Director, Clinical Monitoring Strategy and Oversight

ModernaTX • Cambridge, MA

2d • Onsite

About The Position

The Director, Clinical Monitoring Strategy and Oversight provides strategic leadership and oversight for Moderna's clinical monitoring model across the global clinical development portfolio. This role is accountable for defining, implementing, and continuously evolving innovative monitoring strategies that ensure patient safety, data integrity, protocol compliance, and operational excellence. The Director serves as the functional leader for monitoring strategy, integrating risk-based monitoring (RBM), centralized monitoring, remote monitoring, and emerging digital capabilities into a scalable oversight framework for both insourced and outsourced monitoring strategies. Working closely with Clinical Operations, Clinical Risk & Compliance, Data Management, Biostatistics, Medical, Quality, and CRO partners, this role ensures monitoring approaches are aligned with regulatory expectations, quality objectives, and Moderna's commitment to Quality by Design. 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.

Requirements

• Bachelor's degree required in Life Sciences, Healthcare, Nursing, Pharmacy, or related field, or equivalent work experience required; advanced degree preferred.
• Minimum of 13 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 to drive risk-based decision making.
• Proven ability to influence senior stakeholders and lead complex cross-functional initiatives within a global matrix organization.
• Strong leadership, change management, and organizational development capabilities.
• Excellent communication, presentation, and stakeholder management skills.
• Ability to travel up to 25%.

Nice To Haves

• advanced degree preferred

Responsibilities

• Define and lead Moderna's global clinical monitoring strategy, ensuring alignment with corporate quality objectives, regulatory expectations, and industry best practices for both insourced and outsource monitoring strategies.
• Establish and maintain enterprise standards for on-site, remote, centralized, and risk-based monitoring activities across all clinical programs.
• 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 Moderna clinical monitors (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.
• Oversee the Monitoring Oversight team to ensure oversight processes proactively identify, escalate, and mitigate emerging quality, compliance, and operational risks.
• Drive consistency in monitoring practices across internal teams and CRO partners.
• Provide strategic oversight of CRO monitoring performance, ensuring alignment with Moderna standards, 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.
• Champion modernization of clinical monitoring through adoption of digital health technologies, remote monitoring capabilities, AI-enabled analytics, and emerging regulatory approaches.
• Evaluate and implement innovative monitoring technologies and platforms that improve risk detection, operational efficiency, and study quality.
• Collaborate with Data Science, Digital, and Technology organizations to develop scalable monitoring analytics and reporting capabilities.
• Monitor external trends and evolving regulatory guidance to ensure Moderna remains at the forefront of monitoring innovation.
• Build and foster a culture of quality, accountability, and risk-based decision making across monitoring functions.
• Lead development and implementation of enterprise monitoring training, competency frameworks, and best practices.
• Mentor and develop monitoring leaders and subject matter experts within Clinical Development.
• Drive continuous improvement initiatives to simplify processes, enhance scalability, and improve monitoring effectiveness.
• Establish KPIs and quality metrics to measure and mature monitoring performance across the clinical portfolio.

Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Director