Global Biomarker Lead
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Job Description
Leading oncology clinical biomarker strategy and execution at Amgen. Advancing biomarker-driven development of innovative medicines through clinical research and cross-functional collaboration.
Responsibilities:
- Develop and drive clinical biomarker strategies, implementation, and execution for one or more programs
- Develop clear and testable hypotheses for patient stratification/selection, pharmacodynamics, mechanism of action, and resistance evidence from clinical trial samples
- Own biomarker elements in clinical protocols, biomarker analysis plans, regulatory submissions, investigator meetings, advisory boards, and publications
- Build relationships with team members, key opinion leaders, academic institutions, and external partners
- Integrate aligned and prioritized clinical biomarker evidence plans addressing clinical objectives and translational research
- Partner with cross-functional stakeholders to drive biomarker innovation at product, disease, and modality levels
- Interpret and communicate key clinical biomarker findings and next steps to cross-functional teams, Precision Medicine teams, and leadership
Requirements:
- Doctorate degree and 3 years of industry experience in oncology clinical biomarker experience OR Master’s degree and 5 years of industry experience in oncology clinical biomarker experience OR Bachelor’s degree and 7 years of industry experience in oncology clinical biomarker experience OR Associate’s degree and 12 years of industry experience in oncology clinical biomarker experience OR High school diploma / GED and 14 years of industry experience in oncology clinical biomarker experience
- Experience developing and executing pharmacodynamic, predictive, and exploratory biomarker strategies using clinical trial samples
- Experience assessing and implementing biomarker platforms and technologies for oncology clinical programs
- Proficiency interpreting and contextualizing biomarker data and communicating findings to diverse stakeholders
- Clinical development experience working with cross-functional teams conducting clinical trials
- Experience establishing and implementing biomarker collaborations with academic laboratories/KOLs and CROs
- Proficiency in biomarker assay development and qualification, clinical sample analysis, and leading assay outsourcing processes
- Experience working effectively and leading in a team environment
- Strong written skills, including drafting technical reports, clinical protocols, clinical study reports, submission document responses, and biomarker publications
- Strong communication skills when presenting strategy, plans, and results to leadership
- Proficiency developing and executing biomarker strategies for immuno-oncology agents and/or ADCs
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
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Financial plans with opportunities to save towards retirement or other goals
- Work/life balance support
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