[Hiring] Senior Manager, Biobank @Amgen

Role Description

Join Amgen’s Mission of Serving Patients. In this vital role you will be part of the larger corporate mission of bringing medicines to patients with unmet medical needs every day. In this key role as a Manager, Biological Sample Management and Biobank, you will help us exceed productivity goals and deliver against our operational goals. Our scale is global and supports our clinical trials around the world. Please join an outstanding team that delivers for our stakeholders!

You will be responsible for supporting biobank activities for all clinical programs and contribute toward optimizing workstreams functionally throughout the organization as it relates to biospecimens. Some of the position’s key responsibilities include:

• Serve as the senior escalation authority for complex informed consent and biospecimen governance matters, providing final interpretation of participant intent and partnering with Institutional Review Boards and Ethics Committees to enable compliant and efficient study start-up.
• Establish and maintain the enterprise governance framework for informed consent templates related to biospecimen collection, retention, and reuse, ensuring alignment across clinical programs and evolving global regulatory expectations.
• Lead and develop a multi-layered operating model across internal staff and FSP partners, ensuring appropriate segmentation of transactional, rules-based, and judgment-driven work while driving overall operational performance.
• Identify systemic gaps across the biospecimen lifecycle and lead cross-functional initiatives to implement scalable solutions that improve cost efficiency, turnaround time, and governance quality.
• Own the strategic direction of biobank operations, including inventory optimization, long-term storage and disposition strategy, and advancement of key transformation initiatives aligned with the future-state operating model.
• Set vendor and supplier strategy for long-term storage and biobank services, including selection, performance oversight, and alignment with enterprise cost and capacity planning goals.
• Provide executive oversight of biospecimen transfer activities supporting in-licensing and out-licensing, ensuring risk mitigation, compliance, and seamless integration with broader R&D transactions.
• Ensure inspection readiness and governance oversight for nonclinical biospecimen management under GLP, reinforcing quality systems and regulatory compliance expectations.
• Define and drive capability-building strategy across the biobank function, including training frameworks, escalation pathways, and role clarity to support the evolving governance and program leadership model.

Qualifications

• Doctorate degree PhD OR PharmD OR MD and 3 years of industry experience in clinical trials and/or biospecimen management OR
• Master’s degree and 6 years of industry experience in clinical trials and/or biospecimen management OR
• Bachelor’s degree and 8 years of industry experience in clinical trials and/or biospecimen management

Requirements

• 7+ years work experience in clinical research setting in Pharmaceutical, Medical Devices, Clinical/Diagnostics areas, and/or contract research laboratories.
• Knowledge and functional expertise in R&D, particularly specimen management and biobanking.
• Knowledge of Good Clinical Practices (GCP), ICH and FDA guidelines for clinical trials.
• Evidence of strong project management skills.
• Exceptional verbal and written communication skills and experience navigating a matrixed organization.
• Experience with informed consent regulations related to biospecimens.
• Experience with Laboratory Information Management Systems (LIMS).
• Working knowledge of document management applications and study planning tools (e.g., Planisware, Documentum, Veeva platform, etc).
• Ability to develop collaborative internal and external relationships.
• Excellent interpersonal, organizational, and critical thinking skills.

Benefits

• 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 where possible.