Assoc Dir Product Management

Role: Associate Director, Product Lead within GD IT Delivery & Operations, responsible for strategy, delivery, and improvement of technology products supporting clinical development processes, including protocol digitization (USDM/ICH M11), Digital Data Flow, and human sample lifecycle management. Responsibilities: lead and develop cross-functional teams, define domain vision and roadmaps, manage stakeholder relationships, oversee end-to-end product implementation, governance, compliance, and continuous enhancement; drive vendor selection, build ecosystems, and ensure regulatory adherence (21 CFR Part 11, GxP). Requirements: extensive experience in life sciences IT, strong knowledge of ICH M11/USDM, CDISC standards, and clinical workflows; expertise in AI/agentic systems, cloud data pipelines, and regulated AI governance; proven leadership in product management, stakeholder influence, and cross-functional collaboration; familiarity with SDLC, ITSM/ITIL, risk-based CSV, and vendor management. Preferred: experience with SQL/Python/R, MLOps, TransCelerate DDF, and CDISC 360 initiatives; background in biospecimen/sample management, clinical data integration, and regulated environments. HighValue: clinical development, protocol digitization, biospecimen lifecycle, AI/agentic orchestration, regulated AI governance, GxP, cross-functional leadership, global IT standards. WorkSetup: hybrid in Warren, NJ, with 4 days onsite/week.