Director – Medical Data Review
Location: Hyderabad, India
Company: Amgen
Employment Type: Full-Time
Job Summary
The Director – Medical Data Review (MDR) is a strategic leadership role responsible for defining, building, and scaling Amgen’s enterprise-wide Medical Data Review function across all therapeutic areas and phases of clinical development. The role drives the future-state vision for clinical data review by integrating advanced analytics, artificial intelligence (AI), automation, predictive risk management, and risk-based quality management (RBQM) principles.
This position provides strategic oversight for medical data quality, clinical risk management, inspection readiness, and operational excellence while partnering with senior leaders across Clinical Operations, Data Management, Safety, Biostatistics, Digital, and Medical functions. The Director will establish scalable operating models, governance frameworks, and organizational capabilities that enable proactive, data-driven clinical oversight and informed decision-making across the global development portfolio.
Key Responsibilities
Enterprise Medical Data Review Strategy
Define and execute the enterprise-wide vision, strategy, and multi-year roadmap for Medical Data Review (MDR).
Establish scalable operating models that support global clinical development programs across all therapeutic areas.
Align MDR strategy with overall R&D, clinical development, and patient safety objectives.
Drive organizational transformation initiatives to modernize medical data review capabilities.
Clinical Risk Management & Oversight
Lead enterprise-wide risk-based clinical oversight strategies.
Develop and implement proactive risk identification, monitoring, and mitigation frameworks.
Establish clinical risk thresholds, escalation pathways, and governance processes.
Ensure effective integration of MDR activities within Risk-Based Quality Management (RBQM) frameworks.
Medical Data Quality & Governance
Establish and govern enterprise standards for clinical data review quality, consistency, and compliance.
Define Key Performance Indicators (KPIs), quality metrics, and performance benchmarks.
Monitor organizational performance and drive continuous improvement initiatives.
Ensure high-quality, clinically meaningful, and inspection-ready data review processes.
AI, Automation & Advanced Analytics
Lead adoption and scaling of:
Artificial Intelligence (AI)
Machine Learning (ML)
Predictive Risk Modeling
Automated Data Review Solutions
Advanced Clinical Analytics Platforms
Drive innovation through technology-enabled review capabilities.
Evaluate emerging industry trends and integrate innovative solutions into MDR operations.
Promote data-driven decision-making across clinical development programs.
Cross-Functional Leadership
Partner with senior leadership across:
Clinical Operations
Clinical Development
Medical Monitoring
Data Management
Biostatistics
Pharmacovigilance / Safety
Regulatory Affairs
Digital & Technology Teams
Resolve enterprise-level trade-offs involving quality, timelines, resources, costs, and risks.
Foster strategic alignment across global clinical development functions.
Organizational Leadership & Talent Development
Provide leadership for the global Medical Data Review organization.
Develop workforce strategies, capability-building initiatives, and succession planning programs.
Design scalable organizational structures to support future business growth.
Mentor and develop leaders within the MDR function.
Foster a culture of accountability, innovation, quality, and risk-based decision-making.
Governance & Inspection Readiness
Establish governance frameworks overseeing:
Medical Data Review Quality
Clinical Risk Management
Operational Performance
Continuous Improvement
Own enterprise inspection readiness strategy related to clinical data quality.
Ensure regulatory compliance and traceability of review decisions.
Lead executive-level issue escalation and remediation activities.
Support global regulatory inspections and audits.
Operational Excellence
Drive trial delivery predictability through standardized yet flexible review processes.
Implement performance management frameworks based on operational data and business outcomes.
Improve efficiency, scalability, and effectiveness of clinical review operations.
Lead enterprise-wide process optimization initiatives.
Required Qualifications
Education
One of the following:
MD (Doctor of Medicine)
PharmD
PhD
Doctorate in Life Sciences or Related Discipline
Master's Degree in Life Sciences, Clinical Research, Public Health, Pharmacy, or Related Scientific Discipline
Experience
Approximately 18+ years of experience within:
Clinical Development
Clinical Research
Medical Monitoring
Medical Data Review
Drug Development
Pharmaceutical or Biotechnology Industry
Minimum 9+ years of experience in Medical Monitoring and/or Clinical Data Review.
Significant experience leading global teams and enterprise-level initiatives.
Prior people management experience with direct reports and leadership responsibilities.
Proven success leading clinical trial process improvement and data quality initiatives.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
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Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
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Boulder | Denver | Westminster |Connecticut :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Lisbon | Oeiras | Portugal |WI :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
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Gottingen | Hannover | Leipzig |Saxony Anhalt :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Wavre |Tipperary :
Ballydine |Cork :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
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Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
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Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Netanya | Yavne | Tel Aviv | Kfar Saba | Be'Er Sheva |Remote :
Green Way | Switzerland | French | Ireland | Lenexa | Melbourne | Blue Bell | Remote - Africa | Bountiful | Regulatory Labeling Manager (NA and LATAM Only) | Bishop | Medan | Remote - Europe | Texas | Victoria | Thailand | Belgium | Springville | Zaragoza | Perth | Hungary | Milwaukee | Remote - South America (Latin Americal) | Tulsa | Leinster | Remote - Middle East | Xzagreb | Slovakia | Hammond | Minnesota | Nairobi | Manipal | Faridabad | Riga | McFarland | Castlebar | Lousiana |Republic of Colombia :
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Ciudad de México | New Mexico |Dubai :
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Jeddah | Khulais | Rabigh | Najran | King Abdullah Economic City | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
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