VP, U.S. Medical Affairs

VP, U.S. Medical Affairs

Waltham, MA

Company Overview:

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.

Role Summary:

The VP, U.S. Medical Affairs is the senior U.S. medical leader with end-to-end accountability for U.S. medical launch readiness, execution, and early commercialization success for Dyne's first approved product. This role will continue to build, lead, and scale a high-impact U.S. Medical Affairs organization and serve as a critical leader capable of delivering excellence in a first-launch, high-visibility environment.

This position plays a critical leadership role in shaping Dyne's transition from a clinical-stage to a commercial-stage company, serving as a core member of cross-functional launch governance and a trusted strategic advisor to executive leadership and member of the US Leadership Team (USLT). The VP is accountable for defining and executing the U.S. medical strategy, ensuring scientific and medical excellence, mitigating medical risk, and driving impactful engagement with U.S. healthcare providers, payers, patient communities, and other external stakeholders.

The VP, U.S. Medical Affairs is a key member of the Global Medical Affairs Leadership Team and works in close collaboration with Global Medical Affairs, Commercial, Market Access, Clinical Development, Regulatory, and other functions to ensure seamless alignment and execution through approval, launch, and early lifecycle management. This is a unique opportunity to define and lead the U.S. medical strategy for Dyne's first commercial product and establish the foundation for future launches in a rapidly evolving rare disease portfolio.

This role is based in Waltham, MA.

Primary Responsibilities Include :

• Deliver a highly effective U.S. medical launch that enables appropriate, evidence-based adoption
• Establish a credible and trusted Dyne scientific presence with U.S. KOLs, payers, and patient communities
• Build a scalable, high-performing Medical Affairs organization ready for multiple launches
• Effectively translate scientific and clinical data into strategies that drive both access and lifecycle value
• Establish foundational capabilities and ways of working in a first-launch environment

Enterprise & Launch Leadership

• Own U.S. medical strategy, launch readiness, and execution, with direct accountability for delivering multiple successful product launches from a medical affairs perspective
• Build and develop a strong leadership bench, establishing a leadership team capable of scaling with the organization and future launches
• Serve as a core member of cross-functional launch leadership, shaping enterprise decisions and influencing cross-functional tradeoffs, while resolving complex scientific, medical, and operational balance in a time-critical environment
• Ensure U.S. Medical Affairs capabilities, processes, governance, and resourcing are built and operationalized to support launch and early commercialization
• Represent U.S. Medical Affairs scientific priorities and business needs at the US LT and the GMA LT
• Drive culture intentionally during scale

U.S. Medical Affairs Strategy & Execution

• Define, own, and execute the U.S. Medical Affairs strategy aligned with global medical strategy and enterprise objectives
• Ensure aligned cross-functional strategies, goals, and execution in partnership with US LT
• Translate medical and clinical insights into actionable strategies that support appropriate product adoption, evidence generation, payer confidence, and long-term lifecycle value
• Oversee U.S. medical tactics, including KOL strategy, advisory boards, congresses, medical education, payer engagement, and scientific exchange

Organization Building & People Leadership

• Build, lead, and scale a best-in-class U.S. Medical Affairs organization, including Field Medical (Medical Science Liaisons and Medical Value Liaisons) and home-office medical functions, capable of operating with speed, rigor, and scientific credibility while delivering high impact outcomes in a first-launch setting and preparing for subsequent launches
• Establish clear goals, decision rights, accountability, and performance expectations across the organization
• Develop leadership bench strength, foster a culture of ownership and collaboration, and act as a role model for Dyne's values during a period of rapid organizational growth
• Ensure comprehensive training and learning programs to continuously develop a high performing U.S. Medical Affairs organization

External Engagement & Scientific Leadership

• Serve as Dyne's senior U.S. medical spokesperson to key external stakeholders, including clinical experts, academic leaders, payers, advocacy groups, and other partners
• Shape and optimize treatment paradigms through credible, compliant, and impactful scientific engagement
• Ensure high-quality, fair-balanced medical and scientific exchange across all U.S. external interactions
• Ensure real-time intelligence on competitive data and evolving treatment paradigm

Evidence Generation & Lifecycle Management

• Provide strategic oversight of U.S.-focused evidence generation, ensuring alignment with launch and lifecycle priorities
• Lead cross-functional alignment with Global Medical Affairs, Value & Access, and Clinical Development to ensure integrated evidence generation and launch execution
• Oversee the medical component of product lifecycle management, from launch through early commercialization

Medical Governance & Compliance

• Ensure the highest standards of medical integrity, compliance, and ethical conduct
• Maintain appropriate oversight of non-promotional and promotional medical review processes, ensuring scientific rigor and regulatory compliance while enabling timely launch execution
• Establish scalable medical governance frameworks appropriate for a newly commercial organization

Education and Skills Requirements :

• MD, PhD, Pharm D or other relevant terminal degree
• Rare Disease, and preferably neuromuscular, launch experience
• Experience in leading Medical Affairs teams in the commercialization phase including leadership of field medical teams
• 20+ years of diverse background of professional experience including ten plus (10+) years of Medical Affairs experience plus clinical development/operations knowledge, with in depth knowledge of rare disease drug development, market access, commercialization, and life cycle management
• Experience working with teams / individuals with varied cultural backgrounds and learning styles
• Intermediate to advanced competency and experience with a variety applications, including Microsoft Suite, MS Project, SharePoint, Veeva and/or other related project management tools
• Strong interpersonal skills with the need to work closely with both external and internal business partners
• Excellent communication skills, both written and verbal
• Demonstrated executive presence and the ability to communicate at all levels of the organization and with external stakeholders in various settings including congresses, advocacy, and Boards of Directors
• Ability to travel up to 50% in the U.S. region and internationally at times
• Fluent in English (required)
• Excellent team player, strong decision maker, and ability to work in a matrix environment
• Ability to work independently as a hands-on manager, and proactively contribute as a resource when necessary
• Flexibility to adapt and meet the changing/growing needs of our customers
• High level of integrity, compliance, ethics, and transparency

• Enterprise mindset vs. functional silo
• Builder mentality
• Ability to operate in ambiguity
• Executive influence

MA Pay Range

$196,000 - $285,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief,