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Moderna

Develops mRNA-based medicines for health

Vice President - Head of Clinical Operations

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeCambridge, MA, USA

About the Job

Requirements

  • A bachelor's degree is required; an advanced degree or professional certification in a healthcare-related or scientific discipline is preferred.
  • At least 15 years of progressive clinical trial management and clinical operations leadership experience in the biotechnology, pharmaceutical, or contract research organization industry.
  • Deep experience leading early- and late-stage global clinical operations across a diverse therapeutic portfolio; experience in multiple therapeutic areas, including vaccines or infectious disease, oncology, autoimmune disease, rare disease, or other complex development programs is highly desired.
  • Substantial experience across all phases of drug and/or vaccine development, including 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 contract research organization partners, vendors, strategic site networks, and external collaborators.
  • Strong knowledge of Good Clinical Practice guidelines and applicable clinical trial regulations.
  • Thorough command of FDA and ICH Good Clinical Practice 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.
  • Strong communication, negotiation, and influencing skills to engage across all 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 when required.
  • Proven enterprise leadership capability, including achieving results through others in a complex, matrixed, multidisciplinary environment.
  • Team-building, coaching, talent development, and collaboration skills to inspire and motivate leaders and teams.
  • Ability to create clarity, drive accountability, and make sound decisions in a fast-paced and 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.
  • Ability to partner cross-functionally with Development, Regulatory, Pharmacovigilance, Quality Assurance, Finance, Strategic Partnerships, Legal, Data Management, Biometrics, and other relevant functions.
  • Experience establishing and maintaining relationships with key opinion leaders, investigators, site networks, external collaborators, and senior vendor or contract research organization partners.
  • Ability to represent Clinical Operations credibly in governance forums, executive discussions, external collaborations, and regulatory or inspection-related interactions.

Responsibilities

  • Set strategic direction for global clinical trial operations across Moderna’s clinical development portfolio, aligning Clinical Operations priorities with enterprise, development, and therapeutic-area objectives.
  • Lead the global Clinical Operations organization responsible for planning, executing, delivering, and reporting clinical studies across all development phases, maintaining standards for 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, operational excellence, and leadership across the organization.
  • Provide leadership and direction to portfolio and franchise leaders, Program Clinical Operations Leads, and study Clinical Operations Leads to enable global clinical study execution under ICH-GCP, applicable regulations, and Moderna standards.
  • Partner with Therapeutic Area Development Heads and functional line leaders to turn portfolio and development strategy into operational plans, resourcing models, study timelines, budget assumptions, and delivery priorities.
  • Prioritize, resource, and actively manage the Clinical Operations portfolio, deploying and reallocating resources in response to clinical data, portfolio changes, development needs, and business priorities.
  • Manage Clinical Operations budgets and resources, aligning them with long-range planning, annual planning, and periodic budget reviews.
  • Drive operational excellence by implementing process improvements, best practices, data-driven planning, performance metrics, and scalable operating models to improve predictability, quality, speed, and execution.
  • Create opportunities for Clinical Operations leaders and teams to use generative artificial intelligence, advanced analytics, automation, and other digital tools for scenario planning, portfolio insights, operational decisions, productivity, and faster organizational learning and action.
  • Build and maintain relationships with internal and external stakeholders, including regulatory authorities, investigators, strategic site networks, vendors, contract research organization partners, government or funding collaborators, and joint development partners.
  • Shape and support global clinical outsourcing strategies, including contract research organization and vendor selection, oversight, governance, performance management, issue escalation, and strategic partnership engagement.
  • Represent Clinical Operations in cross-functional leadership and governance forums, providing operational perspectives, risk assessment, scenario planning, and data-driven recommendations for development and portfolio decisions.
  • Partner with Finance, Regulatory, Pharmacovigilance, Quality, Strategic Partnerships, Therapeutic Area leadership, and other functions to align resources, timelines, budgets, vendor strategies, and operational priorities with business and development objectives.
  • Represent Moderna externally as appropriate, communicating its Clinical Operations capabilities and clinical development portfolio to external stakeholders.
  • Oversee, collaborate on, and contribute to Good Clinical Practice 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.
  • Move between strategy and execution, solve complex study and portfolio challenges, anticipate operational risk, and make high-quality decisions in a fast-moving development environment.
  • Report to the Senior Vice President, Global Development Operations; serve as a key member of the broader Global Development Operations leadership organization and help shape its future direction and capabilities.

Desired Qualifications

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

About the Company

Moderna

Develops mRNA-based medicines for health

Moderna develops medicines built on messenger RNA (mRNA). Its products use mRNA delivered into cells to instruct them to produce specific proteins that can prevent or treat disease, with vaccines being a primary example. In practice, a dose delivers engineered mRNA into the body, cells translate it into a target protein, and the immune system responds or the protein modulates biology to combat disease. Moderna differentiates itself through its focus on building a whole mRNA medicines platform and in-house capabilities for designing, manufacturing, and scaling mRNA therapies, including rapid development and large-scale production. Its goal is to create a new category of medicines based on mRNA that can improve how diseases are discovered, developed, and treated, ultimately improving patient outcomes.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cambridge, MA
Founded
2010

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