Director, Clinical Monitoring Strategy and Oversight

The Role 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.Here's What You’ll DoMonitoring Strategy LeadershipDefine 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)Risk-Based Monitoring and OversightLead 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.CRO and Vendor OversightProvide 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.Innovation and Digital TransformationChampion 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.Organizational Capability and Continuous ImprovementBuild 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.Here’s What You’ll Need (Basic Qualifications)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%.Pay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Competitive healthcare, plus voluntary benefit programs to support your unique needsA holistic approach to well-being, with access to fitness, mindfulness, and mental health supportFamily planning benefits, including fertility, adoption, and surrogacy supportGenerous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investments to help you plan for the futureLocation-specific perks and extrasThe salary range for this role is $167,000.00 - $300,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal OpportunitiesModerna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. AccommodationsWe’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at View email address on click.appcast.io. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. -SummaryLocation: Cambridge, Massachusetts; Clinical DevelopmentType: Full time