Vice President, Head of Clinical Operations

ModernaTX • Cambridge, MA

2d • Hybrid

About The Position

Moderna is seeking an enterprise leader to set the strategic direction for global clinical trial operations across its clinical development portfolio, including Oncology, Therapeutics, Infectious Disease, and future therapeutic areas and modalities. The role leads the organization responsible for translating development strategy into executable clinical plans and delivering studies to high standards of quality, ethics, participant safety, regulatory compliance, timelines, budgets, resource management, and external partnerships. The successful candidate will shape global portfolio planning and execution while developing the organization, operating models, digital capabilities, and data-driven approaches needed to accelerate development and patient impact.

The Vice President will lead and develop the global Clinical Operations organization, guide portfolio and study leaders, align operational plans and resourcing with therapeutic-area and enterprise priorities, and manage portfolio budgets and resources. The role drives operational excellence, scalable processes, performance metrics, and use of generative AI, advanced analytics, automation, and other digital tools. It also oversees outsourcing strategy and CRO and vendor relationships, represents Clinical Operations in leadership and governance forums, supports audits and regulatory inspections, and contributes to Global Development Operations leadership priorities. The position reports to the Senior Vice President, Global Development Operations.

The position is based in Cambridge, Massachusetts, in a 70/30 in-office work model. Moderna describes its work environment as smoke-free, alcohol-free, and drug-free. Employment is contingent on eligibility to access export-controlled information; only U.S. persons are eligible, and Moderna cannot sponsor non-U.S. persons for an export control license.

Requirements

• Bachelor’s degree required.
• 15 or more years of progressive clinical trial management and clinical operations leadership experience in the biotechnology, pharmaceutical, or CRO industry.
• Deep experience leading early- and late-stage global clinical operations across a diverse therapeutic portfolio.
• Substantial experience across all phases of drug and/or vaccine development, with a demonstrated record of 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.
• Strong knowledge of GCP guidelines and applicable clinical trial regulations.
• Thorough command of FDA and ICH GCP guidelines and expectations for 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, including the ability to engage across organizational levels and with external stakeholders.
• Strong understanding of clinical study planning, protocol execution, budget management, vendor oversight, risk management, inspection readiness, and operational governance.
• Ability to move between enterprise-level strategy and hands-on issue resolution.
• Enterprise leadership capability, including achieving results through others in a complex, matrixed, multidisciplinary environment.
• Team-building, coaching, talent-development, and collaboration skills, with the ability to inspire and motivate leaders and teams.
• Ability to create clarity, drive accountability, and make sound decisions in a fast-paced, evolving environment.
• Resilience, adaptability, and ability to pivot as portfolio, business, or operational priorities change.
• Ability to manage multiple projects, priorities, and stakeholders across a global portfolio.
• Strong cross-functional partnership skills with Development, Regulatory, Pharmacovigilance, Quality Assurance, Finance, Strategic Partnerships, Legal, Data Management, Biometrics, and other functions.
• Experience establishing and maintaining relationships with key opinion leaders, investigators, site networks, external collaborators, and senior vendor/CRO partners.
• Ability to represent Clinical Operations in governance forums, executive discussions, external collaborations, and regulatory or inspection-related interactions.
• Ability to meet U.S. person eligibility requirements for access to export-controlled information.

Nice To Haves

• An advanced degree or professional certification in a healthcare-related or scientific discipline.
• Experience across multiple therapeutic areas, including vaccines/infectious disease, oncology, autoimmune disease, rare disease, or other complex development programs.
• Experience directly participating in global regulatory GxP inspections, including sponsor and/or investigator site inspections.

Responsibilities

• Set strategic direction for global clinical trial operations across Moderna’s clinical development portfolio.
• Lead the global Clinical Operations organization responsible for planning, executing, delivering, and reporting clinical studies across all development phases.
• Maintain high standards for study quality, ethics, participant safety, regulatory compliance, operational discipline, budget accountability, and timelines.
• Lead, mentor, and develop a high-performing global Clinical Operations team and foster accountability, collaboration, continuous improvement, ownership, and operational excellence.
• Provide direction to portfolio and franchise leaders, Program Clinical Operations Leads, and study Clinical Operations Leads.
• Partner with Therapeutic Area Development Heads and functional line leaders to turn portfolio and development strategy into operational plans, resourcing models, timelines, budget assumptions, and delivery priorities.
• Prioritize and manage the Clinical Operations portfolio, deploying or reallocating resources in response to clinical data, portfolio changes, development needs, and business priorities.
• Manage Clinical Operations budgets and resources in alignment with long-range planning, annual planning, and periodic budget reviews.
• Implement process improvements, best practices, data-driven planning, performance metrics, and scalable operating models to improve predictability, quality, speed, and execution.
• Enable teams to use generative AI, advanced analytics, automation, and other digital tools for scenario planning, portfolio insights, decision-making, productivity, and faster learning.
• Build and maintain relationships with internal and external stakeholders, including regulatory authorities, investigators, site networks, vendors, CRO partners, government or funding collaborators, and joint development partners.
• Shape and support global clinical outsourcing strategies, 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, providing operational perspectives, risk assessments, scenario planning, and data-driven recommendations.
• Partner with Finance, Regulatory, Pharmacovigilance, Quality, Strategic Partnerships, Therapeutic Area leadership, and other functions to align resources, timelines, budgets, vendor strategies, and priorities.
• Represent Moderna externally, as appropriate, and communicate its Clinical Operations capabilities and clinical development portfolio.
• Oversee, collaborate on, and contribute to GCP audits and regulatory inspections related to clinical trial conduct, ensuring organizational readiness and sustained compliance.
• Contribute to Global Development Operations leadership priorities, including functional initiatives, resourcing strategies, organizational design, operating-model evolution, talent development, and culture.
• Address complex study and portfolio challenges, anticipate operational risk, and make high-quality decisions in a fast-moving development environment.

Benefits

• Competitive healthcare and voluntary benefit programs.
• Well-being resources, including 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 investment programs.
• Location-specific perks and extras.
• Potential eligibility for an annual discretionary bonus, other incentive compensation, or an equity award, subject to plan eligibility criteria and individual performance.

What This Job Offers

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