Director, Study Evidence & TMF Readiness

Amgen Inc.; Thousand Oaks (CA); Hybrid; USD 186.000 - 251.000; Vollzeit

Benefits dieser Stelle

Retirement and Savings Plan

Stock-based long-term incentives

Flexible work models

Zusammenfassung

Amgen Inc. in Thousand Oaks, CA seeks a Director, Study Evidence & Readiness to lead TMF Operations and Inspection Readiness across the study portfolio.

You will set strategy, oversee evidence health, and drive continuous improvement to ensure audit readiness and robust documentation. The role requires doctoral-level or equivalent experience with leadership, strong GCP/regulatory knowledge, and experience managing cross-functional teams and external partners.

Qualifikationen

• Doctorate or equivalent with relevant clinical research leadership experience.
• Strong knowledge of GCP, TMF records, and regulatory expectations.

Aufgaben

• Set strategy and priorities for TMF Operations and Inspection Readiness.
• Lead and develop global teams; set goals and build capability.
• Oversee TMF health, evidence gaps, metrics and escalation.
• Plan resources, budgets, and suppliers to meet portfolio needs.
• Lead process improvements and develop TMF-related SOPs.
• Collaborate cross-functionally to resolve evidence issues and drive improvements.

Kenntnisse

TMF Operations

Inspection Readiness

Cross-functional leadership

Vendor management

Regulatory knowledge

Ausbildung

Doctorate degree

Master’s degree

Bachelor’s degree

Jobbeschreibung

Amgen Inc. in Thousand Oaks, CA seeks a Director, Study Evidence & Readiness to lead TMF Operations and Inspection Readiness across the study portfolio.

You will set strategy, oversee evidence health, and drive continuous improvement to ensure audit readiness and robust documentation. The role requires doctoral-level or equivalent experience with leadership, strong GCP/regulatory knowledge, and experience managing cross-functional teams and external partners.