Product Lead, Delivery & Operations
Warren, OH - USA
Job Summary
Build our future together:
The Regeneron Global Development IT (GD IT) BDM/CGM & ES Lead serves as theProductLeadfor 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 ownsrequirementsanalysis 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 EDCnon-EDC (e.g. labs biomarkers and genetic data)and RWE sourcesas well as proficiency in R and Python for data management and statistical programming and experience with AWSSnowflakeand Databricks.Experience is Human Sample Data management fromClinicalTrial perspective is a huge plus.The role also demands strong Agile product delivery skills cross-system integration experience and adherence to globalGxPand 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
LeadGxPimplementation ofData Lakehouse (AWSSnowflakeand Databricks) Positsolutions and support exploratorynon-GxPuse 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 toenable digital transformation from strategy to delivery while remaining complaint and secure
Manage product roadmapsandtechnicalenablement
Lead end-to-end requirements analysis design and configuration
Manage scrum andkanbandashboardswithteamand ensuretimelystatus updatesto stakeholders
Gather requirements manage enhancements coordinate system changes and user testing and support release and change management.
Operate within aproductbasedAgile delivery model owning roadmap execution backlog prioritization sprint planning UAT release management and continuous improvement using Jira and ServiceNow.
Drive stakeholder communication change management anddeliverytransparency including status reporting risk management release communications and cost/budget tracking.
Work with team to createmonthly/quarterly stakeholder communications newsletters
Document standards processes and best practices; provide training to technical andnontechnicalteams.
Participate in governance forums (steering committees working groups change reviews) to ensure alignment andcrossfunctionalcollaboration
Develop strong business relationships to clarify needsanticipaterequirements and ensure solutions meet user expectations.
Establish end to end data governance procedures with stakeholders
This role requires:
BS/ Degree with10 years relevantexperience.
MSor MBA with 6 years preferred.Specifically inLife Sciences IT Product Management or Business/Systems Analysis with a strong focus onClinicalData 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-onproficiencyin SAS R and Python including R Shiny development/deployment APIs SAS Viya/Posit and AI automation for clinical R&D
Knowledge of CDISC standards (SDTMADaM) 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 11GxP 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
Expertisewith 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
Proficiencyin 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
Provenexperience in designing clinical data repositories data lakes data lake houses andoptimizingit for multiple teamssuch as Data Management RWD Statistical Programming
Experience providing technical leadershipon EDC and Non-EDC data integration into data lakes and data lake houses with other internal systemsacross business functions
Experience working in a highly matrixed organization and multi-disciplinary team
Experience managingstakeholderexpectations and ability to prioritize conflicts
Experiencewith JIRA for backlog and delivery management; exposure to ServiceNowJIRA integrations
Certification or equivalentexperiencein product management
Good understanding ofAgentic AI andGenerative 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 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 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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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.
Salary Range (annually)
$134400.00 - $219200.00Required Experience:
Senior IC
About Company
Discover how Regeneron (NASDAQ: REGN) harmonizes biology and technology to create life-changing medicines. Join our team and explore clinical trials.