VP, U.S. Medical Affairs
Functional Improvement · Waltham, MA · Yesterday
Healthcare$196k–$285k/yrFull-time
About the role
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.
Primary Responsibilities
- 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
- Define and execute the U.S. medical strategy aligned with global medical strategy and enterprise objectives
- Ensure aligned cross-functional strategies, goals, and execution in partnership with US LT and the GMA LT
- 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
- Maintain appropriate oversight of non-promotional and promotional medical review processes, ensuring scientific rigor and regulatory compliance while enabling timely launch execution
- Ensure the highest standards of medical integrity, compliance, and ethical conduct
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
- 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
- Maintain appropriate oversight of non-promotional and promotional medical review processes, ensuring scientific rigor and regulatory compliance while enabling timely launch execution
Qualifications
- 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 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
Skills
- Builder mentality
- Enterprise mindset vs. functional silo
- Ability to operate in ambiguity
- Executive influence
Pay
$196,000—$285,000 USD