Director of Clinical Site Monitoring and Oversight

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $195.9k - $265k / year

⏰ Full Time

🔴 Lead

👔 Director

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• 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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