Sr Principal Scientist/Global Biomarker Lead Oncology Clinical Biomarkers

Amgen - Washington, DC

Full-time - Senior

Hybrid - Washington, DC

10,001+ employees

Chemical Manufacturing

About the position

The Senior Principal Scientist/Global Biomarker Lead at Amgen is a pivotal role focused on planning and executing biomarker research within oncology clinical studies. This position involves collaborating with cross-functional teams to drive clinical biomarker innovation, ensuring the successful development and implementation of biomarker strategies that enhance patient stratification and understanding of drug mechanisms.

Responsibilities

• Prepare clinical biomarker strategies for oncology clinical assets.
• Lead biomarker development, implementation, and execution for multiple programs.
• Develop robust clinical biomarker plans to deliver patient stratification, pharmacodynamics, and mechanism of action evidence from clinical trial samples.
• Oversee biomarker elements in clinical protocols, analysis plans, regulatory submissions, and publications.
• Build relationships with team members and functional groups to align clinical biomarker evidence plans with clinical objectives.
• Partner with cross-functional stakeholders to drive biomarker innovation at the product level.
• Interpret and communicate key clinical biomarker findings to cross-functional teams and leadership.

Requirements

• Doctorate degree and 2 years of industry experience in oncology clinical biomarker development, or
• Masters degree and 4 years of industry experience in oncology clinical biomarker development, or
• Bachelors degree and 6 years of industry experience in oncology clinical biomarker development, or
• Associates degree and 10 years of industry experience in oncology clinical biomarker development, or
• High school diploma / GED and 12 years of industry experience in oncology clinical biomarker development.

Nice-to-haves

• Doctorate degree (PhD and/or MD) with 5+ years industry experience developing oncology biomarker strategies in a clinical development setting.
• Experience developing and executing pharmacodynamic, predictive, and exploratory biomarkers with clinical trial samples.
• Experience implementing a broad array of biomarker platforms and technologies to support oncology clinical programs.
• Clinical development experience working with cross-functional teams conducting clinical trials.
• Demonstrated ability to establish and implement biomarker studies and collaborations with academic laboratories/KOLs and CROs.
• Knowledge of biomarker assay development and qualification, analysis of clinical samples, and leading biomarker assay outsourcing processes with external vendors and CROs.
• Strong written and verbal communication skills with experience drafting technical reports and publications.

Benefits

• Comprehensive employee benefits package including health and welfare plans.
• 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 sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models including remote and hybrid work arrangements.