ICH M11/USDM, CDISC SDTM/ADaM)
- Consistent track record delivering GxP-validated, AI-enabled products with integrations across EDC, LIMS, and analytics platforms
- Deep experience in agile product management, vendor oversight, and regulated change/validation processes
Preferred/Job Fit:
- Translate complex protocol/biospecimen/standards concepts into intuitive digital products
- Orchestrate multi-system integrations (EDC, LIMS, IRT, CTMS) with traceable data lineage
- Communicate effectively with executives and engineers; influence without authority
- Apply AI/agentic and CDISC 360 trends pragmatically in regulated settings; strong “get-it-done” mindset
Application:
- Apply now.
Own product vision, roadmap, and operations for a Global Development technology product focused on standards-led protocol digitization, biospecimen lifecycle management, and AI-enabled orchestration.
Responsibilities (typical day):
- Lead agile ceremonies, refine backlogs, and approve user stories for protocol-to-data and sample-workflow features
- Facilitate workshops with clinical, biometrics, and lab SMEs to gather requirements and prioritize improvements
- Review architecture and validation plans to ensure security, privacy, and GxP compliance for API and AI components
- Supervise platform usage, data-quality dashboards, and AI guardrail metrics to drive continuous improvement
- Manage vendor results, budgets, and risks; prepare executive-ready status updates
- Coordinate change, release, and incident processes to maintain audit-ready, high-performing operations
Qualifications/Required:
- BS/BA with 8–10 years (or MS with 6+ years) in Global Development IT, including protocol digitization, biospecimen workflows, and standards (ICH M11/USDM, CDISC SDTM/ADaM)
- Consistent track record delivering GxP-validated, AI-enabled products with integrations across EDC, LIMS, and analytics platforms
- Deep experience in agile product management, vendor oversight, and regulated change/validation processes
Preferred/Job Fit:
- Translate complex protocol/biospecimen/standards concepts into intuitive digital products
- Orchestrate multi-system integrations (EDC, LIMS, IRT, CTMS) with traceable data lineage
- Communicate effectively with executives and engineers; influence without authority
- Apply AI/agentic and CDISC 360 trends pragmatically in regulated settings; strong “get-it-done” mindset
Application:
- Apply now.