Principal Scientist - Inflammation Biomarkers

Role Summary

Principal Scientist - Inflammation Biomarkers. In this role you will drive scientific and technical plans within the Precision Medicine function, partnering across Amgen research and development to advance clinical biomarker innovation for inflammatory diseases. You will apply biomarker expertise to support clinical-stage assets and collaborate with cross-functional teams to deliver translational biomarker evidence that informs patient stratification, pharmacodynamics, and mechanism of action.

Responsibilities

• Preparing clinical biomarker strategies, leading biomarker development, implementation, and execution for one or more programs
• Responsible for biomarker elements in clinical protocols, biomarker analysis plans, regulatory submissions, investigator meetings, advisory boards and publications
• Build productive relationships with team members and functional groups to integrate an aligned clinical biomarker evidence plan that addresses clinical objectives and translational research
• Partner with cross-functional stakeholders to drive biomarker innovation at the product level
• Establish and implement biomarker studies and collaborations with academic laboratories/KOLs
• Interpret and communicate key clinical biomarker findings to cross-functional teams including Precision Medicine teams and leadership
• Deliver robust clinical biomarker plans to support patient stratification/selection, pharmacodynamics, mechanism of action and resistance evidence from clinical trial samples

Qualifications

• Required: Doctorate degree in a bioscience or medical discipline and 2 years of industry experience
• Required: Master’s degree in a bioscience or medical discipline and 4 years of industry experience
• Required: Bachelor’s degree in a bioscience or medical discipline and 6 years of industry experience
• Required: Associate’s degree in a bioscience or medical discipline and 10 years of industry experience
• Required: High school diploma / GED and 12 years of directly related industry experience
• Preferred: PhD with 3 or more years pharmaceutical industry experience, developing biomarker strategies in a clinical development setting and/or in preclinical biomarker discovery/validation
• Preferred: Knowledge and translational biomarker experience in inflammation
• Preferred: Strong background in immunology, cell biology and genomics
• Preferred: Clinical development experience working with cross-functional teams conducting clinical trials
• Preferred: Experience developing program-based strategies for pharmacodynamic, predictive, and exploratory biomarkers
• Preferred: Experience implementing a broad array of biomarker platforms and technologies to support clinical-stage programs
• Preferred: Demonstrated ability to establish and implement biomarker studies and collaborations with academic laboratories/KOLs
• Preferred: Experience in assay development and qualification and analysis of clinical samples
• Preferred: Experience managing biomarker assay outsourcing processes with external vendors and CROs
• Preferred: Professionalism with strong communication and influencing skills in a dynamic environment

Education

• Doctorate, Master’s, Bachelor’s, Associate’s, or High School Diploma with relevant industry experience (as listed under Required)