Amgen is looking for a Biospecimen Strategy Lead to provide strategic and operational oversight of biospecimen activities for clinical trials, ensuring scientific integrity and operational excellence to enable the delivery of transformative therapies.
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 biospecisan 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
- Associate’s degree life sciences, clinical research, operations management, or a related field and 10 years of progressively responsible experience in biospecimen operations, clinical operations, or translational sciences
- High school diploma / GED and 12 years of progressively responsible experience in biospecimen operations, clinical operations, or translational sciences
- 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).
- Solid knowledge of cGXPs, SOPs, and international regulatory requirements relevant to biospecimen handling.
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.
- Ensure regulatory inspection readiness and compliance with global health authority expectations for biospecimen processes.
- Influencing technology and systems alignment (e.g., LIMS, digital tracking platforms) to ensure biospecimen data integrity and operational efficiency.
- Partnering in the management of strategic partnerships and alliances with external labs, biobanks, and vendors to support program success and long-term capability building.
Other
- Serve as a visible and trusted influencer to executive directors, VPs, and senior leaders, guiding decisions that impact scientific direction, portfolio execution, and patient outcomes.
- Inspire, mentor, and build biospecimen management capabilities across Amgen, shaping the next generation of leaders in this critical space.
- Represent Amgen externally in scientific forums, partnerships, and industry consortia, positioning the company as a leader in biospecimen strategy and execution.
- Partnering with senior leaders (PMLs, GBLs, PMed PMs) to define and deliver biospecimen strategies aligned with enterprise and TA priorities.
- Providing executive-level updates and shaping cross-TA strategy discussions.
