Director, Study Evidence & Readiness

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead the Study Evidence and Readiness function, encompassing TMF Operations and Inspection Readiness, to ensure that clinical studies are continuously able to demonstrate appropriate trial conduct through complete, reliable, retrievable, and inspection-ready evidence.

Responsibilities

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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications

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

Preferred Qualifications

PhD, PharmD, MSc, BSc, or RN qualification.