Product Lead, Delivery & Operations

Build our future together: The Regeneron Global Development IT (GD IT) BDM/CGM & ES Lead serves as the P roduct Lead for the Data Lakehouse and Analytics platforms, partnering with Biostatistics Data Management (BDM), Clinical Genetics Medicine and Experimental Sciences (CGM/ES), compliance, and IT stakeholders to deliver compliant, scalable solutions. This role owns requirements analysis, roadmap alignment, backlog prioritization, and product delivery/execution across these platforms. Success in this role requires strong technical and domain expertise in data transfer and aggregation mechanisms from EDC , non-EDC (e.g., labs, biomarkers, and genetic data) and RWE sources as well as proficiency in R and Python for data management and statistical programming, and experience with AWS , Snowflake and Databricks . Experience is Human Sample Data management from Clinical Trial perspective is a huge plus. The role also demands strong Agile product delivery skills, cross-system integration experience, and adherence to global GxP and regulatory standards. When & where: Based at our Warren, NJ or Armonk, NY locations. 4 days on-site per week required. This role is not open to fully remote or hybrid work arrangements. Discover your role: Responsibilities include Lead GxP implementation of Data Lakehouse (AWS , Snowflake and Databricks ), Posit solutions and support exploratory non- GxP use cases Provide thought leadership and architectural inputs to shape a scalable future proof modern ecosystem Manage Human Sample Management as a unified product across sites, labs, EDC systems, and internal LIMS, centralizing data to track specimen location, status, and chain of custody while automating reconciliations Use AI and agents to enable digital transformation, from strategy to delivery, while remaining complaint and secure Manage product roadmaps and technical enablement Lead end-to-end requirements analysis, design, and configuration Manage scrum and kanban dashboards with team and ensure timely status updates to stakeholders Gather requirements, manage enhancements, coordinate system changes and user testing, and support release and change management. Operate within a product based Agile delivery model, owning roadmap execution, backlog prioritization, sprint planning, UAT, release management, and continuous improvement using Jira and ServiceNow. Drive stakeholder communication, change management, and delivery transparency, including status reporting, risk management, release communications, and cost/budget tracking. Work with team to create monthly/quarterly stakeholder communications, newsletters Document standards, processes, and best practices; provide training to technical and non ‑ technical teams. Participate in governance forums (steering committees, working groups, change reviews) to ensure alignment and cross ‑ functional collaboration Develop strong business relationships to clarify needs, anticipate requirements, and ensure solutions meet user expectations. Establish end to end data governance procedures with stakeholders This role requires: BS/ Degree with 10 + years relevant experienc e. MS or MBA with 6+ years preferred. Specifically in Life Sciences IT, Product Management, or Business/Systems Analysis with a strong focus on Clinical Data Manageme nt and Analytics Experience with data lakes/ lakehouses (Snowflake, Databricks, AWS) supporting Clinical, RW E , and Safety data Experience building data pipelines for transfer, cleaning, and aggregation from EDC (RAVE), eCOA , and non-EDC sources (lab, biomarker, genetic/omics data), including API and Regeneron Transfer Service (RTS) integrations Experience with Human Sample Management Hands-on proficiency in SAS, R, and Python, including R Shiny development/deployment, APIs, SAS Viya/Posit, and AI automation for clinical R&D Knowledge of CDISC standards (SDTM, ADaM ) and Pinnacle 21 Understanding of Data Management and Safety functions — signal detection, data quality, query management, lab data reconciliation Knowledge of CRO data transfer specs and data curation across studies/programs/therapeutic areas Knowledge of computer system validation, 21 CFR Part 11, GxP , CSV documentation (IQ/OQ/PQ), traceability, change control Und