Product Lead, Delivery & Operations

About the role

The Regeneron Global Development IT (GD IT) BDM/CGM & ES Lead serves as the Product 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 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, proficiency in R and Python for data management and statistical programming, and experience with AWS, Snowflake and Databricks. Experience managing Human Sample Data from a Clinical Trial perspective is a 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. Four days on-site per week required. This role is not open to fully remote or hybrid work arrangements.

Responsibilities

• 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 compliant 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 and newsletters
• Document standards, processes, and best practices; provide training to technical and nontechnical 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

Requirements

• BS/BA degree with 10+ years of relevant experience; MS or MBA with 6+ years preferred
• Experience in Life Sciences IT, Product Management, or Business/Systems Analysis with a strong focus on Clinical Data Management and Analytics
• Experience with data lakes/lakehouses (Snowflake, Databricks, AWS) supporting Clinical, RWE, 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 specifications 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
• Understanding of blinded/unblinded datasets, interim analysis, and DB Lock sensitivities
• Experience with ML and visual analytics (feature engineering, training, evaluation) via R, Python, SAS, Posit
• Expertise with Generative and Agentic AI (RAG, Agents, MCP, Claude, GPT)
• Experience with AWS, DevOps, CI/CD workflows
• Experience deploying analytical workloads/Shiny apps to cloud, including production troubleshooting
• Experience with CRAN, Git/Bitbucket, version control best practices
• Proficiency in Agile Product Lead delivery: backlogs, user stories, sprint planning, UAT, roadmap alignment
• Strong analytical and communication skills translating technical/regulatory requirements for stakeholders
• Knowledge of pharma R&D/clinical development processes and SDLC/SSDLC frameworks

Preferred Qualifications

• Strong data management and clinical analytics background with data governance experience
• Proven experience designing clinical data repositories, data lakes, and data lakehouses and optimizing them for Data Management, RWD, and Statistical Programming teams
• Experience providing technical leadership on EDC and Non-EDC data integration into data lakes and data lakehouses with other internal systems across business functions
• Experience working in a highly matrixed organization and multi-disciplinary teams
• Experience managing stakeholder expectations and ability to prioritize conflicts
• Experience with JIRA for backlog and delivery management; exposure to ServiceNow/JIRA integrations
• Certification or equivalent experience in product management
• Good understanding of Agentic AI and Generative AI tools and capabilities
• Background documenting best practices for configuration, data quality, release management, and governance
• Veeva, Salesforce, or Product Management certifications

Pay

Salary range (annually): $134,400.00 – $219,200.00