Senior Manager, Biobank

🕒 Maio 1

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $137.365 - $185.848 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Biotechnology • Pharmaceuticals • Science

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• 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

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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.