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. Partnering with process owners, IT teams, and vendors, the role turns ICH M11/USDM and CDISC standards into reusable digital assets that power Digital Data Flow (DDF) and improve study build speed, data quality, and regulatory compliance.
You will own product vision, roadmap, and operations-balancing strategic planning with hands-on execution-while ensuring secure integrations, validated AI capabilities, and high levels of customer satisfaction.
In this role, a typical day might include the following:
- 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
- Coordinating change, release, and incident processes to maintain audit-ready, high-performing operations
This job might be for you if you:
- Translate complex protocol, biospecimen, and standards concepts into intuitive digital products
- Enjoy orchestrating multi-system integrations (EDC, LIMS, IRT, CTMS) and ensuring traceable data lineage
- Thrive in fast-paced, agile environments and can balance strategic goals with day-to-day execution
- Communicate clearly with executives and engineers alike, influencing without direct authority
- Stay current on AI/agentic and CDISC 360 trends and apply them pragmatically in regulated settings
- Possess a "get-it-done" attitude, solving issues quickly while keeping long-term value in focus
In order to be considered for this role, you must have:
- 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
Salary Range (annually)
$134,400.00 - $219,200.00
