Senior Manager, Biobank
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Manager, Biobank at Amgen overseeing clinical trials and biospecimen governance. Responsible for operational goals, framework compliance, and biobank activities across clinical programs.
Responsibilities:
- 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
Requirements:
- 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
- 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 (eg. 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
- 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.
Similar Jobs
Retail Media Manager
Retail Media Manager managing eRetail media campaigns for a leading marketing agency. Guiding clients' success on key platforms like Amazon and Mercado Livre.
Patient Access Liaison, Manager – Rare Disease
Field-based patient access liaison at Amgen supporting therapy access and reimbursement for patients. Collaborating with healthcare providers to navigate insurance coverage and support patient needs.
Senior Test Manager
Senior Consultant Test Manager leading testing strategy and execution for retail clients. Driving quality management and mentoring consultants within Spike's Quality Management practice.
Programme Test Manager – Principal
Principal Programme Test Manager at Spike delivering high-complexity testing programmes and innovative consultancy services for leading retail technology brands. Engage with stakeholders and lead teams to drive quality outcomes.
Manager, Cloud Threat Research
Manager leading cloud threat research team at Proofpoint. Focusing on email, BEC, ATO, OAuth, and AI threat research.
Brokerage Area Manager
Brokerage Area Manager at UPS leading customs brokerage operations and guiding teams for global trade compliance. Driving strategic direction and operational excellence in a remote capacity.
Data Strategy and Performance Manager
Data Strategy and Performance Manager at Empower measuring enterprise data strategy impact on financial outcomes. Responsibilities include executive communication and aligning metrics to business goals.
Senior Culinary Innovation Manager
International Culinary Innovation Manager leading product development and supporting culinary initiatives for the Dunkin’ brand across APAC markets.
International Business Manager
International Business Manager overseeing franchisee operations primarily in Japan and Korea for a multi-brand restaurant company. Responsible for business growth, coaching, and relationship management.
Field Service Manager
Project Manager responsible for planning and executing projects at Oshkosh AeroTech. Leading cross-functional teams and ensuring project alignment with business objectives and regulatory requirements.
Manager, Real Estate – Facilities
Manager, Real Estate & Facilities at Cohere, combining strategic management and hands-on oversight. Directing lease negotiations, vendor relations, and budget management in the AI industry.
Behavioral Health Care Manager
Behavioral Health Care Manager providing evidence-based mental health treatment through telehealth for oncology patients. Integrating care in oncology clinics and collaborating with healthcare teams.
Construction Manager – Site Superintendent
Construction Manager overseeing commercial building construction activities, ensuring compliance and safety standards in Canada. Leading project execution and coordinating subcontractor efforts for successful project delivery.
Senior Contracts Manager
Senior Contracts Manager leading contracting phases and vendor selection for energy solutions provider. Collaborating with cross-functional teams to enhance value and efficiency in procurement.
Complex Manager
Complex Manager at Root Insurance ensuring effective handling of liability investigations and claims processes. Leading a team to enhance the insurance experience driven by technology and automation.
Regional Manager
Regional Manager overseeing and mentoring Mobile Technicians in the Central Florida area for fleet mobile maintenance. Leading operations, driving productivity, and ensuring safety standards.
Reporting Manager
Reporting Manager overseeing financial records, ensuring accuracy and compliance at Nysonian. Responsible for financial reporting, audit support, and team mentorship in a dynamic environment.
Senior Product Group Manager
Senior Product Group Manager overseeing diverse product functions with enterprise-wide impact at TD. Leading talent development, strategic planning, and efficient product delivery across teams in NJ.
Senior Manager, Experience Strategy – Implementation
Senior Manager overseeing implementation strategies for Fortune 1000 clients at Wellist. Driving personalized activation and optimizing client program launches with measurable ROI.
Senior Manager, Data Insights
Senior Manager driving data architecture and insights for Docker's growth. Leading a team supporting engineering, product, and marketing data needs.