Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

The Global Development IT (GD IT) Associate Director, Product Lead is responsible for the strategy, delivery, and continuous improvement of technology products for standards-led protocol digitization, Digital Data Flow (DDF), and human sample lifecycle management. This role may manage a team, set domain vision and roadmap, and partner with stakeholders to translate enterprise priorities into capabilities.

Responsibilities

• Lead, coach, and develop a team of Product Leads and Product Analysts.
• 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, Digital Data Flow, and the human sample lifecycle.
• Build and manage senior stakeholder relationships.
• Chair domain steering committees and governance forums.
• Take end-to-end ownership of the domain product portfolio, including implementation, performance, and continuous improvement.
• Intake, assess, prioritize, and validate domain requirements.
• Set direction for human-in-the-loop, multi-agent orchestration and regulated-AI governance.
• Drive build-vs-buy assessments, RFPs, software/services contracting, and vendor performance management.
• Direct establishment of the digital protocol and structured Schedule of Activities as system of record.
• Provide direction over biospecimen/sample standards, metadata, and the integration ecosystem.
• Provide subject matter expertise to manage business expectations, timelines, and domain budget.
• Collaborate on enterprise systems, standards, and governance.
• Act tactically and think strategically, switching leadership styles to influence, guide, and coach.
• Manage multiple priorities and a portfolio of products amid ambiguity and changing priorities.
• Lead an end-to-end product launch or shutdown across multiple teams.

Requirements

• Strong command of ICH M11/USDM, CDISC SDTM/ADaM, controlled terminology, and standards governance.
• Demonstrated delivery of structured protocol authoring and protocol-to-data automations with traceable lineage into SDTM/ADaM.
• Experience with USDM-aligned tools or equivalent MDRs.
• Excellent communication skills and the ability to influence senior leaders and stakeholders.
• Practical understanding of human sample workflows in clinical trials.
• Experience managing technology capability identification, selection, implementation, and operations.
• Experience applying AI and multi-agent/agentic systems with human-in-the-loop controls.
• Technical fluency in integration patterns and data pipelines on modern cloud platforms.
• Knowledge of pharmaceutical Global Development business capabilities, processes, and systems.
• Knowledge of SDLC and ITSM/ITIL frameworks.
• Strong project, budget, and stakeholder management skills.
• Demonstrated success interacting with senior leadership.
• Experience applying risk-based CSV and regulated-AI governance aligned to 21 CFR Part 11/Annex 11, GxP, and data protection.
• Experience hiring, supervising, motivating, and coaching a team of direct reports.
• Instilling a process-improvement culture and championing agile ways of working.

Skills

• ICH M11/USDM
• CDISC SDTM/ADaM
• Controlled terminology
• Standards governance
• Structured protocol authoring
• Protocol-to-data automations
• USDM-aligned tools
• MDRs
• Communication
• Influencing senior leaders
• Stakeholder management
• Human sample workflows
• Clinical trials
• Central/specialty lab operating models
• Biospecimen/lab and SAP/EDC integrations
• Technology capability identification
• Technology selection
• Technology implementation
• Technology operations
• LIMS/LIS integrations
• EDC integrations
• IRT integrations
• CTMS integrations
• Analytics integrations
• Vendor governance
• AI
• Multi-agent/agentic systems
• Human-in-the-loop controls
• Integration patterns
• REST APIs
• GraphQL APIs
• Events
• Data pipelines
• ETL
• ELT
• Modern cloud platforms
• Pharmaceutical Global Development business capabilities
• Pharmaceutical Global Development processes
• Pharmaceutical Global Development systems
• SDLC
• ITSM/ITIL frameworks
• Project management
• Budget management
• Risk-based CSV
• Regulated-AI governance
• Audit trails
• Prompt/version control
• 21 CFR Part 11/Annex 11
• GxP
• Data protection
• HIPAA/GDPR
• RBAC
• Hiring
• Supervising
• Motivating
• Coaching
• Process improvement
• Agile ways of working
• Product launch
• Product shutdown
• SQL
• Python
• R
• MLOps
• Model/package registries
• Approval workflows
• TransCelerate DDF
• CDISC 360

Location

• Warren, NJ

Work Type

• Onsite (4 days per week)

Experience Level

• Associate Director

Salary/Compensations

• $157,200.00 - $256,600.00

Benefits

• 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
• Family support benefits

About the Company

• We are committed to building a workplace with an inclusive culture.
• Regeneron offers a competitive and comprehensive total rewards package.
• We believe we do our best work when we are together.
• 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.

Equal Opportunity

• 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.