Director, Study Evidence & Inspection Readiness

Amgen Inc.; United States; Remote; USD 170.000 - 210.000; Vollzeit

Zusammenfassung

Amgen Inc. is seeking a Director of Study Evidence & Readiness to lead TMF Operations and Inspection Readiness, ensuring evidence is complete, retrievable, and inspection-ready across studies.

You will manage global teams, define metrics, and drive improvements in TMF health and evidence governance. Qualified candidates will have a doctorate with substantial experience in TMF, inspection readiness, and senior leadership; sponsorship is not guaranteed, and competitive benefits apply.

Qualifikationen

• Doctorate degree & 4 years of directly related experience or equivalent OR
• Master’s degree & 8 years of directly related experience or equivalent OR
• Bachelor’s degree & 10 years of directly related experience or equivalent
• AND 4 years of direct managerial and/or leadership experience or equivalent
• PhD, PharmD, MSc, BSc, or RN qualification.
• Leadership experience managing direct reports, including management-level staff.
• Experience in TMF operations and inspection readiness, preparation, inspection support, or response.

Aufgaben

• Set the strategy and priorities for TMF Operations and Inspection Readiness, aligning day-to-day evidence stewardship with continuous inspection readiness.
• Lead and develop global teams, including line management of Inspection Readiness Senior Managers and Managers; set clear goals, manage performance and engagement, and build succession and capability plans.
• Provide integrated oversight of TMF health, critical evidence, inspection readiness, and material evidence gaps across the study portfolio; establish meaningful metrics, thresholds, and escalation recommendations.
• Plan and manage departmental structure, capacity, resources, budget, suppliers, training, and business continuity to meet portfolio needs.
• Lead improvement initiatives that strengthen evidence quality, completeness, retrievability, and readiness; represent the function in process improvement, standards development, and integration work.
• Develop and maintain effective TMF and inspection-readiness processes, policies, SOPs, work instructions, and related materials, applying current procedures, industry practice, and relevant regulatory expectations.
• Partner cross-functionally to resolve evidence issues, interpret trends, apply root-cause insights, and drive sustainable improvement.
• Provide leadership reporting on evidence health, readiness risks, remediation progress, and portfolio trends; contribute to relevant leadership forums and governance committees.
• Support audits and inspections, including preparation, response support, and lessons learned for TMF and inspection-readiness process areas; build strong relationships with internal and external experts.

Kenntnisse

TMF Operations

Inspection Readiness

Leadership

Cross-functional

Global Teams

Ausbildung

PhD, PharmD, MSc, BSc, or RN

Doctorate/Master's/Bachelor's with related experience

Jobbeschreibung

Amgen Inc. is seeking a Director of Study Evidence & Readiness to lead TMF Operations and Inspection Readiness, ensuring evidence is complete, retrievable, and inspection-ready across studies.

You will manage global teams, define metrics, and drive improvements in TMF health and evidence governance. Qualified candidates will have a doctorate with substantial experience in TMF, inspection readiness, and senior leadership; sponsorship is not guaranteed, and competitive benefits apply.