Product Lead, Delivery & Operations
Overview
Application Category Skills
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:
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 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/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 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
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, SDLC/SSDLC frameworks
Preferred Qualifications
Strong data management and clinical analytics background with data governance experience
Proven experience in designing clinical data repositories, data lakes, data lake houses and optimizing it for multiple teams such as Data Management, RWD, Statistical Programming
Experience providing technical leadership on EDC and Non-EDC data integration into data lakes and data lake houses with other internal systems across business functions
Experience working in a highly matrixed organization and multi-disciplinary team
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
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.