Senior Manager, Product Management - Delivery & Operations Product Lead

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. Typical day 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 Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Salary Range (annually) $134,400.00 - $219,200.00 #J-18808-Ljbffr