Join Amgen’s Mission of Serving Patients
Position: Local Study Operations Line Manager
What you will do
-
Ensure the successful delivery of the study portfolio assigned to LSOMs.
-
Oversee LSOMs’ fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to study close-out.
-
Monitor portfolio progress, provide risk and quality oversight, and support issue escalation and resolution for LSOMs.
-
Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country.
-
Mentor, train, and support the professional development of LSOMs to prepare them for managing complex trials.
-
Build and maintain a high-performing team.
-
Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio.
-
Promote cross-functional collaboration among country teams to ensure successful delivery of the country portfolio.
-
Support discussions regarding study placement decisions based on country capabilities and growth potential.
-
Proactively evaluate risks, quality trends, and resource requirements; implement mitigation strategies and drive continuous improvement in country operations.
-
Lead initiatives to enhance operational efficiency and encourage sharing of best practices.
-
Manage resource allocation and workload distribution across LSOMs, including both FSP and FTE personnel, to optimize trial execution and align with global priorities.
-
Ensure adherence to regulatory and quality standards where applicable.
-
Collaborate with and support the country head in engaging cross-functional stakeholders, aligning on trial deliverables, and managing escalations.
What we expect of you
Basic Qualifications:
-
Doctorate degree & 2 years of clinical execution experience OR
-
Master’s degree & 6 years of clinical execution experience OR
-
Bachelor’s degree & 8 years of clinical execution experience OR
-
Associate’s degree & 10 years of clinical execution experience OR
-
High school diploma / GED & 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 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 referenced above
Preferred Qualifications:
-
7 years work experience in life sciences or 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 vendors (CRO’s, central labs, imaging vendors, etc.)
-
Experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials
What you can expect of us
-
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
careers.amgen.com
