Lead Medical Data Reviewer
In this vital role,the Senior Manager, Medical Information (Medical Data Reviewer Lead) is accountable for the strategic and operational leadership of the Medical Data Reviewer (MDR) function across multiple Therapeutic Areas (TAs). This role ensures harmonized MDR practices across the portfolio while enabling TA-specific nuances and risk-based decision-making. The MDR Lead partners closely withcross functional teamstodeliver high-quality, decision-ready clinical data in support of Amgens development strategy.
- Provide strategic and operational leadership of the Medical Data Reviewer (MDR) function across assigned Therapeutic Areas, ensuring alignment with enterprise clinical development and data management strategies
- Partner with Therapeutic Area leadership, Clinical Operations, Clinical Data Management, Global Safety, and Data Digital teams to proactively manage risks, dependencies, and resourcing needs
- Drive standardization of MDR processes, quality frameworks, analytics, and tools while enablingappropriate TA-specificflexibility
- OverseeoverallMDR workload planning, capacity management, and prioritization to support study timelines, data quality, and inspection readiness
- Lead, mentor, and develop Senior MDRs, building leadership capability, strong judgment, and consistent performance across the MDR organization
- Identifyand resolve systemic, cross-TA issuesimpactingdata quality, review efficiency, or portfolio delivery
- Lead continuous improvement initiatives, including automation, advanced analytics, and new ways of working to enhance MDR effectiveness and scalability
- Represent the MDR function in governance forums, portfolio discussions, and cross-functional leadership meetings
What we expectofyou
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional weseekis a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 12+years of life sciences/healthcare experience
OR
Masters degree and 12+years of life sciences/healthcare experience
Preferred Qualifications:
- MD or equivalent
- 9+ years of experience in life sciences or a medically related field, includingsignificant experiencein medical monitoring and/or clinical data review
- Prior people management experience with direct reports
- Demonstrated strategic leadership of a clinical data review or medical monitoring function
- Experience leading clinical trial process improvement and data quality optimization initiatives
- Strong communicationand presentation skills (written and oral)
- Deep understanding of operational aspects of clinical data review
- Advancedproficiencywith clinical data analysis tools (e.g., Spotfire or equivalent)
