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ABOUT THE ROLE

The Lead Medical Data Reviewer is accountable and responsible for project- or molecule-level MDR strategy and integrated outputs across assigned studies in the therapeutic areas. The role also holds study-level MDR accountability and overall accountability for project and study-level strategy and delivery. The Lead Medical Data Reviewer is accountable and responsible for the Project level MDR workstream for assigned study or studies. The role defines and delivers the study review strategy, integrates participant-level and aggregate findings, supplies scientific IDRP inputs, and provides clear medical-review insight to the Medical Monitoring Group and clinical study team.

ROLE DESCRIPTION

This is a senior expert individual-contributor role. The Lead Medical Data Reviewer owns project/molecule MDR strategy, cross-study scientific consistency, risk based fit for purpose medical monitoring strategy, and integrated medical data-review interpretation. The role also takes study-level accountability when assigned. The Medical Monitor retains accountable medical oversight and medical decisions; the Clinical Scientist supports scientific integrity and study execution.

ROLES AND RESPONSIBILITIES

·   Establish and maintain the project or molecule MDR strategy, across assigned studies, aligned with development objectives, product risks, critical-to-quality factors, and major milestones.

·   Set scientific expectations for IDRP strategy and inputs across studies; ensure approaches are consistent where useful and tailored to phase, indication, modality, and study risk.

·   Provide cross-study medical-interpretation inputs that support risk based fit-for-purpose Medical Monitoring Plans as per IDRP, while preserving Medical Monitor accountability.

·   Synthesize participant-level and aggregate patterns across studies to form an integrated project or molecule risk view and recommend follow-up, trade-offs, or escalation.

·   Resolve complex MDR issues that cross study boundaries by bringing together the Medical Monitor, Clinical Scientist, Safety, Data Management, Clinical Operations, Biostatistics, Quality, and other relevant experts.

·   Set project-level requirements for Spotfire views, analytics, programmed checks, and approved digital or AI-enabled capabilities; confirm medical fitness for purpose and scalability.

·   Direct project-level use of ACT FAST/GDO Modernization and risk-based review; use quality, timeliness, adoption, and readiness evidence to prioritize improvement.

·   Assess MDR readiness for interim analyses, database locks, submissions, audits, inspections, transitions, and other critical project milestones.

·   Provide technical direction to Senior Medical Data Reviewers and Medical Data Reviewers, calibrate clinical reasoning and review standards, and support communities of practice without assuming line-management duties.

·   Map and maintain stakeholder relationships across the Medical Monitoring Group, study teams, Clinical Development, Data Management, Safety, Clinical Operations, Biostatistics, Regulatory, Quality, and technology teams.

·   Represent MDR in project or molecule governance and communicate integrated risks, recommendations, dependencies, and outcomes to senior stakeholders as applicable

·   Lead cross-study process and quality improvements and responsible for audits and inspection responses or corrective actions within MDR accountability, in partnership with accountable functional owners.

·   Overall accountable for Quality of the Trial, Project output.

·   Represents in cross department initiatives, drives and suggests changes to process/tools improvements, change management, and driving and leading scientific forums within medical data review and medical monitoring groups.

·   Share scientific and technical knowledge, support training, mentoring, onboarding, and provide constructive review feedback to MDRs.

·   Leads improving review quality, analytics, tools, processes, or capability without relying on formal authority.

·   Leads and drives BPO for MDR role when assigned as appropriate.

STAKEHOLDER RELATIONSHIPS AND ROLE BOUNDARIES

Connects study-level MDR work with project or molecule governance. The Lead Medical Data Reviewer aligns with Medical Monitors and Clinical Scientists, provides integrated MDR evidence, and ensures technical consistency. The role preserves the Medical Monitor’s accountable medical oversight and the Clinical Scientist’s assigned study-science responsibilities.

BASIC QUALIFICATIONS AND EXPERIENCE

·   MD/Diploma with 3-5 years of relevant experience

·   MBBS from an MCI/NMC-recognized medical institution in India 5-8 years of relevant experience 

·    Substantial relevant experience in clinical development, medical data review, medical monitoring, pharmacovigilance, or comparable clinical-data work.

·   Demonstrated responsibility for complex MDR delivery across multiple studies, a molecule, project, or program.

·   Evidence of cross-study clinical judgment, integrated risk synthesis, and influence in senior cross-functional forums.

·   Experience improving review quality, analytics, tools, processes, or capability without relying on formal authority.

·   Technology application knowledge with AI Literacy in Clinical Development Space

The role is senior-manager-equivalent in scope as an expert individual contributor; final GCF placement depends on sustained molecule/project accountability, complexity, influence, and competency evidence rather than qualification alone.

PREFERRED QUALIFICATIONS AND EXPERIENCE

·   Therapeutic-area depth in complex, early-development, registrational, or submission-critical programs.

·   Experience shaping cross-study IDRP strategy, Medical Monitoring Plan medical-interpretation inputs, integrated review, Spotfire, programmed checks, or governed AI requirements.

·   Broad understanding of the clinical-development value chain from protocol strategy through submission and evidence generation.

·   Experience supporting process or capability governance and sustained adoption of new practices.

·   Demonstrated technical mentoring of experienced reviewers or study-responsible MDRs.

·   Knowledge of AI Literacy and its ethical applications in Clinical Development