Director of TMF Strategy & Inspection Readiness

Amgen; Washington (District of Columbia); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Discretionary annual bonus program

Flexible work models

Benefits package including health/well

Job summary

Amgen seeks a Director of Study Evidence & Readiness to lead TMF Operations and Inspection Readiness across global clinical studies. You will ensure evidence is complete, retrievable, and inspection-ready, guiding strategy and cross-functional execution.

You will manage senior managers and build capability, align metrics, and drive improvement initiatives while partnering with stakeholders to meet portfolio needs and regulatory expectations.

Qualifications

• Doctorate or equivalent with extensive leadership experience in life sciences.
• Experience leading TMF operations and inspection readiness in global studies.
• Strong understanding of global GCP and regulatory expectations.

Responsibilities

• Set strategy for TMF Operations and Inspection Readiness.
• Lead and develop global teams; manage performance and succession.
• Oversee TMF health, evidence gaps, and inspection readiness across study portfolio.
• Plan department structure, budget, resources, and continuity.

Skills

Leadership experience

Cross-functional collaboration

Regulatory knowledge

Strategic planning

People management

Education

PhD

PharmD

MSc

BSc

RN qualification

Tools

TMF systems

Regulatory databases

Job description

Amgen seeks a Director of Study Evidence & Readiness to lead TMF Operations and Inspection Readiness across global clinical studies. You will ensure evidence is complete, retrievable, and inspection-ready, guiding strategy and cross-functional execution.

You will manage senior managers and build capability, align metrics, and drive improvement initiatives while partnering with stakeholders to meet portfolio needs and regulatory expectations.