Director – Medical Data Review
Department: Global Clinical Development
Location: Hyderabad, India
Company: Amgen
Job ID: R-245990
Reporting To: Senior Director / Executive Director – Clinical Development
Experience: 18+ Years
Education: MD / MBBS / PharmD / Master's / Doctorate in Life Sciences, Clinical Research, Pharmacy, Public Health, or related discipline
Role Summary
The Director – Medical Data Review is accountable for defining and executing the enterprise-wide strategy for Medical Data Review (MDR), clinical data quality, and risk-based clinical oversight across all therapeutic areas and development phases.
The role leads the transformation of traditional medical review processes into scalable, technology-enabled, AI-assisted clinical oversight capabilities that support patient safety, regulatory compliance, and accelerated clinical development.
This position serves as a strategic leader across Clinical Operations, Data Management, Medical Monitoring, Pharmacovigilance, Biostatistics, and Digital Innovation functions.
Strategic Leadership Responsibilities
1. Enterprise Medical Data Review Strategy
Define and execute the global vision and multi-year roadmap for Medical Data Review.
Develop future-state operating models for:
Medical Review
Risk-Based Quality Management (RBQM)
Integrated Data Review
Predictive Risk Management
Align MDR strategy with enterprise R&D objectives.
2. Clinical Data Quality & Risk Management
Establish enterprise-wide quality frameworks.
Define:
Review standards
Quality benchmarks
Risk thresholds
Governance processes
Ensure consistent clinical data review practices across the development portfolio.
Drive proactive identification and mitigation of clinical risks.
3. AI, Automation & Digital Transformation
Lead adoption of:
Artificial Intelligence (AI)
Machine Learning (ML)
Advanced Analytics
Predictive Risk Models
Automated Signal Detection Systems
Implement technology-enabled review processes to improve quality and efficiency.
Evaluate emerging digital innovations and translate them into operational capabilities.
4. Cross-Functional Enterprise Leadership
Partner with senior leaders across:
Clinical Operations
Clinical Development
Medical Monitoring
Data Management
Biostatistics
Pharmacovigilance
Regulatory Affairs
Digital & Technology Organizations
Drive alignment across quality, timelines, cost, and risk objectives.
5. Governance & Oversight
Establish executive-level governance structures.
Lead portfolio-wide review forums.
Provide oversight of:
Clinical data quality
Medical review effectiveness
Safety signal management
Risk escalation pathways
Ensure organizational accountability and transparency.
6. Organizational Leadership
Lead and develop global MDR teams.
Drive:
Workforce planning
Talent acquisition
Capability development
Succession planning
Build scalable operating models to support global studies.
7. Inspection Readiness & Compliance
Own the enterprise strategy for inspection readiness.
Ensure:
Audit-ready documentation
Traceability of medical review decisions
Regulatory compliance
Risk-based oversight practices
Support regulatory inspections and executive issue management.
8. Operational Excellence
Implement performance management frameworks.
Establish enterprise KPIs and metrics.
Drive process optimization and standardization initiatives.
Improve study execution predictability and efficiency.
9. Innovation & Continuous Improvement
Monitor industry best practices and emerging trends.
Champion innovation in:
Clinical Data Sciences
Medical Monitoring
Risk-Based Monitoring
Data Visualization
AI-enabled Clinical Development
Translate innovations into measurable business outcomes.
Key Performance Indicators (KPIs)
Clinical data quality metrics
Safety signal detection effectiveness
Risk identification and mitigation outcomes
Inspection readiness performance
Study delivery predictability
AI and automation adoption metrics
Team capability development
Organizational productivity improvements
Stakeholder satisfaction
Required Qualifications
Education
MD (Preferred)
MBBS
PharmD
Master's Degree
Doctorate (PhD)
Experience
Approximately 18+ years in:
Clinical Development
Medical Monitoring
Medical Review
Clinical Operations
Pharmacovigilance
Clinical Data Sciences
Minimum 9+ years of experience in:
Medical Monitoring
Clinical Data Review
Safety Review
Demonstrated leadership of global teams and enterprise transformation programs.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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