Principal Scientist - Global Diagnostics Development Lead (US-REMOTE)

Career Category

Scientific

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Principal Scientist - Global Diagnostics Development Lead

Live

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 and will work out at our Thousand Oaks or South San Francisco research sites. Remote employment will be considered for well qualified candidates.

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 in order 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 development life cycle management plans that align to the needs of their corresponding precision therapeutics programs with a focus on the Oncology therapeutic area. 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 diagnostic development strategies to support therapeutic product teams
• The development and successful implementation of global strategic diagnostic development life cycle plans, programs and initiatives to support approval and commercialization of diagnostics which will support the therapeutic life cycles
• Lead efforts to oversee assay development and assay transfer to CROs with diagnostic partners
• Support diagnostic development options and technologies and diagnostic market landscape assessment
• Working with key cross-functional partners to implement diagnostic development, approval and launch strategies for the product teams together with third-party diagnostic partners and ensuring successful implementation of the overall Dx strategy globally

Win

What we expect of you

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

Basic Qualifications:

Doctorate degree and 3 years of pharmaceutical and/or diagnostics experience

Or

Master’s degree and 6 years of pharmaceutical and/or diagnostics experience

Or

Bachelor’s degree and 8 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 planning / reviewing resource allocation, complex timeline development, risk identification / mitigation

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $150,896 - $175,983.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• 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, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.

Salary Range

150,896.00 USD - 175,983.00 USD