HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Principal Scientist - Global Diagnostics Development LeadLive
What you will do
Lets do this. Lets change the world. Lets do this. Lets change the world.
In this vital role you will be responsible for the development and implementation of Diagnostic (Dx) development strategies globally and will be based in our Thousand Oaks or South San Francisco sites. Remote employment will be considered for well qualified candidates.
Integral to the ongoing success of Amgens 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.
- Implement endtoend 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 ensuring successful implementation of the overall Dx strategy globally
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.
Doctorate degree and 3 years of pharmaceutical and/or diagnostics experience
Masters degree and 6 years of pharmaceutical and/or diagnostics experience
Bachelors degree and 8 years of pharmaceutical and/or diagnostics experience
Associates degree and 10 years of pharmaceutical and/or diagnostics experience
High school diploma / GED and 12 years of pharmaceutical and/or diagnostics experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resourcesPreferred Qualifications:
- Effective presentation and communication skills at the senior/executive management level
- Experience in oncology precision medicine development and / or in vitro diagnostics
- 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
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.
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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.