Principal Scientist -Translational Medicine / Companion Diagnostics (US-Remote)
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. Join us.
Principal Scientist - In Vitro DiagnosticsLive
What you will do
Lets do this. Lets change the world. Amgen is seeking a Principal Scientist - In Vitro Diagnostics to work out of our Thousand Oaks, CA or South San Francisco, CA research sites.
Integral to the ongoing success of Amgens comprehensive biomarker programs, the Medical Sciences In Vitro Diagnostics (IVD) Group is responsible for the transition of exploratory biomarkers to marketed IVDs, working with other functions within Amgen to identify the appropriate partner for diagnostic test development. In this vital role you will use a wide breadth of communication expertise across a broad range of stakeholders, influencing decision-making through negotiation, and addressing conflict by building productive working relationships across functional areas both within and outside the company.Position Responsibilities
- Formulate and implement companion diagnostic development strategies through integration of functional stakeholder input
- Work with third party companion diagnostic partners to develop project plans including resource identification, budget, facility and regulatory requirements to meet project goals and clinical timelines
- Lead internal and external cross-functional teams required to manage and execute external diagnostic development partnerships with third parties from inception through regulatory approval in multiple jurisdictions
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 Scientist with these qualifications.Basic Qualifications
Doctorate degree and 3 years of companion diagnostic development experienceOr
Masters degree and 6 years of companion diagnostic development experienceOr
Bachelors degree and 8 years of companion diagnostic development experiencePreferred Qualifications
- Ph.D in Molecular Biology, Cell Biology, Immunology or Genomics
- Subject matter expert with proven pharma-facing experience developing and launching companion diagnostics in alignment with drug development programs
- Poise and professionalism with strong communication and influencing skills in a dynamic and changing environment
- R&D experience in companion diagnostics development and knowledge of regulatory submission requirements of in vitro diagnostic devices in multiple markets
- 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 resource allocation and distribution and identifying risks and contingency plans
- Understanding of clinical study design and operational considerations associated with the alignment of companion diagnostic and pharmaceutical clinical trials
- 5+ years of experience in pharmaceutical industry
What you can expect of us
As we work to develop treatments that take care of others, so we 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
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.
Join UsIf 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 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.