Amgen Technical Services Senior Manager in Thousand Oaks, California
The Technical Services Senior Manager, within Global Development Operations (GDO), is a leadership role within the Supplier Performance Management Team, with a particular emphasis on Digital Health & Innovation, Observational Research and the Patient Voice Project.
This is a dynamic industry, and as such, Amgen is currently partnering with a number of emerging technology companies to support our clinical development programs, to deliver innovative new drugs for our patients. This role is both impactful and multifaceted in scope and responsibilities, and you will have an opportunity to shape our digital health and innovative projects, as well as, ensuring that our service providers deliver effective technology solutions.
Provide leadership and technical direction for the evaluation, qualification, selection, and oversight of technical suppliers
Collaborate with Amgen Digital Health & Innovation, Observational Research, and Early Development leaders to ensure that an adequate supply of qualified suppliers is available to provide the technical and operational requirements for Amgen clinical trials.
Ensure high quality relationships (liaison) with Digital Health & Innovation, Observational Research, Patient Voice Project
Lead that support and facilitate global execution and technical service supplier results
Assist in research and assessment of new and emerging technical modalities/assays/devices/equipment/services
Participate in and lead all aspects of governance activities
Facilitate mentoring, training, and career development
Doctorate degree and 2 years of clinical experience
Master’s degree and 6 years of clinical experience
Bachelor’s degree and 8 years of clinical experience
Associate’s degree and 10 years of clinical experience
High school diploma / GED and 12 years of clinical experience
BS/BA/BSc in the sciences or RN
9+ years demonstrated ability in life sciences or medically related field, including 6+years of biopharmaceutical clinical research experience (clinical research experience acquired by working on clinical trials at a biotech, pharmaceutical, CRO or technical services supplier)
Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, medical device companies, real world data aggregation etc.)
Technologist in relevant area (e.g., imaging, laboratory, device technology) and their application to clinical trials
Work experience in monitoring, quality control and auditing practices
Device Design Review, User Acceptance Testing, Systems Development Life Cycle, Medical Device Regulation, Non-Conformance Reporting, Post Market Surveillance
Management experience of direct reports, including management level
Technical knowledge of the assigned area of focus including techniques and technologies
Knowledge of Good Clinical Practice (GCP)
FDA regulations and guidelines, including 21 CFR Part 11, ISO 13485, FDA 510(k) premarket notification, CE marking
Quality Management System processes
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives.
A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.