Amgen is looking to solve the problem of delivering transformative therapies by ensuring scientific integrity, operational excellence, and meaningful impact on patient outcomes through effective biospecimen operations.
Requirements
- Doctorate degree in life sciences, clinical research, operations management, or a related field and 2 years of progressively responsible experience in biospecimen operations, clinical operations, or translational sciences
- Master’s degree life sciences, clinical research, operations management, or a related field and 4 years of progressively responsible experience in biospecimen operations, clinical operations, or translational sciences
- Bachelor’s degree life sciences, clinical research, operations management, or a related field and 6 years of progressively responsible experience in biospecimen operations, clinical operations, or translational sciences
- Solid knowledge of cGXPs, SOPs, and international regulatory requirements relevant to biospecimen handling.
- Proficiency in data and portfolio management tools (e.g., Smartsheet, PowerBI, analytics solutions).
- Experience with LIMS, digital tracking platforms, and other biospecimen management systems.
- Knowledge of emerging technologies and digital solutions in biospecimen management.
Responsibilities
- Lead the strategic direction of biospecimen operations across a Therapeutic Area, directly enabling Amgen’s ability to deliver transformative therapies.
- Provide strategic and operational oversight of biospecimen activities for Amgen clinical trials across a diverse portfolio of programs.
- Shape forward-looking sampling and testing plans that enable in-trial decision-making, translational research, and long-term scientific insights.
- Champion innovation in biospecimen management by introducing best practices, emerging technologies, and digital solutions that improve efficiency, data integrity, and inspection readiness.
- Act as a thought partner and strategic advisor in governance settings, ensuring biospecimen strategy aligns with enterprise-level priorities.
- Influence technology and systems alignment (e.g., LIMS, digital tracking platforms) to ensure biospecimen data integrity and operational efficiency.
- Ensure regulatory inspection readiness and compliance with global health authority expectations for biospecimen processes.
Other
- 12–15 years of experience in biospecimen management, clinical operations, or translational sciences, with increasing responsibility and demonstrated ability to influence senior leadership (executive directors, VPs).
- Demonstrated ability to provide strategic recommendations and influence decision-making in cross-functional governance settings.
- Strong experience in cross-TA program management and vendor partnerships.
- Exceptional communication, stakeholder management, and executive presence
- Ability to drive innovation and inspire high-performing teams
