Global Biomarker Lead, Rare Disease

🕒 Julho 7

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $166.523 - $225.296 / ano

⏰ Tempo Integral

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

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

• Lead the development and execution of robust program-specific clinical biomarker strategies to inform target engagement, pharmacodynamics, mechanism of action, and patient selection across early and late stage programs • Serve as precision medicine subject matter expert within product evidence generation teams to deliver precision medicine and translational medicine approaches to enable strategic alignment and delivery of high-quality biomarker datasets • Responsible for biomarker elements in clinical protocols, biomarker analysis plans, regulatory submissions, investigator meetings, advisory boards and publications • Lead and partner with biomarker technical sub-teams to plan all components of clinical biomarker strategy implementation including specialty vendor evaluations, biomarker budget and contract planning, biomarker and pharmacodynamic sample operations, biomarker data analysis plans, and cross-functional data sharing. • Interpret and communicate key clinical biomarker findings in an impactful way to cross functional and non-technical stakeholders, including Precision Medicine teams, product teams, R&D leadership, external scientific congresses, and lay audiences. • Establish and implement biomarker studies and collaborations with academic laboratories/KOLs

🎯 Requisitos

• Doctorate degree in a bioscience or medical discipline and 3+ years of industry experience • Or Master’s degree in a bioscience or medical discipline and 6+ years of industry experience • Or Bachelor’s degree in a bioscience or medical discipline and 8+ years of industry experience • PhD in a relevant field; PharmD, MD, or equivalent considered. • Minimum 5+ years of relevant experience, ideally in industry • Strong expertise in rare disease, autoimmunity, inflammation, cell biology, and genomics • Strong written and verbal communication skills with experience drafting technical reports, clinical documents, and biomarker publications, • Experience implementing a broad array of biomarker platforms and technologies including biomarker assay development and qualification • Experience in managing direct and dotted line reports, as well as matrix management of staff through team leadership • Experience working effectively in a globally dispersed team environment with cross-cultural partners • Experience with global programs and regulatory filings (IND/CTA/NDAs) is a plus.

🏖️ 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.