Director, Study Evidence & Readiness

Amgen; United States; Vor Ort; USD 180.000 - 260.000; Vollzeit

Zusammenfassung

Amgen is seeking a Director of Study Evidence & Readiness to lead TMF Operations and Inspection Readiness, ensuring continuous, inspection-ready evidence across clinical studies. You will manage global teams, set priorities, and drive improvements in evidence health and readiness.

The role requires strong regulatory knowledge, cross-functional leadership, and experience in TMF processes, with a track record of delivering strategic, scalable solutions in a matrix environment.

Qualifikationen

• Doctorate or equivalent with 4 years related experience, or a Master's with 8 years, or a Bachelor's with 10 years.
• Minimum 4 years of direct managerial/leadership experience.
• Experience in TMF operations and inspection readiness.
• Knowledge of global GCP and regulatory expectations.
• Experience leading cross-functional teams in a matrix organization.

Aufgaben

• Set the strategy and priorities for TMF Operations and Inspection Readiness.
• Lead and develop global teams; set goals, manage performance, and build capability plans.
• Oversee TMF health, evidence readiness, and gaps across the study portfolio; define metrics.

Kenntnisse

Leadership

Regulatory knowledge

TMF operations

Cross-functional collaboration

Strategic planning

Ausbildung

Doctorate degree

Master's degree

Bachelor's degree

Jobbeschreibung

Career Category
Clinical
Job Description
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.

Director, Study Evidence & Readiness

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.
• 11 years of work experience in life sciences or a medically related field, including 8 years in biopharmaceutical clinical research at a biotechnology company, pharmaceutical company, or CRO.
• Leadership experience managing direct reports, including management-level staff.
• Experience in TMF operations and inspection readiness, preparation, inspection support, or response.
• Experience managing or overseeing external clinical research vendors.
• Knowledge of global GCP and regulatory expectations for clinical trial conduct, TMF records, and inspection readiness, along with risk-based oversight, evidence health, resource planning, and organizational capacity.
• Experience leading cross-functional work in a matrix organization, including projects, budgets, timelines, and quality metrics; able to build relationships, lead change, develop high-performing teams, and communicate clearly.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen of