Assoc Dir Product Management
$157,200–$256,600 year
On-siteWarren, Michigan, United States or Armonk, New York, United States
Job Summary
Lead and coach a team of Product Leads and Analysts while owning end-to-end domain strategy for standards-led protocol digitization, Digital Data Flow, and human sample lifecycle management. Drive multi-product roadmap execution, chair governance forums, and manage stakeholder relationships across BSPs, Corporate IT, and vendors to translate enterprise priorities into capabilities. Intake, prioritize, and validate requirements while overseeing implementation, testing, and compliance with 21 CFR Part 11/Annex 11 and GxP. Establish digital protocol systems of record, manage vendor contracting, and direct AI/agentic orchestration with human-in-the-loop controls. Present innovative solutions in industry forums and lead end-to-end product launches or shutdowns across multiple teams.
Required Qualifications
- 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 (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
- 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
- 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
- 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
- of SDLC and ITSM/ITIL frameworks
- strong project, budget, and stakeholder management skills
- demonstrated success interacting with senior leadership
- 4 days onsite per week
Desired Qualifications
- 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 reports
- including leading or mentoring Product Leads/Product Managers
- instilling 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
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