Associate Director, Evidence Generation Study Execution & Data Group Lead

Takeda · Healthcare & Pharma

Bengaluru, Karnātaka, India
On-site
Posted yesterday
Full time

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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

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