Career Category

Job Description

The Supplier Performance Management Senior Manager, within Global Development Operations (GDO), is a leadership role within the Supplier Performance Management Team, with a particular emphasis on digital health technologies and Decentralized Clinical Trials (DCT).

This is a dynamic industry, and as such, Amgen is currently partnering with a number of emerging technology & DCT 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 technologies projects and DCT, as well as, ensuring that our suppliers deliver effective services and technology solutions.

Responsibilities:

• Provide leadership and technical direction for the evaluation, qualification, selection and oversight of clinical trial technical suppliers.
• Collaborate with internal Amgen Organizations such as Digital Health & Innovation, Digital Medicine Therapeutic Areas leads, Global Development Operations 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 internal Amgen Organizations such as Digital Health & Innovation, Digital Medicine and Global Development Operations teams
• Collaborate with study and site management teams on operational implementation of digital or DCT solutions
• Lead supplier functional management team governance activities
• Lead that supports clinical study team and facilitates global execution of technical service supplier services for clinical trials
• Assist in research and assessment of new and emerging technical modalities/assays/devices/equipment/services for use in clinical trials
• Participate in and lead all aspects of governance activities
• Facilitate mentoring, training, and career development

Basic Qualifications:

Doctorate degree and 2 years of clinical experience

OR

Master’s degree and 6 years of clinical experience

OR

Bachelor’s degree and 8 years of clinical experience

OR

Associate’s degree and 10 years of clinical experience

OR

High school diploma / GED and 12 years of clinical experience

Preferred Qualifications:

• 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, DCT service providers, 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

Knowledge:

• Familiarity with clinical trial execution
• Familiarity with Supplier Management
• 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