Senior Director, Clinical Risk & Insights

Amgen; United States; Remote; USD 204,000 - 277,000; Full time

Job summary

Amgen is seeking a Senior Director, Clinical Risk & Insights to lead RCA, systemic investigation, and clinical execution risk intelligence across portfolios.

You will set the RCA methodology, triage major issues, sponsor RBQM strategy, and translate findings into executive insight to drive sustained improvement.

The role partners with Global Clinical Compliance & Support, Study Delivery Teams, CPSO, and external collaborators to embed risk-informed execution.

Qualifications

• Doctorate or Master’s degree with extensive related experience and leadership experience.
• Strong background in clinical risk management and RBQM.
• Experience with quality analytics and cross-functional collaboration.

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.

Skills

Clinical risk management

RBQM experience

Quality analytics

Leading teams

Education

MD/PhD/PharmD or Master’s degree

Life sciences experience

Tools

Analytics tools

Automation tools

Knowledge management

Job description

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.

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

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:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary Range 204,431.80USD -276,584.20 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen