Job Description

By clicking the xe2x80x9cApplyxe2x80x9d button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedaxe2x80x99s and . I further attest that all information I submit in my employment application is true to the best of my knowledge.The Future Begins HereAt Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet.Bengaluru, the city, which is Indiaxe2x80x99s epicenter of Innovation, has been selected to be home to Takedaxe2x80x99s recently launched Innovation Capability Center. We invite you to join our digital transformation journey. In this role, you will have the opportunity to boost your skills and become the heart of an innovative engine that is contributing to global impact and improvement.At Takedaxe2x80x99s ICC we Unite in DiversityTakeda is committed to creating an inclusive and collaborative workplace, where individuals are recognized for their backgrounds and abilities they bring to our company. We are continuously improving our collaborators journey in Takeda, and we welcome applications from all qualified candidates. Here, you will feel welcomed, respected, and valued as an important contributor to our diverse team.As the R&D and Clinical Data Product Lead at Takeda, you will be responsible for managing the data product strategy for end-to-end Clinical Trial data focusing on complete set of information collected, managed, and analyzed throughout the lifecycle. The responsibility includes designing and building data products that drive business insights, regional and global trial effectiveness, and market strategies. You will own the product lifecycle for data solutions that support Takedaxe2x80x99s Clinical, Regulatory and Patient including Trial operations data like adverse events, lab data, trial results, reporting, statistical analysis and reporting, study design and protocol and regulatory data like health authority interactions, regulatory authorization, Labeling & Packaging, submissions etc. Working closely with cross-functional teams such as Global and Local R&D Teams, Regulatory Teams, Quality Teams, Insight and Analytics (I&A), Data Science, and IT, you will ensure that the data products provide actionable insights to maximize business value and improve decision-making. Our Enterprise Data Backbone (EDB) is built on a trusted data marketplace experience and will be key to accelerating data availability to our business partners. This role will report to the Head of Data Products.Required Technical Expertise: In-depth domain knowledge of end-to-end clinical trial, regulatory processes and RWE and RWD data, to enhance operational efficiency and compliance.Key Responsibilities:

• Product Vision & Strategy: Define and execute the vision and strategy for Takedaxe2x80x99s 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:Education:

• Bachelorxe2x80x99s degree in data science, Business, Marketing, or a related field.
• Masterxe2x80x99s 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.

What Takeda Can Offer You

• Takeda is certified as a Top Employer, not only in India, but also globally. No investment we make pays greater dividends than taking good care of our people.
• At Takeda, you take the lead on building and shaping your own career.
• Joining the ICC in Bangalore will give you access to high-end technology, continuous training and a diverse and inclusive network of colleagues who will support your career growth.

BenefitsIt is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:Competitive Salary + Performance Annual Bonus

• Flexible work environment, including hybrid working
• Comprehensive Healthcare Insurance Plans for self, spouse, and children
• Group Term Life Insurance and Group Accident Insurance programs
• Health & Wellness programs
• Employee Assistance Program
• 3 days of leave every year for Voluntary Service in additional to Humanitarian Leaves
• Broad Variety of learning platforms
• Diversity, Equity, and Inclusion Programs
• Reimbursements xe2x80x93 Home Internet & Mobile Phone
• Employee Referral Program
• Leaves xe2x80x93 Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 days)

About ICC in Takeda

• Takeda is leading a digital revolution. Wexe2x80x99re not just transforming our company; wexe2x80x99re improving the lives of millions of patients who rely on our medicines every day.
• As an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.

#Li-HybridLocations IND - BengaluruWorker Type EmployeeWorker Sub-Type RegularTime Type Full time

Takeda