Director, Innovation, Global Regulatory Information Data & Systems
Takeda
Summary
The Director, Innovation leads the GRIDS Innovation Program, establishing and operationalizing a structured framework to capture, assess, prioritize, and deliver innovation and continuous improvement initiatives across Global Regulatory Affairs. This role ensures that innovation is managed as a disciplined capability, enabling both rapid improvements and strategic system advancements aligned with GRA and Digital strategy. The position drives transparency, governance, and value realization across the innovation lifecycle, strengthening organizational capability and fostering a culture of continuous improvement.
Job description
Objective / Purpose
The Director, Innovation leads the GRIDS Innovation Program, establishing and operationalizing a structured framework to capture, assess, prioritize, and deliver innovation and continuous improvement initiatives across Global Regulatory Affairs. This role ensures that innovation is managed as a disciplined capability, enabling both rapid improvements and strategic system advancements aligned with GRA and Digital strategy. The position drives transparency, governance, and value realization across the innovation lifecycle, strengthening organizational capability and fostering a culture of continuous improvement.
Accountabilities
- Lead and govern the end-to-end innovation lifecycle, including idea intake, assessment, prioritization, routing, and implementation
- Establish and operationalize standardized intake channels and governance structures for innovation management
- Ensure systematic capture of ideas from regulatory teams, audits, inspections, and external inputs
- Facilitate cross-functional prioritization governance, ensuring alignment to value, complexity, and strategic objectives
- Define and govern delivery pathways (e.g., system roadmap, rapid implementation, interim solutions)
- Monitor implementation progress and ensure alignment with delivery teams and organizational priorities
- Define and track KPIs to measure innovation outcomes, including efficiency, quality, and risk reduction
- Deliver transparent reporting to GRA and Digital leadership on pipeline health and performance
- Drive adoption of innovation processes and reinforce innovation behaviors across the organization
- Promote recognition and engagement to strengthen a culture of innovation and continuous improvement
Education & Experience
- Bachelor's degree required; advanced degree preferred
- 10+ years of experience in Regulatory Affairs, Operations, or Regulatory Technology/Data
- Experience establishing or leading innovation or governance frameworks in GxP environments
Technical Competencies
- Strong understanding of regulatory systems and data (RIM, submissions, IDMP, etc.)
- Experience with governance, prioritization, and portfolio management frameworks
- Knowledge of regulatory compliance considerations (GxP vs. non-GxP)
- Ability to align innovation initiatives to strategic and operational priorities
Behavioral & Leadership Competencies
- Strong executive stakeholder engagement and influence
- Ability to lead cross-functional governance forums and decision-making processes
- Data-driven mindset with focus on measurable outcomes and value realization
- Ability to balance structure and agility in innovation delivery
- Strong communication and storytelling capabilities for senior audiences
- Proven ability to drive cultural and behavioral change
Requirements
- Bachelor's degree required
- Advanced degree preferred
- 10+ years of experience in Regulatory Affairs, Operations, or Regulatory Technology/Data
- Experience establishing or leading innovation or governance frameworks in GxP environments
- Strong understanding of regulatory systems and data (RIM, submissions, IDMP, etc.)
- Experience with governance, prioritization, and portfolio management frameworks
- Knowledge of regulatory compliance considerations (GxP vs. non-GxP)
- Ability to align innovation initiatives to strategic and operational priorities
- Strong executive stakeholder engagement and influence
- Ability to lead cross-functional governance forums and decision-making processes
- Data-driven mindset with focus on measurable outcomes and value realization
- Ability to balance structure and agility in innovation delivery
- Strong communication and storytelling capabilities for senior audiences
- Proven ability to drive cultural and behavioral change
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.