Associate Director, Evidence Generation Study Execution & Data Group Lead

IND - 2028 Takeda Innovations India Private Limited; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Takeda Innovations India Private Limited in Bengaluru seeks a senior leader to drive evidence generation study execution and data capability. You will oversee governance, AI-enabled surveillance, RWD data operations, statistics, and trial-data analysis, enabling scientific strategy with global partners.

The role requires 8+ years in biopharma data/operations, strong leadership, and a track record of cross-functional delivery. A scientific degree is required, with advanced degree preferred.

Qualifications

• 8+ years in related work, 4+ in biopharma, with evidence generation or data governance.
• Experience leading senior managers and cross-functional teams.
• Strong ability to define operating rhythms and governance standards.

Responsibilities

• Lead Study Execution & Data capability within Bengaluru GCM and oversee governance records.
• Manage AI-enabled surveillance, RWD data operations, stats and analysis activities.
• Oversee trial-data analysis, internal study execution, and study-development support.
• Define capacity, intake rules, workload allocation, and handoffs with partners.
• Ensure execution stays within scope while scientific decisions remain with US owners.
• Mentor senior managers, drive automation, and standardize processes.

Skills

Leadership

Stakeholder management

Operational governance

Cross-functional delivery

Automation adoption

Education

Science/Medical/Life Sciences degree

Advanced degree preferred

Tools

SAS

R

SQL

Veeva

iEnvision

Job description

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

About Takeda

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Equal Opportunity Employer

Takeda is an equal opportunity employer.

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