Precision Medicine Global Biomarker Lead
About The Position
The Precision Medicine Global Biomarker Lead is responsible for planning and executing biomarker research within oncology clinical studies. The role uses advanced technologies and methodologies to support the translation and clinical development of Amgen products. The lead develops and drives clinical biomarker strategies for one or more programs, using clinical trial samples to investigate patient stratification and selection, pharmacodynamics, mechanisms of action, and resistance. The role also leads biomarker contributions to clinical protocols, analysis plans, regulatory submissions, investigator meetings, advisory boards, and publications. The position works closely with cross-functional teams, key opinion leaders, academic institutions, external partners, vendors, and CROs to develop aligned biomarker evidence plans and advance biomarker innovation. It interprets and communicates clinical biomarker findings and recommended next steps to relevant teams and leadership.
Requirements
- One of the following education and experience combinations: doctorate degree and 3 years of industry experience in oncology clinical biomarkers; master's degree and 5 years; bachelor's degree and 7 years; associate's degree and 12 years; or high school diploma/GED and 14 years.
- Experience in oncology clinical biomarkers, as required by the applicable education and experience combination.
Nice To Haves
- Doctorate degree (PhD and/or MD) with 6 or more years of industry experience in oncology disease biology and developing biomarker strategies in a clinical development setting.
- Experience developing and executing pharmacodynamic, predictive, and exploratory biomarker strategies using clinical trial samples to elucidate mechanisms of action and characterize response and resistance.
- Experience assessing and implementing a broad range of biomarker platforms and technologies for oncology clinical programs.
- Proficiency interpreting and contextualizing biomarker data, synthesizing complex biological findings into actionable takeaways, and communicating them to scientific peers and senior leadership.
- Clinical development experience working with cross-functional teams conducting clinical trials.
- Demonstrated ability to establish and implement biomarker collaborations with academic laboratories, key opinion leaders, and CROs.
- Proficiency in biomarker assay development and qualification, clinical sample analysis, and leading biomarker assay outsourcing with external vendors and CROs.
- Experience working effectively and leading in a team environment.
- Strong writing skills, including drafting technical reports, clinical protocols and study reports, responses to submission questions, and biomarker publications.
- Strong communication skills when presenting strategies, plans, and results to leadership.
- Proficiency developing and executing biomarker strategies for immuno-oncology agents, including checkpoint inhibitors and T-cell agonists/engagers, and/or ADCs.
Responsibilities
- Develop and drive clinical biomarker strategies, implementation, and execution for one or more programs.
- Develop clear, testable hypotheses for patient stratification and selection, pharmacodynamics, mechanisms of action, and resistance using clinical trial samples.
- Lead biomarker elements in clinical protocols, biomarker analysis plans, regulatory submissions, investigator meetings, advisory boards, and publications.
- Build productive relationships with team members, key opinion leaders, academic institutions, and external partners to develop aligned and prioritized clinical biomarker evidence plans.
- Partner with cross-functional stakeholders to drive biomarker innovation at the product, disease, or modality level.
- Interpret and communicate key clinical biomarker findings and next steps to cross-functional teams, including Precision Medicine teams and leadership.
Benefits
- Health and welfare plans for staff and eligible dependents.
- Financial plans with opportunities to save toward retirement or other goals.
- Work/life balance support and career development opportunities.
- Retirement and Savings Plan with generous company contributions.
- Group medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
