Director, Local Study Operations — Clinical Trials

Amgen Inc.; United States; Hybrid; USD 196,000 - 265,000; Full time

Benefits offered by this job

Health and welfare plans

Retirement and savings plan

Stock-based incentives

Excellent time-off programs

Flexible work models

Job summary

Amgen seeks a Local Study Operations Manager (LSOM), Director, to provide strategic and operational leadership for the country LSOM organization. You will ensure quality, timeliness, cost control, and compliant execution of the country clinical study portfolio, guiding LSOM Senior Managers, FSP and FTE teams, and interfacing with global and regional governance.

You will translate global development strategy into country priorities, manage resource and capacity planning, and drive improvements in

Qualifications

• Advanced leadership experience in clinical study operations and portfolio delivery.
• Strong knowledge of ICH GCP, regulatory expectations, and risk-based monitoring.
• Experience coordinating large, multi-team responsibilities across country programs.

Responsibilities

• Lead LSOM Senior Managers and teams (FSP and FTE) to deliver country study portfolio.
• Provide strategic direction across feasibility, execution, and close-out of trials.
• Ensure quality, timelines, budgets, and compliance for LSOM operations.
• Manage vendor performance and escalation of critical issues.
• Develop leadership capability and succession planning within LSOM.
• Establish partnerships with CRA teams to support start-up, monitoring, and execution.
• Drive operational excellence and continuous improvement across country operations.
• Align study strategy with local execution and cross-functional partnerships.
• Oversee resource strategy, capacity planning, and workload allocation.

Skills

Leadership

Cross-functional collaboration

Project management

Risk management

Vendor management

Education

Doctorate degree + 4 yrs clinical research

Master’s degree + 7 yrs clinical research

Bachelor’s degree + 9 yrs clinical research

Job description

Amgen seeks a Local Study Operations Manager (LSOM), Director, to provide strategic and operational leadership for the country LSOM organization. You will ensure quality, timeliness, cost control, and compliant execution of the country clinical study portfolio, guiding LSOM Senior Managers, FSP and FTE teams, and interfacing with global and regional governance.

You will translate global development strategy into country priorities, manage resource and capacity planning, and drive improvements in