Precision Medicine Global Biomarker Lead

Amgen•Thousand Oaks, CA

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 and execution for one or more programs; formulates testable hypotheses for patient stratification and selection, pharmacodynamics, mechanisms of action, and treatment resistance; and oversees biomarker content in clinical protocols, analysis plans, regulatory submissions, investigator meetings, advisory boards, and publications. The role builds relationships with internal teams, key opinion leaders, academic institutions, and external partners to create aligned, prioritized biomarker evidence plans. It also partners with cross-functional stakeholders to advance biomarker innovation and communicates findings and next steps to teams and leadership.

Requirements

One of the following: 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.
Industry experience in oncology clinical biomarkers at the level corresponding to the required education.

Nice To Haves

Doctorate degree (PhD and/or MD) with 6 or more years of industry experience in oncology disease biology and development of 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 mechanisms of response and resistance.
Experience assessing and implementing a broad range of biomarker platforms and technologies for oncology clinical programs.
Proficiency in interpreting and contextualizing biomarker data, synthesizing complex biological findings into clear, actionable takeaways, and communicating them to stakeholders ranging from scientific peers to 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 assay outsourcing processes 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 strategy, plans, and results to leadership.
Demonstrated proficiency developing and executing biomarker strategies for immuno-oncology agents, such as 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, mechanism of action, and evidence of resistance using clinical-trial samples.
Own 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 integrate an aligned and prioritized clinical biomarker evidence plan.
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 for retirement or other goals.
Work/life balance and career development opportunities.
Retirement and Savings Plan with 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.