#WeareBiotech
Global Biomarker Lead, Rare Disease
Location
United States
Posted
4 days ago
Salary
$166.5K - $225.3K / year
Seniority
Senior
Job Description
Global Biomarker Lead, Rare Disease
Amgen
• 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
Job Requirements
- 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.
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.
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