Senior Director, Clinical Risk & Insights

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.

Senior Director, Clinical Risk & Insights

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead Clinical Risk & Insights as a capability focused on Root Cause Analysis (RCA), systemic investigation, and clinical execution risk intelligence. Ensure significant, complex, recurring, and cross-portfolio issues generate clear executive insight, informed decisions, and sustained improvement. Set the GDO wide RCA approach and integrate systemic learning with portfolio risk intelligence, and the strategic direction of Risk-Based Quality Management (RBQM).

Responsibilities:

• Set RCA methodology, investigation standards, guidance, and capability materials; lead complex investigations and coach teams to identify systemic causes and prevent recurrence.
• Own triage and executive escalation of significant, complex, recurring, and cross-portfolio clinical execution issues; prioritize and direct RCA support.
• Provide clinical risk insight, systemic learning, trend reports, and decision briefs to Management Review, the Clinical Trial Compliance Committee (CTCC), and CPSO leadership forums.
• Challenge superficial root causes and ineffective CAPAs; recommend CAPA effectiveness actions, control redesign, intervention, or senior sponsorship when systemic clinical execution risk is identified.
• Sponsor cross-functional improvement when system or control failures extend beyond one study or function; influence sustained change and embed risk-informed execution.
• Sponsor the RBQM strategy and maturity roadmap, connecting systemic learning and portfolio risk intelligence with prospective risk identification and future study execution.
• Lead and develop the department; set strategy and priorities, manage resources, budget, talent, and external expertise, and build organizational RCA capability.
• Build strong relationships across Global Clinical Compliance & Support, Study Delivery Teams (SDTs), CPSO, GDO, R&D Quality, global networks, and external partners; contribute to relevant governance and standards.

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 directly related experience or
• Master’s degree + 8 years directly related experience or
• Bachelor’s degree + 10 years directly related experience
• AND 4 years direct managerial and/or leadership experience

Preferred Qualifications:

M.D., D.O., PhD, PharmD, or Master’s degree.

11 years of experience in life sciences or a medically related field, including 8 years in biopharmaceutical clinical research.

Experience managing direct reports, including management-level staff.

Clinical risk management or RBQM experience, including study risk assessments, mitigation strategies, Critical to Quality (CtQ) factors, Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs).

Experience analyzing quality event, audit, inspection, and readiness trends; operational excellence, continuous improvement, or quality intelligence.

Experience with analytics, automation, or knowledge-management tools; budget, resource, and organizational capacity management.

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 offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

…