Director, Study Evidence & Readiness

Overview

In this role, you will lead Amgen’s global Study Evidence & Readiness function, shaping the strategy for TMF Operations and Inspection Readiness. You’ll ensure complete, high-quality evidence across studies to support regulatory compliance and inspection readiness. You’ll develop and lead global teams, drive process improvements, and collaborate with cross‑functional partners to resolve evidence issues. This is a chance to influence regulatory readiness at scale and contribute to Amgen’s patient-focused mission.

Pay / Benefits

• competitive benefits
• Total Rewards Plans
• remote work

Responsibilities

• Define and execute strategy for TMF Operations and Inspection Readiness aligned with portfolio priorities and regulatory requirements
• Lead and develop global teams, driving performance, talent development, succession planning, and operational excellence
• Oversee TMF quality and inspection readiness across the study portfolio, identify evidence gaps, manage risks, and drive remediation
• Manage functional operations including resources, budgets, capacity planning, vendors, training, and business continuity
• Drive continuous improvement of TMF processes, standards, SOPs, and systems to strengthen evidence quality and compliance
• Partner with cross-functional stakeholders to resolve complex evidence issues and implement sustainable improvements
• Establish performance metrics and provide strategic insights to senior leadership on evidence quality, inspection readiness, risks, and portfolio trends
• Provide strategic oversight of audits and regulatory inspections, ensuring effective preparation and lessons learned implementation

Key requirements

• Degree educated
• Proven experience in life sciences or a related field (biopharmaceutical clinical research)
• Proven leadership experience managing and developing teams
• Strong expertise in TMF Operations, inspection readiness, regulatory inspections, and external vendor oversight
• In-depth knowledge of global GCP requirements, clinical trial documentation, regulatory compliance, and risk-based oversight
• Experience managing cross-functional projects, budgets, resources, timelines, and quality metrics in a matrix organization
• Strong strategic leadership, stakeholder management, change management, and communication skills

• Strong leadership and people management
• Excellent stakeholder management
• Effective change management and communication
• TMF Operations
• Inspection readiness
• Regulatory inspections

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