Director, Companion Diagnostics Development Strategy Lead, CDx

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.

Director, Companion Diagnostics Development Strategy Lead, CDxLive

What you will do

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 work out at our Thousand Oaks or South San Francisco research sites.

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 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 within the Oncology therapeutic area. The Diagnostic Strategy Lead role will be a critical strategic role at Amgen requiring a breadth of technical and business communication expertise across a broad range of partners, influencing decision-making through negotiation, and addressing conflict by building productive working relationships across functional areas both within and outside the company.

The primary responsibility of the successful candidate will be to develop comprehensive Dx strategies for China and to assure that those programs are fully aligned with global Dx strategy. This individual will also support the development of global Dx strategies across the Oncology portfolio.

Responsibilities:

• The endtoend diagnostic development strategies to support therapeutic product teams within the Oncology therapeutic area.

• 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

• Developing cases, driving the strategic evaluation of diagnostic development options and technologies, diagnostic market landscape assessment

• Working with key cross-functional partners to integrate diagnostic development, approval and launch strategies for the product teams together with third-party diagnostic partners and ensuring successful execution of the overall Dx strategy globally

• Ensuring that the diagnostic strategy incorporates global requirements for execution and success

• Working closely with global and regional marketing teams, and other cross functional partners and collaborators, to deliver and implement diagnostic business strategies globally

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of pharmaceutical and/or diagnostics experience

Or

Masters degree and 8 years of pharmaceutical and/or diagnostics experience

Or

Bachelors degree and 10 years of pharmaceutical and/or diagnostics experience

And

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Proven experience developing critical initiatives and gaining stakeholder alignment at all levels in the organization

• Highly effective presentation / 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

• Knowledge and experience in clinical trial design

• 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.

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.