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.

BASIC QUALIFICATIONS:

Doctorate degree and 2 years of pharmaceutical and/or diagnostics experience
OR
Master’s degree and 4 years of pharmaceutical and/or diagnostics experience
OR
Bachelor’s degree and 6 years of pharmaceutical and/or diagnostics experience
OR
Associate’s degree and 10 years of pharmaceutical and/or diagnostics experience
OR
High school diploma / GED and 12 years of pharmaceutical and/or diagnostics experience

PREFERRED QUALIFICATIONS:

• Effective presentation and communication skills at the senior/executive management level
• Experience in oncology precision medicine development and / or in vitro diagnostics development
• Experience in companion diagnostics development and knowledge of regulatory submission requirements of in vitro diagnostic devices in multiple markets preferred
• Knowledge and experience in clinical trial design preferred
• Experience integrating data from multiple sources and identifying critical process variables
• Experience establishing and reviewing complex plans for multiple projects or activities. This includes resource allocation, complex timeline development, risk identification and mitigation
• Experience in digital pathology is a plus

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this vital role you will be responsible for the development and implementation of Diagnostic (Dx) development strategies globally.
Integral to the ongoing success of Amgen’s growing pipeline, the Diagnostics (Dx) Group is responsible for the successful transition of a biomarker assay to marketed Diagnostic to support the clinical development strategy for regulatory approval and commercialization.
As such, the Dx group works closely with other functions within Amgen to identify the appropriate partners for diagnostic test development. We are looking for individuals with experience in driving end-to-end diagnostic development strategies and developing life cycle management plans that align to the needs of their corresponding precision therapeutics programs. The Diagnostic Development Lead role at Amgen requires a breadth of technical expertise across a broad range of in-vitro diagnostic technologies, influencing decision-making through negotiation, and addressing conflict by building productive working relationships across functional areas both within and outside the company.
This position will report to a Global Diagnostics Strategy Director and be responsible for the successful implementation of the CDx strategy across multiple therapeutic areas with a focus on oncology.

RESPONSIBILITIES:

• Execute end–to–end global diagnostic development strategies to support therapeutic product teams, including regulatory approval, commercialization, and diagnostic lifecycle plans
• Lead efforts to oversee assay development and assay transfer to CROs with diagnostic partners
• Support diagnostic development options, technologies, and diagnostic market landscape assessment
• Work with key cross-functional partners to implement diagnostic development, approval and launch strategies for the product teams together with third-party diagnostic partners and ensure successful implementation of the overall Dx strategy globally