US Director of Clinical Site Monitoring and Oversight

Amgen•Thousand Oaks, CA

4d•$195,876 - $265,008

About The Position

The US Director of Clinical Site Monitoring and Oversight provides strategic leadership for Amgen’s US clinical site monitoring. The role defines, implements, and continually evolves monitoring strategies to protect patient safety, preserve data integrity, ensure protocol compliance, and promote operational excellence. It advances monitoring practices through analytics, technology, and operational improvements while supporting consistent oversight and inspection readiness across clinical programs. The leader owns the monitoring strategy business process and serves as a subject matter expert for senior leadership, governance committees, inspections, audits, and regulatory interactions. The role establishes standards for on-site, remote, centralized, and risk-based monitoring; partners with clinical and quality functions to tailor monitoring to study risks; and provides strategic oversight of CRO and vendor monitoring performance. It also builds and leads internal and FSP CRA teams, develops organizational capabilities, and guides regional and country operations leaders.

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 phases of development.
Strong expertise in risk-based monitoring, centralized monitoring, remote monitoring, and CRO oversight models.
Experience using clinical analytics, RBQM platforms, monitoring technologies, and data visualization tools to support risk-based decision-making.
Proven 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 the 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.
Optimize field monitoring and central monitoring execution.
Evolve monitoring methodologies using 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.
Integrate monitoring strategies into study planning, execution, and oversight in collaboration with Clinical Operations leadership.
Build and oversee internal and FSP clinical research associate teams.
Implement and continuously enhance risk-based monitoring across the portfolio.
Partner with Clinical Risk, Compliance, and Systems teams to align monitoring with Critical to Quality factors, Key Risk Indicators, Quality Tolerance Limits, centralized monitoring, and oversight activities.
Oversee monitoring procedures and governance, tailoring monitoring intensity and methods to study risks.
Promote consistency in monitoring practices.
Establish monitoring oversight processes that identify, escalate, and mitigate emerging quality, compliance, and operational risks.
Provide strategic oversight of CRO monitoring performance and alignment with Amgen standards, ICH GCP, quality expectations, and contractual obligations.
Establish monitoring 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.
Lead US clinical monitoring strategy and execution, integrating risk-based, centralized, remote, and other monitoring approaches with relevant cross-functional teams.
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 Amgen’s Quality by Design commitment.
Coach and develop CRA leaders, including performance management, succession planning, and leadership bench development.
Build the organizational capabilities, resourcing, and operating model needed for current and future regional portfolio requirements.
Foster a high-performing, inclusive, accountable, and patient-focused culture across geographically distributed teams.
Lead organizational change and adoption of new operating models, technologies, monitoring approaches, and clinical development practices.
Oversee regional clinical trial delivery and hold line management authority for regional and country operations leaders, including performance management, talent development, succession planning, and capability building.
Set regional delivery goals, operating expectations, and performance standards across study start-up, site engagement, monitoring, execution, and closeout.
Establish strategies with GSSO leadership to increase and sustain high monitoring performance and quality, and develop performance frameworks and monitoring best practices across Hubs and countries.
Partner with Data Management to evolve centralized and analytical monitoring as part of the monitoring and RBQM strategy.

Benefits

Retirement and Savings Plan with company contributions
Group medical coverage
Dental coverage
Vision coverage
Life insurance
Disability insurance
Flexible spending accounts
Discretionary annual bonus program, or a 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