US Director of Clinical Site Monitoring and Oversight

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.

US Director of Clinical Site Monitoring and Oversight

What you will do

Let’s do this. Let’s change the world. In this vital role you will be the strategic leadership and oversight for Amgen’s clinical site monitoring in the US. This role is accountable for defining, implementing, and continuously evolving innovative monitoring strategies that ensure patient safety, data integrity, protocol compliance, and operational excellence. This leader drives strategic transformation of monitoring practices through analytics, technology innovation, and operational excellence while ensuring consistent oversight and inspection readiness across all clinical programs.

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.

CRO and Vendor Oversight

• Establish a monitoring oversight process to ensure oversight processes proactively identify, escalate, and mitigate emerging quality, compliance, and operational risks.

• Provide strategic oversight of CRO monitoring performance, ensuring alignment with Amgen standards, ICH GCP, quality expectations, and contractual obligations.

• Establish monitoring performance metrics, dashboards, and governance frameworks to assess effectiveness, efficiency, and quality outcomes.

• Lead escalation and resolution of systemic monitoring issues, compliance concerns, and performance trends.

• Partner with Alliance (Vendor) Management and Clinical Operations to optimize monitoring delivery models and oversight practices.

Responsibilities

• 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.

Capability Building & People Leadership

• Lead, coach, and develop CRA leaders, including performance management, succession planning, and leadership bench development.

• Build the organizational capabilities, resourcing, and operating model needed to meet current and future regional portfolio requirements.

• Foster a high-performing, inclusive, accountable, and patient-focused culture across geographically distributed teams.

…