Senior Manager, Product Management - Delivery & Operations Product Lead

About the role

The Delivery & Operations Product Lead (Senior Manager) 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.

Responsibilities

• Leading agile ceremonies, refining backlogs, and approving user stories for protocol-to-data and sample-workflow features
• Facilitating workshops with clinical, biometrics, and lab SMEs to gather requirements and prioritize improvements
• Reviewing architecture and validation plans to ensure security, privacy, and GxP compliance for API and AI components
• Supervising platform usage, data-quality dashboards, and AI guardrail metrics to drive continuous improvement
• Managing vendor results, budgets, and risks while preparing executive-ready status updates
• Coinciding change, release, and incident processes to maintain audit-ready, high-performing operations

Requirements

• 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

Qualifications

• 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

Skills

• Translate complex protocol, biospecimen, and standards concepts into intuitive digital products
• Orchestrates multi-system integrations (EDC, LIMS, IRT, CTMS) and ensures traceable data lineage
• Thrives in fast-paced, agile environments and balances strategic goals with day-to-day execution
• Communicates clearly with executives and engineers alike, influencing without direct authority
• Stays current on AI/agentic and CDISC 360 trends and applies them pragmatically in regulated settings
• Possesses a “get-it-done” attitude, solving issues quickly while keeping long-term value in focus

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

Pay

$134,400.00 - $219,200.00 annually

Schedule

Full-time