Precision Medicine Global Biomarker Lead , Rare Disease

Career Category

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 - Rare Disease

What you will do

Let’s do this. Let’s change the world. In this vital role within the Precision Medicine Unit, the Global Biomarker lead will serve as a key member of Amgen’s cross-functional product teams, driving biomarker strategies that align with Precision Medicine goals.

We are seeking a highly motivated and experienced senior principal scientist with expertise in clinical biomarker research and drug development in rare diseases and/or autoimmunity and inflammation to develop and execute scientifically robust precision medicine strategies that are integrated with global development strategies.  The successful candidate will also oversee assay readiness, vendor management, and interpretation of biomarker data generation, while partnering closely with clinical development, research, and medical affairs colleagues.

Key Responsibilities:

• Lead the development and execution of robust program-specific clinical biomarker strategies to inform target engagement, pharmacodynamics, mechanism of action, and patient selection across early and late stage programs
• Serve as precision medicine subject matter expert within product evidence generation teams to deliver precision medicine and translational medicine approaches to enable strategic alignment and delivery of high-quality biomarker datasets
• Responsible for biomarker elements in clinical protocols, biomarker analysis plans, regulatory submissions, investigator meetings, advisory boards and publications
• Lead and partner with biomarker technical sub-teams to plan all components of clinical biomarker strategy implementation including specialty vendor evaluations, biomarker budget and contract planning, biomarker and pharmacodynamic sample operations, biomarker data analysis plans, and cross-functional data sharing.
• Interpret and communicate key clinical biomarker findings in an impactful way to cross functional and non-technical stakeholders, including Precision Medicine teams, product teams, R&D leadership, external scientific congresses, and lay audiences.
• Establish and implement biomarker studies and collaborations with academic laboratories/KOLs

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 in a bioscience or medical discipline and 3+ years of industry experience Or

Master’s degree in a bioscience or medical discipline and 6+ years of industry experience Or

Bachelor’s degree in a bioscience or medical discipline and 8+ years of industry experience  

Preferred Qualifications:

• PhD in a relevant field; PharmD, MD, or equivalent considered. Minimum 5+ years of relevant experience, ideally in industry
• Experience in developing program-based clinical biomarker strategies and its execution while supporting cross-functional clinical study teams
• Strong expertise in rare disease, autoimmunity, inflammation, cell biology, and genomics
• Strong written and verbal communication skills with experience drafting technical reports, clinical documents, and biomarker publications, and interpreting and communicating biomarker results to cross-functional teams and R&D leadership
• Experience implementing a broad array of biomarker platforms and technologies including biomarker assay development and qualification, analysis of clinical samples, and managing biomarker assay outsourcing processes with external