Product Vision & Strategy: Define and execute the vision and strategy for Takeda’s R&D, Regulatory data products, ensuring alignment with business objectives. Lead data products internalization and building Community of Practice (CoP). Provide holistic viewpoint for both R&D, Regulatory, Marketing and Commercial processes.
Data Integration & Management: Oversee the end-to-end build of data products from multiple sources, R&D and Regulatory systems, Trial Ops data, and Site Management, ensuring FAIR principles are applied across the organization.
Data Management and Analysis: Analyze pharmaceutical data to generate insights and improve decision-making. Ensure data integrity and regulatory compliance in all activities.
Roadmap Development: Develop and manage a comprehensive product roadmap that prioritizes features based on business impact, user needs, and technical feasibility. Ensure the roadmap supports R&D goals and drives data-driven decision-making.
Cross-Functional Collaboration: Work closely with business and IT stakeholders across Global and Regional Teams, Trial and Regulatory Operations, Sales, Marketing, Data Science, and IT to gather requirements and define data needs, ensuring alignment with business objectives.
Data Governance & Compliance: Ensure that all data products adhere to internal governance frameworks and external regulations (e.g., GDPR, CCPA, CFR11). Implement best practices for data privacy and security, especially regarding customer data.
End-to-End Data Flow: Map out the end-to-end data flow across applications and platforms, ensuring seamless integration with internal systems and external partners (CROs, Labs etc.), enabling a unified view of R&D and Regulatory data.
Analytics & Insights: Collaborate with Data Science and Analytics teams to develop reporting tools and dashboards that provide actionable insights into trends, trial effectiveness, patient behavior, and clinical trial performance.
Vendor Management: Manage relationships with third-party data providers and technology vendors to ensure timely delivery, data quality, and adherence to service level agreements (SLAs).
Process Improvement: Identify opportunities to enhance data processes, including data collection, validation, and analysis. Implement solutions to improve the efficiency and accuracy of trial ops, site management, regulatory and clinical trial data.
Data Quality & Security: Ensure the highest standards of data quality and security, implementing data validation processes and monitoring systems to safeguard sensitive patient, clinical trial and customer information.
User Experience: Enhance the user experience for various teams by providing easy access to real-time data and insights through intuitive dashboards and self-service analytics tools.
Stakeholder Engagement: Act as the primary advocate for R&D, Regulatory, Site Management, Reporting, Biostatistics and Analytics teams, ensuring alignment and facilitating ongoing feedback to improve the data products.
Qualifications
Bachelor’s degree in data science, Business, Marketing, or a related field.
Master’s degree preferred.
Experience:
10+ years of experience in Clinical / R&D IT across various domains including study setup, EHR/EMR data, Clinical Trial data, Clinical trial statistic and analysis, product ownership, data management, and regulatory operations within the pharmaceutical, healthcare, or biotechnology industry.
Proven experience in building data products with the data related to clinical trial and operations, adverse events, Lab data, and regulatory authorization and submissions.
Understanding of quality control and assurance processes, compliance with regulatory standards (e.g., GMP, CFR11), deviation reports, audit findings, medical coding and standards.
Understanding of clinical trial milestones, deliverables and FDA submissions processes.
Proven experience with data products development utilizing data from different clinical and R&D platform (e.g., CTMS, CDMS, EDC, EMR, Standards Management etc.) and external data vendors (CRO, Lab etc.) and managing large-scale data integration projects.
Strong understanding of regulatory processes and their data needs.
Skills & Competencies:
Expertise in clinical data management, data integration, and governance in a R&D and Regulatory context.
Strong knowledge of data analytics, visualization and programming tools (e.g., Tableau, Power BI, SAS, R).
Experience with cloud computing platforms (e.g., AWS, Azure) and database systems.
Excellent project management and organizational skills, with experience working in Agile or Scrum environments.
Strong communication and interpersonal skills to collaborate effectively across business functions and technical teams.
Preferred Knowledge:
Familiarity with commercial domain and patient data.
Experience with predictive analytics, machine learning, or AI applications in clinical trials.
Knowledge of the pharmaceutical commercial operations.
