Amgen Director of Imaging - Clinical Biomarkers & Diagnostics in Thousand Oaks, California
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. Join us.
Director of Imaging - Clinical Biomarkers & Diagnostics
The Clinical Biomarker and Diagnostics (CBD) Dept of Amgen is actively recruiting for a Strategic Lead to lead the development and implementation of impactful biomarker-driven clinical imaging strategies to support our portfolio of innovative drug candidates. The candidate will be expected to work cross-functionally with other functions to provide our project teams with imaging-based strategies as solutions to clinical questions ranging from biochemical coverage & pharmacodynamics to patient selection/stratification methodologies & CDx implementation. There will be an emphasis on our Oncology portfolio, though Imaging strategies are used in all our therapeutic areas.
What you will do
Let’s do this. Let’s change the world. In this vital role you will be a Subject matter expert (SME) and strategic leader within the CBD Dept for Clinical Imaging for biomarker and CDx activities within our clinical portfolio.
Actively develop and coordinate Amgen’s relationships with external imaging guides, leading consortia & regulatory bodies and build and maintain network with academic institutions/diagnostic companies/imaging companies including CROs in Oncology
Responsible for advising development teams on appropriate use of imaging biomarkers and techniques and on the appropriate implementation in clinical trials (imaging acquisition and analysis techniques, imaging documents including charters, image collection, quality control and archiving)
Partner with research teams in the development of imaging-based biomarker/CDx methodologies for early candidate programs. Provide leadership translating these strategies into feasible clinical assays that takes into consideration the appropriate ‘fit-for-purpose’ level.
Work with Study Ops, Finance and Global Strategic Sourcing to guide the identification, selection and implementation processes of imaging CROs, optimal test sites, etc.
Partner with our Service Provider Management division to develop and monitor QC metrics for our CROs
Integrate the output generated by imaging providers and analysis groups to provide clinical teams with the appropriate analyses of generated data.
Ensure regulatory compliance of imaging activities and drives qualification processes.
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 go-getter with these qualifications.
Doctorate degree with 6+ years of scientific experience
Master’s degree and 8 years of scientific experience
Bachelor’s degree and 10 years of scientific experience
M.D. or Ph.D. with imaging training in radiology, nuclear medicine, imaging physics or image analysis with at least two years of industry experience, or a Masters’ degree with training in radiology, nuclear medicine, imaging physics or image analysis including at least four years of industry experience.
Consistent record of research and/or clinical development (including oncology applications with emphasis on radiological and /or PET/SPECT imaging and biomarker use);
Thorough understanding of imaging and clinical development in oncology, including experience with regulatory framework for biomarkers, and use of imaging for registration of Oncology products;
Understanding of novel ligand development from bench to clinic will be preferred
Experience with modern clinical trial design, and analytic methodologies for imaging endpoints.
Experience interacting with imaging CROs;
Outstanding scientific reputation as evidenced by multiple publications in peer reviewed journals and as speaker of conferences;
Strong interpersonal; skills with demonstrated ability to develop and communicate a strategic vision to various partners across a broad organization.
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.
Equal Opportunity Statement
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 a 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 an 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.
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.