US Director of Clinical Site Monitoring and Oversight

Accountabilities

• Define and lead Amgen’s US clinical site monitoring strategy, ensuring alignment with corporate quality objectives, regulatory expectations, and industry best practices.

• Establish and maintain enterprise standards for on-site, remote, centralized, and risk-based monitoring activities across all clinical programs.

• Ensure strategy and execution of field monitoring excellence optimizing central monitoring.

• Drive the evolution of monitoring methodologies through the incorporation of advanced analytics, automation, AI-enabled insights, and innovative oversight approaches.

• Serve as the monitoring strategy business process owner (BPO) and subject matter expert (SME) for senior leadership, governance committees, inspections, audits, and regulatory interactions.

• Collaborate with Clinical Operations leadership to ensure monitoring strategies are integrated into study planning, execution, and oversight models.

• Build and oversee a team of internal and FSP clinical research associates (CRAs)

• Lead the strategic implementation and continuous enhancement of risk-based monitoring approaches across the portfolio.

• Partner with Clinical Risk, Compliance & Systems teams to ensure alignment between monitoring strategies, Critical to Quality (CTQ) factors, Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), centralized monitoring and monitoring oversight activities.

• Oversee associated procedures and governance of monitoring plans, ensuring monitoring intensity and methodologies are appropriately tailored to study risks.

• Drive consistency in monitoring practices.

Preferred Qualificationsnice to have

• Minimum of 12 years of experience in clinical research, clinical operations, clinical quality, or related functions, including significant experience leading clinical monitoring strategy and oversight in global clinical trials.

• Deep knowledge of ICH GCP, ICH E6(R3), ICH E8(R1), and global regulatory expectations for risk-based monitoring and clinical trial oversight.

• Demonstrated success developing and implementing monitoring strategies across multiple therapeutic areas and phases of development.

• Strong expertise in risk-based monitoring, centralized monitoring, remote monitoring, and CRO oversight models.

• Experience utilizing clinical analytics, RBQM platforms, monitoring technologies, and data visualization tools to drive risk-based decision making.

• Proven ability to influence senior stakeholders and lead complex cross-functional initiatives within a global matrix organization.

• Strong leadership, change management, relationship management, and organizational development capabilities.

• Excellent communication, presentation, and stakeholder management skills.

• Ability to travel up to 25%.

• Serves as the functional leader for US clinical monitoring strategy and execution, integrating risk-based, centralized, remote and other monitoring approaches in partnership with relevant cross-functional capabilities.

• Partners closely with Clinical Operations, Clinical Risk & Compliance, Data Management, Biostatistics, Medical, Quality, and FSP partners

• Ensures monitoring approaches are aligned with regulatory expectations, ICH GCP, quality objectives, and Amgen’s commitment to Quality by Design.

What you can expect of us

• 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.