Associate Director, Evidence Generation Study Execution & Data Group Lead

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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