Strategic Director, Local Study Operations

Amgen; United States; Remote; USD 196,000 - 265,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Group medical/dental/vision insurance

Life and disability insurance

Flexible spending accounts

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen is seeking a Local Study Operations Manager, Director, to lead the country LSOM organization. You will oversee the portfolio from feasibility to close-out, manage resources, budgets, quality and risk, and drive improvements with cross-functional teams.

You will partner with CRA and regional teams to ensure compliant trial execution, support inspections, and build leadership within the LSOM team. A doctoral or equivalent clinical research background is required, with strong PM and

Qualifications

• Doctorate or Master’s or Bachelor’s with required clinical research experience.
• 4 years of direct managerial and/or leadership experience.
• Deep knowledge of ICH GCP, ICH E6(R3), ICH E8(R1) and global regulatory expectations.
• Ability to influence senior stakeholders and lead cross-functional initiatives within a global matrix organization.
• Strong Project Management experience.
• Experience managing clinical operations across relevant geography/region and vendors.
• Experience managing clinical research vendors (CROs, labs, imaging, etc.).

Responsibilities

• Lead LSOM Senior Managers and teams to deliver country study portfolio.
• Ensure inspection readiness and support during inspections.
• Drive continuous operational improvements and best practices.
• Collaborate with cross-functional stakeholders to align on trial deliverables.
• Sponsor capability building and succession planning.

Skills

Leadership experience

Project management

Cross-functional collaboration

Vendor management

ICH GCP knowledge

Education

Doctorate degree

Master's degree

Bachelor's degree

Job description

Amgen is seeking a Local Study Operations Manager, Director, to lead the country LSOM organization. You will oversee the portfolio from feasibility to close-out, manage resources, budgets, quality and risk, and drive improvements with cross-functional teams.

You will partner with CRA and regional teams to ensure compliant trial execution, support inspections, and build leadership within the LSOM team. A doctoral or equivalent clinical research background is required, with strong PM and