Sr. Principal Scientist- Global Biomarker Lead, Oncology Clinical Biomarkers

Amgen • Washington, DC

236d • Hybrid

About The Position

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Requirements

• Doctorate degree and 2 years of industry experience in oncology clinical biomarker experience OR Master's degree and 4 years of industry experience OR Bachelor's degree and 6 years of industry experience OR Associate's degree and 10 years of industry experience OR High school diploma / GED and 12 years of industry experience.

Nice To Haves

• Doctorate degree (PhD and/or MD) with 4+ years industry experience in oncology disease biology and developing biomarker strategies in a clinical development setting.
• Experience driving pharmacodynamic, predictive and exploratory biomarkers such as mechanisms of resistance studies with clinical trial samples.
• Experience assessing and 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 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.
• Experience working effectively and leading in a team environment.
• Strong written skills with experience drafting technical reports and biomarker publications.
• Effective communication skills when presenting strategy, plans and results to leadership.

Responsibilities

• Plan and execute biomarker research within oncology clinical studies.
• 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.
• Responsible for 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.
• Partner with cross functional stakeholders to drive biomarker innovation at the product level as well as 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

• 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, and flexible spending accounts.
• A discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree