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Precision Medicine Global Biomarker Lead, Rare Disease

amgen

New
Senior 166,524 - 225,297 USD/year 🇬🇧 English
Biomarker assay development Genomics Regulatory filings (IND/CTA/NDAs)

Job description

About the role

Amgen's Precision Medicine Unit is looking for a senior principal scientist to act as Global Biomarker Lead for rare disease. The role drives biomarker strategies aligned with Precision Medicine goals, working with cross-functional product teams and overseeing assay readiness, vendor management and biomarker data interpretation.

Key responsibilities

  • Lead the development and execution of program-specific clinical biomarker strategies covering target engagement, pharmacodynamics, mechanism of action and patient selection across early and late stage programs.
  • Serve as precision medicine subject matter expert in product evidence generation teams, delivering high-quality biomarker datasets.
  • Own biomarker elements in clinical protocols, analysis plans, regulatory submissions, investigator meetings, advisory boards and publications.
  • Lead biomarker technical sub-teams on vendor evaluation, budget and contract planning, sample operations, data analysis plans and data sharing.
  • Interpret and communicate biomarker findings to technical and non-technical stakeholders, including R&D leadership and external congresses.
  • Establish biomarker studies and collaborations with academic laboratories and KOLs.

Required profile

  • Basic: doctorate in a bioscience or medical discipline with 3+ years of industry experience, or master's with 6+ years, or bachelor's with 8+ years.
  • Preferred: PhD, PharmD or MD; minimum 5 years of relevant experience, ideally in industry.
  • Experience developing program-based biomarker strategies and leading matrix-managed teams.
  • Experience in a globally dispersed team and with global programs and regulatory filings (IND/CTA/NDAs) is a plus.

Required skills

  • Strong expertise in rare disease, autoimmunity, inflammation, cell biology and genomics.
  • Biomarker assay development and qualification, clinical sample analysis, and outsourcing of assays to vendors and CROs.
  • Writing technical reports, clinical documents and biomarker publications.

What we offer

  • Expected annual salary range of $166,523.50 to $225,296.50 in the U.S., excluding Puerto Rico.
  • Health, dental and vision coverage, life and disability insurance, retirement savings plan with company contributions, and a discretionary annual bonus or sales-based incentive plan.
  • Stock-based long-term incentives, flexible work models where possible, and no application deadline.

Questions fréquentes

Le salaire proposé pour ce poste est de 167-225k USD par an. Le détail figure dans l'annonce.
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Source : ats:workday

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Published 2 days ago

Expires 1 month from now

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