Director, Local Study Operations - Flexible Work Model

BioSpace; Washington (District of Columbia); Vor Ort; USD 196.000 - 265.000; Vollzeit

Benefits dieser Stelle

Retirement plan

Stock-based incentives

Discretionary bonus program

Flexible work models where possible

Zusammenfassung

Amgen is seeking a Local Study Operations Manager (LSOM), Director, to lead the country LSOM organization and oversee the study portfolio from feasibility through close-out. You will guide LSOM Senior Managers and partners, ensure quality, timelines, budget, and regulatory compliance across the country.

You will drive cross-functional collaboration with CRAs, quality, CSPO, and vendor partners, develop capability and succession plans, and align local execution with global development priorities.

Qualifikationen

• Doctorate/Master’s/Bachelor’s as required by role.
• Strong leadership and people management skills.
• Experience in clinical research operations and vendor management.
• Deep knowledge of ICH GCP and global regulatory expectations.

Aufgaben

• Provide strategic and operational leadership for country LSOM organization.
• Direct portfolio delivery, resource strategy, and budget planning.
• Ensure compliance with regulatory standards and quality metrics across country portfolio.
• Coach LSOM Senior Managers and develop succession plans.
• Collaborate with CRA, CSPO, Quality, and FSP vendors to support trial execution.

Kenntnisse

Leadership

Strategic planning

Cross-functional collaboration

Budget management

Regulatory knowledge

Ausbildung

Doctorate degree

Masters degree

Bachelors degree

Jobbeschreibung

Amgen is seeking a Local Study Operations Manager (LSOM), Director, to lead the country LSOM organization and oversee the study portfolio from feasibility through close-out. You will guide LSOM Senior Managers and partners, ensure quality, timelines, budget, and regulatory compliance across the country.

You will drive cross-functional collaboration with CRAs, quality, CSPO, and vendor partners, develop capability and succession plans, and align local execution with global development priorities.