Evidence Generation Operations & Compliance Director

Role: Lead enterprise governance and compliance for Medical-led evidence generation activities within Takeda's Global Medical organization. Responsibilities: establish and evolve standards for GxP and non-GxP evidence activities, partner with cross-functional teams (R&D QA, Medical, Legal, Regulatory, Digital) to ensure risk management, audit readiness, and quality oversight; leverage digital, data, automation, and AI tools to enhance transparency and proactive governance; support audit/inspection readiness and develop operational guidance and training materials. Requirements: degree in life sciences, pharmacy, medicine, or healthcare management; 10+ years in Medical Affairs, evidence generation/RWE, research operations, or quality/compliance, with experience overseeing governance frameworks, SOPs, and cross-functional collaborations in global or matrix environments; strong understanding of applicable laws, industry standards, and data privacy. HighValue: enterprise-level governance, GxP oversight, real-world evidence, digital and AI-enabled compliance, multi-country regulated environment, audit readiness, cross-functional stakeholder engagement, and evolving evidence generation methodologies. WorkSetup: based in Cambridge, MA, full-time, exempt.