Head of Clinical, Regulatory, Quality & Therapeutic Area Unit (TAU) Data, Digital & Technology (DDT)

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Job Description

Head of Clinical, Regulatory, Quality & Therapeutic Area Unit (TAU) Data, Digital & Technology (DDT)

Location: Cambridge, MA (Hybrid)

Level: Vice President I

Job code:  DD_TGM_J_DDA_P

Reports to: Head, R&D and Global Medical Data, Digital & Technology (DD&T)

Role on Leadership Team: Member, R&D and Global Medical DD&T LT

Role Overview:

Takeda is recruiting an accomplished executive to serve as Vice President and Head of Clinical, Regulatory, Quality & Therapeutic Area Unit (TAU) Data, Digital & Technology (DDT). This strategic leadership position requires partnering closely with Clinical Development, Regulatory Affairs, R&D Quality and Therapeutic Area Units to advance business-facing technology initiatives. The role will spearhead the transformation of clinical and regulatory operations by leveraging data, digital technologies, and artificial intelligence—including generative and agentic systems—to enhance business processes. The ideal candidate will drive innovation, implement advanced platforms, foster new ways of working, and contribute significantly to the evolution of Takeda’s R&D and Global Medical DD&T.

Key Responsibilities:

• Strategic Partnership & Business Alignment: Serve as the primary strategic partner to Clinical Development, Regulatory Affairs, R&D Quality and Therapeutic Area (TAU) leaders, deeply understanding their scientific, operational, and regulatory needs. Shape and execute the end-to-end technology strategy for Clinical, Regulatory, R&D QA and TAUs, ensuring alignment with Takeda’s business priorities and R&D objectives.
• Platform & Product Leadership: Lead the design, development, and delivery of modern platforms supporting clinical trial execution, regulatory submissions, safety, evidence generation, and TA-specific workflows. Champion the adoption of AI and digital technologies across data management, trial design, study optimization, submission automation, knowledge management, and regulatory intelligence.
• Transformation & Modernization: Drive simplification and modernization of legacy systems and processes, fostering a culture of continuous improvement and operational excellence. Catalyze innovation by integrating emerging technologies (automation, AI/ML, GenAI, NLP) to enhance decision-making and efficiency.
• Stakeholder Engagement & Cross-Functional Collaboration: Build and nurture high-trust relationships with senior leaders across Clinical, Regulatory, TA Units, and Quality. Lead cross-functional collaboration to align technology strategies with evolving business and regulatory needs.
• Workforce & Talent Transformation: Build, lead, and mentor a high-performing, mission-driven technology organization that blends engineering, product, data science, and clinical/regulatory literacy. Establish a collaborative, inclusive culture that attracts and develops top talent, enabling the team to deliver on ambitious goals.
• Compliance, Governance & Quality: Ensure all platforms and solutions adhere to global regulatory standards and Takeda’s quality and risk management standards. Champion responsible and scalable adoption of AI, embedding compliance-by-design and ethical guidelines in all initiatives.
• Measurement & Accountability: Define and track key performance indicators (KPIs) to measure the impact of technology, digital, and AI initiatives. Ensure accountability for delivering measurable business value and continuous improvement.

Core Elements & Dimensions:

• Develop and drive a comprehensive DD&T strategy to address the unique challenges and opportunities in drug development
• Visionary leadership with the ability to set and execute enterprise-level strategies
• Innovation and Technology Integration: Champion end-to-end technology solutions to accelerate drug development, enhance data integration, and enable AI-driven insights
• Collaboration and Stakeholder Management: Build strong relationships and collaborate effectively with key stakeholders across R&D, external partners, and industry leaders
• Change Management: Acts as a change agent to promote innovative ways of working and foster co