Evidence Generation Operations & Compliance Director

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Job Description

OBJECTIVES / PURPOSE

• Provides enterprise-level governance, operational standards and compliance leadership for Medical-led evidence generation activities within Global Medical.
• Serves as the primary Medical Governance Office lead for evidence generation operations, ensuring consistent governance, oversight, quality, risk management and inspection readiness across Medical-led research activities while partnering with R&D Quality Assurance as the enterprise quality authority for applicable GxP research activities.
• Establishes clear governance expectations aligned with Takeda standards, applicable laws and regulations, local requirements, industry codes, enterprise quality frameworks and audit expectations, while continuously evolving governance approaches to leverage digital technologies, data transparency, automation and AI-enabled compliance capabilities.
• Ensures applicable evidence generation activities follow clear intake, risk assessment, documentation, oversight, escalation, close-out and audit-readiness expectations.
• Partners with Global Medical Evidence Generation, R&D Quality Assurance, Medical teams, Ethics & Compliance, Legal, Regulatory, Pharmacovigilance, Digital/DD&T, and other experts as needed to support patient-centric, scientifically robust and compliant execution.

ACCOUNTABILITIES

• Serve as the operational governance counterpart to R&D Quality Assurance for Medical-led evidence generation activities, ensuring appropriate implementation of enterprise quality expectations, GxP oversight principles, inspection readiness practices and risk-management approaches while aligning Medical operational requirements with enterprise quality frameworks.
• Establish and evolve enterprise governance standards for Medical-led evidence generation activities, ensuring consistent quality, transparency, oversight and compliance across both GxP and non-GxP evidence generation modalities, with direct accountability for governance frameworks supporting real-world evidence activities not subject to enterprise GxP quality governance.
• Define governance pathways, decision rights, roles and responsibilities, escalation criteria and minimum documentation requirements for evidence generation activities within the Medical Governance Office (MGO) remit.
• Provide operational governance oversight and maintain governance visibility through inventories, status tracking, dashboards, risk indicators and performance metrics. Leverage data, automation and AI-enabled monitoring capabilities to enhance transparency, identify emerging risks and support proactive governance decision-making.
• Partner with Global Medical Evidence Generation, R&D Quality Assurance, Ethics & Compliance, Legal, Regulatory, Pharmacovigilance and Digital/DD&T to align governance expectations with applicable laws and regulations, quality frameworks, Takeda SOPs, data privacy, data integrity, AI governance requirements and industry-code expectations.
• Support audit and inspection readiness, including documentation standards, quality checks, issue escalation, remediation/CAPA follow-up and closure, while coordinating closely with R&D Quality Assurance for activities subject to enterprise quality oversight and inspection frameworks.
• Define minimum governance expectations for external partners and vendor-supported activities, including appropriate oversight, documentation, conflict-of-interest and issue-escalation requirements.
• Develop practical operating materials, including intake questions, risk-assessment tools, checklists, governance playbooks, SOP/standard inputs and training materials.
• Build capability and drive continuous improvement through guidance, onboarding, governance forums and recommendations to the Medical leadership.
• Partner closely with Global Evidence Generation Strategy & Operations and Clinical Science and Study Operations Group to identify opportunities to modernize evidence generation operations through emerging technologies, intelligent workflow design, advanced analytics and responsible AI solutions that improve compliance, efficiency, documentation quality, oversight effectiveness and user experience.

DIMENSIONS AND ASPECTS

• Provides enterprise governance standards and