Clinical Biomarkers and Diagnostics Operations Lead
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Title: Clinical Biomarkers and Diagnostics Operations LeadLive
What you will do
Lets do this. Lets change the world. In this vital role you will as below:Essential Duties and Job Functions:
- Drives the implementation of the clinical biomarker and diagnostic plans for therapeutic programs in early and late stage clinical development across therapeutic areas.
- Accountable for the development of a project and/or clinical study biomarker and diagnostics biosamples strategy.
- Accountable to ensure the logistical feasibility of a project and/or clinical study biomarker and diagnostics biosamples strategy, considering appropriate logistical options and costs.
- Serves as first point of contact for biomarker and diagnostics biosamples operational questions within a project(s) and coordinates with other functions within and outside of the company (e.g., Bio-Sample Management, Clinical Operations, Biomarker and Diagnostic Leads).
- Develops a sample reconciliation plan for each sample type including data management for relevant data collection and reporting within studies while also ensuring consistency of reconciliation activities within project(s).
- Reviews study protocols and sample collection ICFs prior to finalization and provides input to ensure the protocol and ICFs enable sample testing according to the Biomarker and Diagnostics plans.
- Project owns the implementation of clinical trial assays at reference labs and centralized testing vendors, ensures delivery of assay/ data results and is a key contact for the assay lab.
- Project leads contracts, budgets and time-lines for biomarker activities within studies to ensure timely completion of biomarker and diagnostic activities.
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.Basic Qualifications
- Life Sciences degree (higher qualification e.g. MSc or equivalent preferred).
- Further qualification, e.g. project management certification is desirable.
- 4+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
- Extensive clinical development experience of working in teams running clinical studies
- Clinical or biological laboratory experience with involvement in the processing and/or analysis of biological samples
- Project management skills and knowledge of project management tools
- Critical reasoning skills including the identification and resolution of complex problems
- Detail oriented with the ability to work independently and lead multiple challenging priorities
Some of the vast rewards of working here
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.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor.
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual 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.
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.Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.