Medical Data Review Director Job at Amgen, Hyderabad
Looking for a leadership role in clinical research and medical data review with a global biotechnology leader? Amgen is seeking an experienced Director – Medical Data Review to join its Hyderabad team. This senior leadership position offers an exciting opportunity to shape enterprise-wide medical data review strategies, clinical data quality initiatives, and AI-enabled risk management programs across multiple therapeutic areas. The selected candidate for the Medical Data Review Director Job in Hyderabad will lead organizational transformation, clinical oversight, and innovation-driven data review capabilities, while contributing to Amgen’s mission to serve patients with serious illnesses. This role at Amgen Careers is ideal for professionals with extensive experience in medical monitoring, clinical development, and life sciences leadership.
About the Company:
Amgen is one of the world’s leading biotechnology companies dedicated to discovering, developing, manufacturing, and delivering innovative medicines for serious illnesses. Since its founding in 1980, Amgen has pioneered breakthroughs across Oncology, Inflammation, General Medicine, and Rare Diseases, helping millions of patients globally.
The company is recognized for its science-driven culture, commitment to innovation, and focus on improving patient outcomes through cutting-edge research and advanced technologies. Amgen continues to transform healthcare through its dedication to scientific excellence and patient-centered innovation.
Job Details:
- Position: Director Medical Data Review
- Job ID: R-245990
- Location: Hyderabad, India
- Work Location Type: On-Site
- Department: Clinical Development
- Employment Type: Full-Time
- Category: Clinical
- Industry: Biotechnology / Pharmaceutical Research
Key Responsibilities:
- Define and execute the enterprise-wide vision and strategy for Medical Data Review (MDR).
- Develop and implement multi-year roadmaps to transform clinical data review.
- Lead AI-assisted review, automation, predictive risk management, and RBQM initiatives.
- Establish enterprise standards, KPIs, quality benchmarks, and risk thresholds.
- Partner with Clinical Operations, Data Management, Safety, Medical Affairs, and Digital teams in this Medical Data Review Director Job.
- Drive strategic alignment across clinical development functions.
- Lead governance frameworks for data review quality and risk management.
- Oversee organizational design, workforce planning, and capability development.
- Ensure operational excellence and predictable clinical trial delivery.
- Evaluate emerging technologies and industry innovations in this Job in Hyderabad.
- Lead inspection-readiness and regulatory-compliance strategies.
- Drive adoption of advanced analytics, AI/ML capabilities, and predictive modeling tools.
- Build future-ready leadership capabilities within the MDR organization at Amgen Careers.
- Support continuous improvement and enterprise transformation initiatives.
Educational Requirements for this Medical Data Review Director Job:
- MD degree.
- Doctorate degree.
- Master’s degree in a relevant life sciences discipline.
- Advanced medical, scientific, or clinical qualifications preferred.
Eligibility Criteria:
- MD with 18 years of industry experience
- Doctorate, approximately 18 years of industry experience
- Master’s Degree, approximately 18 years of industry experience
Skills Required:
- Clinical Data Review expertise.
- Medical Monitoring experience.
- Clinical Development leadership.
- Medical Affairs and Clinical Operations knowledge.
- Risk-Based Quality Management (RBQM).
- Clinical trial oversight and governance.
- AI and automation implementation experience.
- Strategic leadership and organizational transformation.
- Data quality management and compliance expertise.
- Advanced analytics and predictive risk modeling.
- Strong communication and presentation skills.
- Cross-functional stakeholder management.
- Resource planning and team leadership.
- Inspection readiness and regulatory compliance.
- Advanced proficiency in Spotfire or equivalent clinical data analysis tools.
Benefits of the Medical Data Review Director Job:
- Leadership opportunity with a globally recognized biotechnology company.
- Exposure to enterprise-wide clinical development strategies.
- Opportunity to lead AI-driven healthcare innovation initiatives.
- Work on cutting-edge clinical research and medical data review programs.
- Collaborate with global scientific and clinical leaders.
- Drive transformational projects impacting patient outcomes worldwide.
- Access to advanced technologies and data analytics platforms.
- Career growth within a leading biopharmaceutical organization.
- Opportunity to influence global clinical quality and risk management practices.
- Work in a collaborative, science-based, and innovation-focused environment.
- Contribute directly to Amgen’s mission of serving patients with serious illnesses.
