Senior Manager, In-Vitro Diagnostics/ Companion Diagnostics/ Precision Medicine Quality

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. 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.

Senior Manager, In-Vitro Diagnostics/ Companion Diagnostics/ Precision Medicine Quality

What you will do

Let’s do this! Let’s change the world! In this remote role you will report to the Director of Precision Medicine and Diagnostics within R&D Quality. This role supports the use of

In-Vitro Diagnostics (IVD), including Companion Diagnostics (CDx), within Amgen’s global clinical trials. This role is responsible for supporting the implementation of a proactive and risk-based Quality strategy for IVD medical devices, including collaborations with diagnostic partners (testing laboratories).

The Precision Medicine and Diagnostic Quality strategy is focused on all aspects of research and development at Amgen, spanning from discovery through the entire lifecycle of clinical development.

Responsibilities

• Support quality oversight of IVD medical devices used within Amgen’s precision medicine and digital medicine clinical trials.

• Provide subject matter expertise on the regulatory and quality oversight of

• IVDs, including CDx, Laboratory Developed Test (LDTs), assays, within the areas of precision and digital medicine.

• Collaborate with Amgen’s IVD and diagnostic partners to ensure quality oversight of IVDs/ assays used within Amgen drug clinical trials to ensure industry standard processes and all regulations are followed.

• Supports the IVD/ CDx team and collaborators to ensure that IVD/ CDx quality management strategies are advanced related to the evolving and complex IVD regulatory landscape, including the EU and US.

• Provide support for Quality Agreements, clinical trial protocol review, Informed Consent form reviews, IRB application review.

• Provide support for EU Clinical Performance Studies and US IDE requirement implementation.

• Understands and …