Senior Manager, Product Management - Delivery & Operations Product Lead
Core
Drives end-to-end delivery, support, and optimization of a Global Development technology product focused on standards-led protocol digitization, biospecimen lifecycle management, and AI-enabled orchestration.
Role type
Senior Manager, Product Management - Delivery & Operations
Builds
Reusable digital assets powering Digital Data Flow (DDF) to improve study build speed, data quality, and regulatory compliance
Domain
Life Sciences / Clinical Development / Regulatory Technology
Deliverable
production ML models | product features
Required skills
Protocol digitization, biospecimen workflows, ICH M11/USDM standards, CDISC SDTM/ADaM, GxP compliance, AI-enabled product delivery, multi-system integrations (EDC, LIMS, IRT, CTMS), agile product management, vendor oversight, regulated change/validation processes
Preferred skills
AI/agentic trends, CDISC 360, executive communication, strategic planning, hands-on execution
Technologies
EDC, LIMS, IRT, CTMS, AI orchestration platforms
Responsibilities
Leading agile ceremonies and refining backlogs for protocol-to-data features, facilitating workshops with clinical and lab SMEs, reviewing architecture and validation plans for security and GxP compliance, supervising platform usage and AI guardrail metrics, managing vendor results and budgets, coordinating change and release processes
Seniority
Senior Manager, strategic planning with hands-on execution