Amgen

Lead Medical Data Reviewer

Amgen  •  Hyderabad, IN (Hybrid)  •  4 months ago
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Job Description

Career Category

Clinical Development

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 with cross functional teams to deliver high-quality, decision-ready clinical data in support of Amgen’s 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 enabling appropriate TA-specific flexibility

  • Oversee overall MDR 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

  • Identify and resolve systemic, cross-TA issues impacting data 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 expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 12+ years of life sciences/healthcare experience

OR

Master’s 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, including significant experience in 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 communication and presentation skills (written and oral)

  • Deep understanding of operational aspects of clinical data review

  • Advanced proficiency with clinical data analysis tools (e.g., Spotfire or equivalent)

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

  • Stock-based long-term incentives

  • Award-winning time-off plans

  • Flexible work models, including remote and hybrid work arrangements, where possible

Amgen

About Amgen

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.

Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.

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Industry
Biotech & Life Sciences
Company Size
10,000+ employees
Headquarters
Thousand Oaks, CA
Year Founded
1980
Website
amgen.com
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