Associate Director, Evidence Generation Study Execution & Data Group Lead Bengaluru, Karnataka Category: Data Sciences

Job description

Associate Director, Evidence Generation Study Execution & Data Group Lead Bengaluru, Karnataka Apply Now Job ID R0191899 Category Data Sciences Subcategory Research & Development Business Unit Global Portfolio Division Job Type Full time By clicking the “Apply” 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 Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Role Objectives : • Lead the Evidence Generation Study Execution & Data capability within the Bengaluru GCM, overseeing governance records and systems operations, AI-enabled surveillance, RWD data operations, statistics and analysis, post-hoc / SAP trial-data analysis, internal study execution and study-development support • Establish a scalable operating model that delivers high-quality operational execution, documentation, coordination, analytics support, and repository discipline that enables Global Evidence Generation and RWD leadership to focus on scientific strategy, methodology, interpretation, and final decision-making Key Responsibilities : Capability Leadership & Operating Model Build • Establish operating rhythms, role clarity, escalation pathways, and quality expectations across the Study Execution & Data GCM teams • Oversee team delivery across governance records and systems operations, AI-enabled surveillance, RWD data ingestion and quality, statistics and analysis, post-hoc trial-data analysis, internal study execution and study-development support • Manage daily workflows for manager level roles related to RWD activities including data ingestion and analysis • Define capacity plans, intake rules, workload allocation, and handoff protocols with Global Evidence Generation, RWD CoE, DD&T, R&D, I&A, LOCs, and other partners • Ensure GCM execution remains within approved scope while strategic judgment, scientific interpretation, methodology decisions, and final approvals remain with US owners Data, AI & Systems Oversight • Oversee evidence data governance support, repository validation, data access assessment, systems roadmap implementation support, and AI-enabled literature surveillance • Ensure data governance and systems activities follow defined metadata, access, version-control, retention, and audit-readiness standards • Partner with DD&T, R&D, and I&A to support implementation planning, testing, readiness, communication, and change documentation for Evidence Generation systems and data capabilities • Monitor risks related to data access, repository quality, system dependencies, AI output traceability, and unresolved technical or governance issues Study Execution & Analytical Delivery Oversight • Oversee GCM support for statistics and analysis, post-hoc / SAP trial-data analysis, internal study execution, evidence-source landscaping, protocol / synopsis support and study-execution documentation • Ensure analytical and study execution outputs include documented assumptions, limitations, QC evidence, reproducibility records, and escalation notes • Support standardization of templates, trackers, output shells, review packages, and documentation workflows • Escalate methodology changes, interpretation questions, scientific issues, regulatory / HTA implications, and strategic tradeoffs to Global Evidence Generation owners Team & Stakeholder Management • Lead and develop Senior Managers and Manager-level ICs; support onboarding, training, coaching, and capability maturation • Serve as the senior GCM contact for Study Execution & Data delivery, providing status reporting on capacity, quality, backlog, risks, and transition readiness • Drive continuous improvement, automation adoption where approved, and process standardization across the capability Qualifications : Experience: >8 years of related work experience; >4 years of experience in the biopharmaceutical industry; >4 years in evidence generation, RWE / HEOR, clinical operations, study execution, data governance, analytics operations, or medical affairs operations. Experience managing teams or senior individual contributors preferred. Technical skills: • Strong understanding of evidence generation study execution, RWD / HEOR operations, data governance, study systems, and analytical delivery workflows • Ability to lead cross-functional delivery across Global Evidence Generation, RWD CoE, DD&T, R&D, I&A, LOCs, and vendors • Knowledge of study documentation, repository governance, QC evidence, audit readiness, and controlled analytics environments • Familiarity with RWD data sources, study systems, AI-enabled surveillance, SAS / R / SQL workflows, Veeva, iEnvision, or equivalent platforms preferred • Strong stakeholder management, operational governance, and process scale-up skills Education: A scientific, medical, life sciences, pharmacy, public health, epidemiology, biostatistics, data science, or health economics degree is required; advanced degree preferred Languages: Fluent English required; additional languages advantageous Locations IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time Apply Now Share this job Facebook Xing LinkedIn Email Related content Learn more Frequently Asked Questions Learn more Healthcare for all Learn more How We Partner Learn more Innovators in Science Award Winners Learn more Luck is not a strategy Learn more Takeda Unveils Newly Renovated Cambridge Building Learn more Our Commitment to the Planet Learn more Our Products Learn more Our R&D Pipeline Learn more Patient Story: Rosie Learn more Putting Patients First Learn more Sustainable Value Report 2023 Learn more Takeda Global Headquarters Learn more Takeda in the US Learn more Takeda’s Global CSR Program Learn more The History of Takeda Learn more Values and Corporate Governance Learn more Takeda Manufacturing - 2021 Facilities of the Year Learn more Takeda Acquires Adaptate Therapeutics Learn more BioLife Plasma Services Learn more Biotech Site in Covington, GA Learn more Takeda’s Position on Climate Change Learn more Corporate Responsibility Learn more Diversity, Equity and Inclusion Learn more <li class="js-hub-item hub-content__item showing-by-filter showing-by-load" data-hub-read-time="" data-hub-origin="False" data-hub-title="Loni's Data Science Story" data-hub-meta-title="" data-hub-meta="Explore more." data-hub-url="jobs.takeda.com/" data-hub-isfallbackpage="False" data-hub-order="0" data-hub-link="https://www.takeda.com/our-stories/all-stories/" data-hub-image="https://tbcdn.talentbrew.com/company/1113/v3_0/img/rc-data-science-story.jpg" data-hub-created-by="TMP created" data-hub-date-updated="02/26/2025 19:36:58" data-hub-date-created="02/26/2025 19:36:58" data-hub-date-overri