Director of Clinical Site Monitoring and Oversight
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Job Description
Leading Amgen’s US clinical site monitoring strategy for innovative biotech medicines. Overseeing risk-based monitoring, CRO performance, analytics, compliance, and distributed clinical operations teams.
Responsibilities:
- Define and lead Amgen’s US clinical site monitoring strategy
- Establish and maintain enterprise standards for on-site, remote, centralized, and risk-based monitoring activities
- Ensure strategy and execution of field monitoring excellence while optimizing central monitoring
- Drive evolution of 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
- Collaborate with Clinical Operations leadership to integrate monitoring strategies into study planning, execution, and oversight models
- Build and oversee a team of internal and FSP clinical research associates
- Lead implementation and enhancement of risk-based monitoring approaches across the portfolio
- Partner with Clinical Risk, Compliance, Systems, Data Management, Biostatistics, Medical, Quality, and FSP teams
- Oversee monitoring plans, procedures, governance, and study-risk-based monitoring intensity
- Establish monitoring oversight processes to identify, escalate, and mitigate quality, compliance, and operational risks
- Provide strategic oversight of CRO monitoring performance
- Establish monitoring performance metrics, dashboards, and governance frameworks
- Lead escalation and resolution of systemic monitoring issues and compliance concerns
- Lead, coach, and develop CRA leaders, including performance management and succession planning
- Build organizational capabilities, resourcing, and operating models for regional portfolio requirements
- Foster a high-performing, inclusive, accountable, and patient-focused culture across distributed teams
- Lead organizational changes and adoption of new operating models, technologies, and monitoring approaches
- Set regional delivery goals, operating expectations, and performance standards across clinical trial operations
- Establish frameworks for monitoring performance metrics and best practices across hubs and countries
- Advance centralized and analytical monitoring capabilities as part of the monitoring and RBQM strategy
Requirements:
- Doctorate degree and 4 years of clinical research experience OR Master’s degree and 7 years of clinical research experience OR 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 utilizing clinical analytics, RBQM platforms, monitoring technologies, and data visualization tools
- 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%
Benefits:
- Comprehensive employee benefits package
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Work/life balance support
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