Vice President, Head of Clinical Operations
Moderna · Cambridge, Massachusetts, United States
The Role
Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.
Moderna is strengthening its presence in Cambridge, Massachusetts, home to our global headquarters and a center of mRNA innovation. Working closely with leading universities and research institutions, our Cambridge team advances groundbreaking science that shapes the future of medicine. We welcome talent driven by innovation and committed to improving global health.
This is an enterprise leadership opportunity to set the strategic direction for global clinical trial operations across Moderna’s clinical development portfolio, spanning Oncology, Therapeutics, Infectious Disease, and future therapeutic areas and modalities.
You will lead the global organization responsible for translating development strategy into high-quality, executable clinical plans, ensuring studies are delivered with rigor across quality, ethics, participant safety, compliance, timelines, budgets, resources, and external partnerships.
Operating with strategic vision and hands-on operational depth, you will shape how Moderna plans and executes its clinical portfolio globally while building the organization, operating models, digital capabilities, and data-driven approaches needed to accelerate development and patient impact.
Here’s What You’ll Do
- Set the strategic direction for global clinical trial operations across Moderna’s clinical development portfolio, ensuring Clinical Operations priorities remain aligned with enterprise, development, and therapeutic area objectives.
- Lead the global Clinical Operations organization accountable for the planning, execution, delivery, and reporting of clinical studies across all phases of development, maintaining the highest standards of quality, ethics, participant safety, regulatory compliance, operational discipline, budget accountability, and timeline performance.
- Lead, mentor, and develop a high-performing global Clinical Operations team, fostering a culture of accountability, collaboration, continuous improvement, ownership, operational excellence, and strong leadership at every level of the organization.
- Provide leadership and direction to portfolio and franchise leaders, Program Clinical Operations Leads (PCOLs), and study Clinical Operations Leads (COLs), enabling successful execution of global clinical studies in accordance with ICH-GCP, applicable regulations, and Moderna standards.
- Partner closely with Therapeutic Area Development Heads and functional line leaders to translate portfolio and development strategy into executable operational plans, resourcing models, study timelines, budget assumptions, and delivery priorities.
- Ensure the Clinical Operations portfolio is appropriately prioritized, resourced, and actively managed, deploying and reallocating resources in response to emerging clinical data, portfolio changes, development needs, and shifting business priorities.
- Manage Clinical Operations budgets and resources with strong financial and operational discipline, ensuring alignment with long-range planning, annual planning, and periodic budget review cycles.
- Drive operational excellence across the portfolio by identifying and implementing process improvements, best practices, data-driven planning approaches, performance metrics, and scalable operating models that improve predictability, quality, speed, and execution.
- Create opportunities for Clinical Operations leaders and teams to work closely with Generative AI, advanced analytics, automation, and other digital tools to strengthen scenario planning, portfolio insights, operational decision-making, productivity, and the speed at which teams can learn and act.
- Develop and maintain strong relationships with critical internal and external stakeholders, including regulatory authorities, investigators, strategic site networks, vendors, CRO partners, government or funding collaborators, and joint development partners.
- Shape and support global clinical outsourcing strategies and plans, including CRO and vendor selection, oversight, governance, performance management, issue escalation, and strategic partnership engagement.
- Represent Clinical Operations on cross-functional leadership and governance forums, bringing a clear operational perspective, rigorous risk assessment, scenario planning, and data-driven recommendations to development and portfolio decisions.
- Partner closely with Finance, Regulatory, Pharmacovigilance, Quality, Strategic Partnerships, Therapeutic Area leadership, and other functions to ensure resources, timelines, budgets, vendor strategies, and operational priorities remain aligned with Moderna’s business and development objectives.
- Represent Moderna externally, as appropriate, communicating the strength of Moderna’s Clinical Operations capabilities and broader clinical development portfolio to key external stakeholders.
- Oversee, collaborate on, and contribute to activities supporting GCP audits and regulatory inspections related to clinical trial conduct, ensuring organizational readiness and sustained compliance.
- Actively contribute to Global Development Operations leadership priorities, including functional initiatives, resourcing strategies, organizational design, evolution of the operating model, talent development, and culture.
- Serve as a senior enterprise leader capable of moving between strategy and execution, solving complex study and portfolio challenges, anticipating operational risk, and making high-quality decisions in a fast-moving development environment.
- Report to the Senior Vice President, Global Development Operations, serving as a key member of the broader GDO leadership organization and helping shape the future direction and capabilities of global development operations.
The key Moderna Mindsets you’ll need to succeed in the role:
- “We act with dynamic range, driving strategy and execution at the same time at every step.”
- “We behave like owners. The solutions we’re building go beyond any job description.”
Here's What You'll Need (Basic Qualifications)
Education and Experience
- Bachelor's degree required; advanced degree or professional certification in a healthcare-related or scientific discipline preferred.
- 15+ years of progressive clinical trial management and clinical operations leadership experience within the biotechnology, pharmaceutical, or CRO industry.
- Deep experience leading both early and late-stage global clinical operations across a diverse therapeutic portfolio; experience across multiple therapeutic areas, including vaccines/infectious disease, oncology, autoimmune, rare disease, or other complex development programs is highly desired.
- Substantial experience across all phases of drug and/or vaccine development, with a proven track record leading late-stage and pivotal studies through global license and market applications.
- Demonstrated experience building, managing, and developing global clinical operations teams and leaders.
- Demonstrated experience overseeing clinical operations across CRO partners, vendors, strategic site networks, and external collaborators.
- Experience directly participating in global regulatory GxP inspections, including sponsor and/or investigator site inspections, preferred.
Knowledge and Skills- Strong knowledge of GCP guidelines and applicable clinical trial regulations.
- Thorough command of FDA and ICH GCP guidelines and expectations for the conduct of clinical studies in the United States, United Kingdom, Europe, Japan, and other global regions.
- Superior strategic thinking, operational planning, portfolio prioritization, and problem-solving abilities.
- Excellent communication, negotiation, and influencing skills, with the ability to engage effectively across all levels of the organization and with external stakeholders.
- Strong understanding of