Assoc Dir Product Management

Regeneron · Warren +1 more

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OtherFull-time$157k–$257kCompany career page

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Role summary

Associate Director of Product Management leading a portfolio of clinical development technology solutions including protocol digitization, digital data flow, and sample lifecycle management. The role combines strategic domain ownership with team leadership, requiring deep expertise in clinical trial standards, biospecimen workflows, and AI governance.

What they're looking for

Deep expertise in ICH M11/USDM, CDISC SDTM/ADaM standards, and protocol-to-data traceability
Proven experience managing technology selection, implementation, and operations across LIMS/LIS/EDC integrations
Practical knowledge of human sample workflows, chain of custody, and central/specialty lab models in clinical trials
Strong executive communication and senior stakeholder influence skills
Experience with AI/agentic systems, human-in-the-loop controls, and regulated AI governance (21 CFR Part 11/Annex 11)
Knowledge of pharmaceutical Global Development processes, SDLC, and ITIL frameworks
Team leadership experience: hiring, coaching, and developing Product Leads and Product Analysts

What you'll be doing

Lead and develop team of Product Leads and Product Analysts; set objectives and drive process-improvement culture
Own multi-product domain strategy, vision, and roadmap across protocol digitization, digital data flow, and sample management
Chair governance forums and steering committees; manage stakeholder alignment across business partners and vendors
Direct end-to-end product portfolio ownership including requirements, testing, compliance, and release management
Drive vendor selection, RFPs, contracting, and performance management; identify resourcing gaps across delivery teams

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