Assoc Dir Product Management

Overview

Global Development IT (GD IT) Associate Director, Product Lead is a leader within the GD IT Delivery & Operations organization. Responsible 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. 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, 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.

• Assume domain-level product ownership, including end-to-end implementation, governance, compliance, and support for all products within the domain.
• 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; prioritize and trade off 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 to drive alignment, consistency, and reuse.
• Take end-to-end ownership of the domain product portfolio—including 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 with BSPs; manage 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) aligned to 21 CFR Part 11/Annex 11 and GxP.
• Drive build-vs-buy assessments, RFPs, software/services contracting, 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 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., Trans Celerate DDF, CDISC 360).
• Collaborate with GD IT, Corporate IT, and other functions on enterprise systems, standards, and governance; serve as senior point of contact and escalation for the domain across Global Development.

• 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 with human-in-the-loop controls, plus technical fluency in REST/GraphQL APIs, events, and data pipelines (ETL/ELT) on modern cloud platforms.
• Knowledge of pharmaceutical Global Development business capabilities, processes, and systems; familiarity with SDLC and ITSM/ITIL frameworks; strong project, budget, and stakeholder management skills.
• Preferred: SQL/Python or R for prototyping/validation and MLOps in regulated environments; exposure to Trans Celerate DDF and CDISC 360 initiatives.
• Experience applying risk-based CSV and regulated-AI governance aligned to 21 CFR Part 11/Annex 11, GxP, and data protection (HIPAA/GDPR, RBAC).
• Experience hiring, supervising, mentoring, and coaching a team of direct reports, instilling a process-improvement culture and championing agile ways of…