Senior Director, Clinical Risk & Insights

1027 Amgen Limited; Thousand Oaks (CA); Hybrid; USD 204,000 - 277,000; Full time

Benefits offered by this job

Total rewards plan

Discretionary annual bonus

Stock-based incentives

Flexible work models

Retirement plan

Job summary

Amgen in Thousand Oaks, CA is seeking a Senior Director, Clinical Risk & Insights to lead RCA, systemic investigation, and RBQM strategy. You will set RCA standards, guide complex investigations, provide risk insights to management, and sponsor cross-functional improvements across SDTs, CPSO, and GDO.

You will lead and develop the department, set strategy and priorities, manage resources and external expertise, and build organizational RCA capability while collaborating with global Clinical

Qualifications

• Doctorate or Master’s level with substantial experience in life sciences or clinical research.
• Experience managing direct reports and leadership roles.
• 000000000

Responsibilities

• Set RCA methodology and lead complex investigations to identify systemic causes.
• Own triage and executive escalation of significant cross-portfolio issues.
• Provide clinical risk insight and trend reports to leadership forums.
• Challenge superficial root causes and implement CAPA effectiveness actions.
• Sponsor cross-functional improvement and embed risk-informed execution.
• Lead RBQM strategy and maturity roadmap across portfolios.
• Build RCA capability and manage resources, budget, and external expertise.
• Foster relationships across Global Clinical Compliance, SDTs, CPSO, and GDO.

Skills

Root Cause Analysis

Executive risk insight

Leadership experience

Clinical risk management

Stakeholder collaboration

Education

Doctorate degree + 4 years related experience

Master’s degree + 8 years related experience

Bachelor’s degree + 10 years related experience

Tools

Analytics tools

Job description

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.

Senior Director, Clinical Risk & Insights

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.

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

• 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

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.

Salary Range 204,431.80USD -276,584.20 USD

Sponsorship

Sponsorship for this role is not guaranteed.

Equal Opportunity Employment

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.

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