Director, TMF Operations & Study Readiness

Amgen; United States; On-site; USD 180,000 - 260,000; Full time

Job summary

Amgen is seeking a Director of Study Evidence & Readiness to lead TMF Operations and Inspection Readiness, ensuring continuous, inspection-ready evidence across clinical studies. You will manage global teams, set priorities, and drive improvements in evidence health and readiness.

The role requires strong regulatory knowledge, cross-functional leadership, and experience in TMF processes, with a track record of delivering strategic, scalable solutions in a matrix environment.

Qualifications

• Doctorate or equivalent with 4 years related experience, or a Master's with 8 years, or a Bachelor's with 10 years.
• Minimum 4 years of direct managerial/leadership experience.
• Experience in TMF operations and inspection readiness.
• Knowledge of global GCP and regulatory expectations.
• Experience leading cross-functional teams in a matrix organization.

Responsibilities

• Set the strategy and priorities for TMF Operations and Inspection Readiness.
• Lead and develop global teams; set goals, manage performance, and build capability plans.
• Oversee TMF health, evidence readiness, and gaps across the study portfolio; define metrics.

Skills

Leadership

Regulatory knowledge

TMF operations

Cross-functional collaboration

Strategic planning

Education

Doctorate degree

Master's degree

Bachelor's degree

Job description

Amgen is seeking a Director of Study Evidence & Readiness to lead TMF Operations and Inspection Readiness, ensuring continuous, inspection-ready evidence across clinical studies. You will manage global teams, set priorities, and drive improvements in evidence health and readiness.

The role requires strong regulatory knowledge, cross-functional leadership, and experience in TMF processes, with a track record of delivering strategic, scalable solutions in a matrix environment.