Precision Medicine Global Biomarker Lead

Career Category

Finance

Job Description

Join Amgen’s Mission of Serving Patients

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Precision Medicine Global Biomarker Lead - Oncology Clinical Biomarkers

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for planning and executing biomarker research within oncology clinical studies. Your work, using advanced technologies and methodologies, will help in the translation and clinical development of the company's products. Main duties and responsibilities include:

• 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 to deepen the understanding of disease treatment approaches and for critical decision making
• 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 for integrating an aligned and prioritized clinical biomarker evidence plan that addresses clinical objectives and/or translational research
• Partner with cross functional stakeholders to drive biomarker innovation at the product level as well as disease or modality level
• Interprets and communicates key clinical biomarker findings as well as next steps to cross functional teams including Precision Medicine teams and leadership

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

• Doctorate degree and 3 years of industry experience in oncology clinical biomarker experience

OR

• Master’s degree and 5 years of industry experience in oncology clinical biomarker experience

OR

• Bachelor’s degree and 7 years of industry experience in oncology clinical biomarker experience

OR

• Associate’s degree and 12 years of industry experience in oncology clinical biomarker experience

OR

• High school diploma / GED and 14 years of industry experience in oncology clinical biomarker experience

Preferred Qualifications:

• Doctorate degree (PhD and/or MD) with 6+ years industry experience in oncology disease biology and developing biomarker strategies in a clinical development setting
• Demonstrated 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 array of biomarker platforms and technologies to support oncology clinical programs
• Proficiency in interpreting and contextualizing biomarker data, synthesizing complex biological findings into clear, actionable takeaways, and communicating them effectively to diverse stakeholders, 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/KOLs and CROs
• Demonstrated proficiency in 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 proficiency in drafting; technical reports, clinical protocol and clinical study reports, submission document response to questions, biomarker publications
• Strong communication skills when presenting strategy, plans and results to leadership
• Demonstrated proficiency in developing and executing biomarker strategies for immuno-oncology agents (checkpoint inhibitors, T-cell agonists/engagers) and/or ADCs

What you can expect of us

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