PHARMAFull time
Lead Medical Data Reviewer
By Admin · Clinical Data Management
HYDERABAD (IN)ONSITEPOSTED: 11/6/2026
PHARMAFull time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE OVERVIEW
Amgen is seeking a Lead Medical Data Reviewer in Hyderabad to own project- or molecule-level medical data review strategy across assigned clinical studies. The role integrates cross-study medical review findings and supports risk-based medical monitoring.
ROLE DEFINITION & RESPONSIBILITIES
- •Define and maintain project- or molecule-level 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, with approaches tailored to phase, indication, modality and study risk.
- •Provide cross-study medical-interpretation inputs for risk-based, fit-for-purpose Medical Monitoring Plans while preserving Medical Monitor accountability.
- •Synthesize participant-level and aggregate patterns across studies into an integrated project or molecule risk view and recommend follow-up, trade-offs or escalation.
- •Resolve complex cross-study MDR issues by convening Medical Monitors, Clinical Scientists, Safety, Data Management, Clinical Operations, Biostatistics, Quality and other experts.
- •Set project-level requirements for Spotfire views, analytics, programmed checks and approved digital or AI-enabled capabilities, confirming medical fitness for purpose and scalability.
- •Assess MDR readiness for interim analyses, database locks, submissions, audits, inspections, transitions and other critical milestones.
- •Provide technical direction to Senior Medical Data Reviewers and Medical Data Reviewers, calibrate clinical reasoning and review standards, and support mentoring without line-management duties.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- MD/Diploma with 3–5 years of relevant experience, or MBBS from an MCI/NMC-recognized medical institution in India with 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.
PREFERRED QUALIFICATIONS
- •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.
REQUIRED VERIFIED SKILLS
Medical data review
Medical monitoring
Pharmacovigilance
Clinical development
IDRP strategy
Risk-based review
Spotfire
Programmed checks
AI literacy in clinical development
Cross-study clinical judgment
Integrated risk synthesis
Technical mentoring and calibration
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Amgen researches, develops and delivers innovative medicines, combining science, technology and its people. The company focuses on patients living with serious illnesses.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
APPLICATION ADVISORY
Highlight your ownership of complex MDR delivery across multiple studies or a molecule, with concrete examples of cross-study risk synthesis and influence in senior cross-functional forums. Make your qualification path clear: MD/Diploma with 3–5 years or MBBS from an MCI/NMC-recognized Indian institution with 5–8 years in clinical development, medical data review, medical monitoring or pharmacovigilance. Mention experience with Spotfire, programmed checks, AI literacy and audit or inspection readiness where applicable.
SPONSORED · TRAINING
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