US Director of Clinical Site Monitoring and Oversight

Amgen•Thousand Oaks, CA

About The Position

The US Director of Clinical Site Monitoring and Oversight provides strategic leadership and oversight for Amgen’s US clinical site monitoring. The role defines, implements, and continuously evolves monitoring strategies to support patient safety, data integrity, protocol compliance, and operational excellence. It leads the transformation of monitoring practices through analytics, technology innovation, and operational improvements, while maintaining consistent oversight and inspection readiness across clinical programs. The Director establishes enterprise standards for on-site, remote, centralized, and risk-based monitoring and serves as the monitoring strategy business process owner and subject matter expert for senior leadership, governance committees, inspections, audits, and regulatory interactions. The role works with Clinical Operations and cross-functional partners to integrate monitoring into study planning, execution, and oversight; builds and oversees internal and FSP CRA teams; and advances risk-based monitoring across the portfolio. The position also oversees monitoring procedures and plans, CRO monitoring performance, and monitoring governance. It establishes performance metrics, dashboards, and frameworks; leads escalation and resolution of systemic issues; and partners with Alliance Management and Clinical Operations to optimize vendor monitoring delivery. As the functional and regional leader, the Director develops people and organizational capabilities, sets delivery goals and performance standards, guides adoption of new operating models and technologies, and supports high-performing, inclusive, patient-focused teams. Travel up to 25% is expected.

Requirements

Doctorate degree and 4 years of clinical research experience, or a master’s degree and 7 years of clinical research experience, or a bachelor’s degree and 9 years of clinical research experience.
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 development phases.
Strong expertise in risk-based, centralized, and remote monitoring, and CRO oversight models.
Experience using clinical analytics, RBQM platforms, monitoring technologies, and data visualization tools to support risk-based decision-making.
Ability to influence senior stakeholders and lead complex cross-functional initiatives in 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%.

Responsibilities

Define and lead Amgen’s US clinical site monitoring strategy in 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 across clinical programs.
Ensure effective field monitoring and optimize central monitoring.
Advance monitoring methodologies through advanced analytics, automation, AI-enabled insights, and innovative oversight approaches.
Serve as monitoring strategy business process owner and subject matter expert for senior leadership, governance committees, inspections, audits, and regulatory interactions.
Partner with Clinical Operations leadership to integrate monitoring strategies into study planning, execution, and oversight models.
Build and oversee internal and FSP clinical research associate teams.
Lead implementation and continuous enhancement of risk-based monitoring across the portfolio.
Partner with Clinical Risk, Compliance, and Systems teams to align strategies with CTQ factors, KRIs, QTLs, centralized monitoring, and oversight activities.
Oversee procedures and governance for monitoring plans, tailoring monitoring intensity and methods to study risks, and drive consistency in monitoring practices.
Establish processes for identifying, escalating, and mitigating emerging quality, compliance, and operational risks.
Provide strategic oversight of CRO monitoring performance and ensure 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 Management and Clinical Operations to optimize monitoring delivery models and oversight practices.
Lead US clinical monitoring strategy and execution, integrating risk-based, centralized, remote, and other monitoring approaches with relevant cross-functional capabilities.
Partner with Clinical Operations, Clinical Risk & Compliance, Data Management, Biostatistics, Medical, Quality, and FSP partners.
Ensure monitoring approaches align with regulatory expectations, ICH GCP, quality objectives, and Quality by Design.
Lead, coach, and develop CRA leaders, including performance management, succession planning, and leadership bench development.
Build organizational capabilities, resourcing, and operating models to meet current and future regional portfolio requirements.
Foster a high-performing, inclusive, accountable, and patient-focused culture across geographically distributed teams.
Lead organizational changes and adoption of new operating models, technologies, monitoring approaches, and clinical development practices.
Exercise regional oversight and delivery accountability for clinical trials, including line management of regional and country operations leaders.
Set regional delivery goals, operating expectations, and performance standards across study start-up, site engagement, monitoring, execution, and closeout.
Develop and implement strategies and frameworks for monitoring performance, field team leadership, best practices, and consistent standards across hubs and countries.
Partner with Data Management to evolve centralized and analytical monitoring as part of the overall monitoring and RBQM strategy.
Build high-performing regional and country teams.

Benefits

Health and welfare plans for staff and eligible dependents
Retirement and Savings Plan with company contributions
Group medical coverage
Dental coverage
Vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program, or sales-based incentive plan for field sales representatives
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Career development opportunities