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: DDTGMJDDAP

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 intelligenceincluding generative and agentic systemsto enhance business processes. The ideal candidate will drive innovation implement advanced platforms foster new ways of working and contribute significantly to the evolution of Takedas 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 Takedas 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 Takedas 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 collaboration with external and internal partners
• Resource Management: Manage budgets and resources efficiently to achieve technical milestones
• Decision-making & Autonomy: High-impact complex decision-making authority and accountability for global outcomes
• Complexity: Managing global teams diverse portfolios and navigating a dynamic external environment

Qualifications:

• Minimum 15 years of leadership experience in pharmaceutical/biotech R&D with a track record of digital transformation and executive-level responsibility
• Proven leadership in clinical development regulatory technology or adjacent R&D technology domains.
• Demonstrated success leading large-scale digital data or AI transformations in complex global environments.
• Strong understanding of GxP regulatory pathways worldwide submission processes and clinical trial operationspaired with an innovation-first mindset.
• Ability to influence senior scientific and operational leaders; excellent storytelling and change-leadership skills.
• Experience setting and governing DD&T strategy across multiple therapeutic areas balancing TA-specific requirements with enterprise platforms standards and operating models
• Executive presence strategic thinking and a track record of delivering meaningful business outcomes.
• Advanced degree in a relevant field (life sciences computer science engineering regulatory science or MBA preferred).

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical dental vision insurance a 401(k) plan and company match short-term and long-term disability coverage basic life insurance a tuition reimbursement program paid volunteer time off company holidays and well-being benefits among others. U.S. based employees are also eligible to receive per calendar year up to 80 hours of sick time and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race color religion sex sexual orientation gender identity gender expression parental status national origin age disability citizenship status genetic information or characteristics marital status status as a Vietnam era veteran special disabled veteran or other protected veteran in accordance with applicable federal state and local laws and any other characteristic protected by law.

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Job Exempt