Study Oversight Senior Manager

About the role

Join Amgen’s mission of serving patients. At Amgen, you’ll be part of a shared mission—to serve patients living with serious illnesses. Our focus spans four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—reaching millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on patients' lives through research, manufacturing, and delivering innovative medicines.

This role is accountable for managing all FSP resources (CRA, CTA, LSOM) to ensure quality, efficiency, and adherence to compliance standards. You will also serve as the secondary contact and escalation point for all FSP supplier-related concerns within the country.

Responsibilities

• Mentor, train, and support the professional development of SOM Mgrs
• Serve as the point of contact for FSP supplier(s) resource and capacity management, portfolio planning, and prioritization from study startup to close-out at the country level
• Ensure oversight of supplier performance (e.g., tracking against metrics, assuring overall quality of work performed by FSP staff)
• Identify, escalate, and resolve quality and trial delivery issues
• Collaborate with LSOMs Sn Mgs and/or LSOM AD to ensure appropriate level of staff oversight, maintaining quality throughout Amgen clinical trials (e.g., occasional on-site quality visits)
• Ensure effective collaboration between SOM Mgrs, driving consistent communication with FSPs, sites, and alignment with global strategies
• Escalate issues to the County-Hub Head GSSO
• Aggregate and communicate country-wide issues through consolidating input from FSPs to provide a country-aggregated view on FSP trends and challenges to senior management
• Oversee management of FSP supplier performance covering study milestones achievement and quality targets
• Support inspection readiness
• Support local country site-level audits and regulatory inspections when applicable
• Support maintenance of Amgen investigator site relationships in country
• Participate in cross-functional task force/process improvement groups

Requirements

We seek candidates with the following qualifications:

• Doctorate degree and 2 years of clinical execution experience, OR
• Master’s degree and 6 years of clinical execution experience, OR
• Bachelor’s degree and 8 years of clinical execution experience, OR
• Associate’s degree and 10 years of clinical execution experience, OR
• High school diploma/GED and 12 years of clinical execution experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience.

Preferred Qualifications

• 7 years of work experience in life sciences or a medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical, or CRO company
• Experience managing multiple teams/direct reports across multiple clinical functions/trials
• Experience at, or oversight of, clinical research suppliers (CROs, central labs, imaging suppliers, etc.)
• Experience managing clinical operations across relevant geography/region, including a strong understanding of local regulatory requirements around global clinical trials

Benefits

Amgen offers a Total Rewards Plan, based on eligibility, that includes:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements where possible

Pay

The annual base salary range for this opportunity in the U.S. is $167,187–$226,194.