Assoc Dir Product Management

The Global Development IT (GD IT) Associate Director Product Lead is a leader within the GD IT Delivery & Operations organization accountable for the strategy delivery and continuous improvement of a portfolio of technology products spanning standards-led protocol digitization (USDM/ICH M11) Digital Data Flow (DDF) and human sample lifecycle management. This role may provide line management to a team of Product Leads and Product Analysts set the domain vision and roadmap and partner with senior business stakeholders Business Solution Partners (BSPs) Business Process Owners SMEs Corporate IT and vendor partners to translate enterprise priorities into capabilities that enable standard-led protocol digitization biospecimen and sample management and AI/agentic orchestration across Global Development. The Associate Director assumes domain-level product ownership including end-to-end implementation governance compliance and support for all products that fall within the domain.

Where: Based at our Warren NJ location

When: 4 days onsite per week required

Discover your role:

• Lead coach and develop a team of Product Leads and Product Analysts across protocol digitization biospecimen/sample management and AI/agentic orchestration
• Set objectives build domain capabilities and instill a process-improvement culture.

• Own the multi-product domain strategy vision and roadmap for standards-led protocol digitization (USDM/ICH M11) Digital Data Flow (DDF) and the human sample lifecycle prioritizing and making trade-offs across product lines.
• Build and manage senior stakeholder relationships across BSPs Business Process Owners SMEs Corporate IT and vendors
• Chair domain steering committees and governance forums and drive alignment consistency and reuse across Product Leads
• Take end-to-end ownership of the domain product portfolioimplementation performance and continuous improvementoverseeing requirements testing/UAT risk-based CSV and ITIL-aligned release change and incident processes to meet business expectations audit readiness and compliance
• Intake assess prioritize and validate domain requirements in partnership with BSPs managing scope dependencies and trade-offs to align technology roadmaps with product priorities.
• Set direction for human-in-the-loop multi-agent orchestration and regulated-AI governance (prompt/version control evaluation audit trails risk-based CSV) aligned to 21 CFR Part 11/Annex 11 and GxP.
• Drive build-vs-buy assessments RFPs software/services contracting and vendor performance management; identify resourcing needs and oversee internal vendor and managed-service delivery.
• Direct establishment of the digital protocol and structured Schedule of Activities as system of record ensuring traceable continuity from protocol intent through CRF/EDC to SDTM ADaM and analysis outputs.
• Provide direction over biospecimen/sample standards metadata and the integration ecosystem (MDR EDC IRT LIMS/LIS CTMS analytics) ensuring lineage and reconciliation aligned to central and specialty lab operating models.
• Provide subject matter expertise to manage business expectations timelines and domain budget; present innovative solutions and represent the organization in industry and standards forums (e.g. TransCelerate DDF CDISC 360).
• Collaborate with GD IT Corporate IT and other functions on enterprise systems standards and governance serving as senior point of contact and escalation for the domain across Global Development.

This role requires:

• Strong command of ICH M11/USDM CDISC SDTM/ADaM controlled terminology and standards governance with demonstrated delivery of structured protocol authoring and protocol-to-data automations with traceable lineage into SDTM/ADaM; experience with USDM-aligned tools (e.g. Nurocor) or equivalent MDRs
• Excellent communication skills and the ability to influence senior leaders and stakeholders including executive-ready communications
• Practical understanding of human sample workflows in clinical trials (kit management barcoding collection/processing shipping/receipt chain of custody reconciliation) central/specialty lab operating models and biospecimen/lab and SAP/EDC integrations
• Experience managing technology capability identification selection implementation and operations including LIMS/LIS integrations with EDC IRT CTMS and analytics and vendor governance across global teams
• Experience applying AI and multi-agent/agentic systems (tool/function calling RAG prompt management evaluation monitoring) with human-in-the-loop controls plus technical fluency in integration patterns (REST/GraphQL APIs events) and data pipelines (ETL/ELT) on modern cloud platforms
• Knowledge of pharmaceutical Global Development business capabilities processes and systems and of SDLC and ITSM/ITIL frameworks with strong project budget and stakeholder management skills and demonstrated success interacting with senior leadership
• Preferred: familiarity with SQL/Python or R for prototyping/validation and MLOps in regulated environments (model/package registries approval workflows); exposure to TransCelerate DDF and CDISC 360 initiatives
• Experience applying risk-based CSV and regulated-AI governance (audit trails evaluation prompt/version control) aligned to 21 CFR Part 11/Annex 11 GxP and data protection (HIPAA/GDPR RBAC)
• Experience hiring supervising motivating and coaching a team of direct reportsincluding leading or mentoring Product Leads/Product Managersinstilling a process-improvement culture and championing agile ways of working across cross-functional partners
• Experience leading an end-to-end product launch or shutdown across multiple teams.

• Ability to act tactically and think strategically switching leadership styles to influence guide and coach and to manage multiple priorities and a portfolio of products amid ambiguity and changing priorities

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)