Product Lead, Delivery & Operations

Build our future together:

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 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:

• 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 Service Now.

• 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 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

This role requires:

• BS/ Degree with 10+ years relevant experience.

• 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 Management and Analytics

• Experience with data lakes/lake houses (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 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…