Role Summary:

The Senior Manager, U.S. Medical Affairs Operations plays a critical role in enabling the success of the U.S. Medical Affairs organization as Dyne prepares for commercial launch and post‑launch execution. This role serves as an operational partner to the U.S. field medical teams (MSLs and MVLs) and U.S. Medical Directors, ensuring operational excellence, compliant processes, and seamless coordination across Medical initiatives. The person in this role brings strong project management skills, experience supporting field medical or medical affairs teams, and the ability to operate in a fast‑paced, high‑growth environment. 

This role is based in Waltham, MA without the possibility of being fully remote.

Primary Responsibilities Include:

Field Medical Operations 

• Serve as the primary operational partner to the U.S. Field Medical team, ensuring effective planning, execution, and tracking of field medical activities.
• Manage onboarding, offboarding, and ongoing enablement tools for field teams (e.g., systems access, training coordination, field resources).
• Lead the coordination, maintenance, and operational execution of the U.S. Medical training curriculum.
• Oversee field medical platforms and systems (e.g., Veeva Systems, insights platforms, territory alignment tools).
• Partner with Field Medical leadership to support monthly dashboards, KPIs, activity metrics, and performance reporting.

 Launch & Post Launch Readiness 

• Provide operational leadership across U.S. Medical launch planning, including timelines, cross-functional coordination, resourcing, and workstream tracking.
• Support Medical Directors and Field Teams with execution of key launch deliverables (e.g., medical education materials, advisory boards, congress planning, scientific exchange tools). 

 General Medical Affairs Operations Support 

• Drive process development and continuous improvement across U.S. Medical Affairs, including SOPs, workflows, and training documentation.
• Maintain alignment with Medical Affairs leadership on budget management, forecasting, and expense tracking for U.S. Medical activities.
• Manage contracting processes for the U.S. Medical Affairs team, including Fair Market Value (FMV) assessments and coordination with relevant internal partners.
• Support development and execution of advisory boards, scientific and payor engagements, and other Medical initiatives.
• Support coordination of U.S. Medical leadership meetings, priorities, and strategic planning sessions.
• Serve as a key liaison between U.S. Medical Affairs and cross-functional groups including Medical, Commercial, Clinical Development, Regulatory, Compliance, Legal, and IT. 

 Systems, Tools & Compliance 

• Oversee operational governance of Medical Affairs systems, including Veeva CRM, insights management, content workflows, and field enablement tools.
• Ensure compliant processes consistent with medical and promotional review guidelines, industry regulations, and internal SOPs.
• Support generation of reports, dashboards, and data insights to drive operational decision making. 

 Education and Skills Requirements:

• Bachelor’s degree in life science or related discipline is required.
• 5+ years of experience in the pharmaceutical or biotechnology industry, with experience supporting rare disease or accelerated approval launches preferred. 
• Strong organizational and project management skills, with the ability to drive timelines, meet firm deadlines, adapt quickly to changing priorities, and maintain attention to detail. Effective communication and interpersonal skills, with a proven ability to lead cross-functional initiatives and manage external partnerships.
• Experience with medical systems such as Veeva Systems, insights platforms and Fair Market Value (FMV) tools.
• Experience in data analysis and performance tracking.
• Knowledge of compliance, regulatory, and legal frameworks in medical affairs operations.
• Proven ability to independently manage multiple complex programs in a fast-paced, dynamic environment.
• Strong strategic thinking skills with the ability to balance scientific, regulatory, and business considerations.
• Exceptional written and verbal communication skills.
• Demonstrated ability to influence cross-functional stakeholders without direct authority.
• Highly collaborative team player with a strong cross-functional mindset.
• Meticulous attention to detail with a commitment to quality and compliance.
• Positive, proactive, and resilient team member who embodies Dyne’s Core Values. 
• Passion for Dyne’s mission and excitement about contributing to the advancement of therapies for patients with serious diseases. 

#LI-Onsite

Role Summary:

The US Medical Director of Medical Affairs leads Dyne’s medical strategy and execution within the United States, focusing on launch readiness, US-specific KOL engagement, congress planning and execution, and supports real-world evidence (RWE) initiatives. This role ensures alignment with global strategy while tailoring activities to US regulatory, payer, and healthcare landscapes. This role leads efforts to communicate and disseminate scientific and clinical information, engage with medical professionals in the field and contribute to the overall success of the company’s portfolio. The US Medical Director collaborates closely with Global Medical Affairs, US Commercial, Regulatory, Market Access, and Clinical teams to drive successful product introduction and lifecycle management in the US market.  

This role is located in our Waltham, MA office.

Primary Responsibilities Include: 

• Develop and execute US Medical Affairs strategy aligned with global objectives and US market needs 
• Act as point person for all US Medical Affairs launch readiness activities, including working closely with global medical director and scientific communications on development of scientific platform development, local congress planning, and local medical education programs 
• Support congress strategy execution in the US, including booth activities, symposia, and scientific presentations 
• Work closely and with the Head of the Medical Science Liaison (MSL) team on US KOL engagement strategy: identify, map, and build relationships with key US experts 
• Support insight collection and synthesis, and supporting the development of field material, working with the MSL team 
• Develop US Medical Affairs advisory board strategy and organize and execute advisory boards and expert panels 
• Work collaboratively with HCP and Patient Marketing as well as cross-functional stakeholders to integrate medical perspectives into brand strategy, ensuring alignment with scientific and commercial objectives 
• Partner with Clinical Development and Clinical Operations to support US trial site engagement and recruitment strategies 
• Working with the Global Medical Director, identify opportunities to generate real-world evidence (RWE) and phase IV data to address data gaps and support HCP and payer treatment decisions 
• Ensure compliance with US regulatory and legal requirements for all medical activities 
• Serve as subject matter expert on neuromuscular diseases and Dyne’s therapeutic platforms for US stakeholders 
• Support the review and approval of externally presented materials through the Medical Review committee and Promotional Review Committee  
• Act as a role model for integrity and compliance in all interactions 

Education and Skills Requirements: 

• Doctorate degree (MD, PhD, PharmD) with experience in rare diseases; neuromuscular experience preferred 
• Minimum 8 years of relevant experience in Medical Affairs within the US pharmaceutical/biotech industry 
• Proven ability to lead US launch readiness and medical strategy execution 
• Excellent communication and relationship-building skills with US KOLs and cross-functional teams 
• Ability to interpret and communicate complex scientific data to diverse audiences 
• Effective communication skills (written, verbal and presentation) 
• Must be willing to travel up to 30%, inclusive of overnight and occasional weekends to meet with customers, internal stakeholders and attend relevant conferences  
• Candidates must be authorized to work in the U.S. 
• Positive team member who embodies Dyne’s Core Values 
• Excitement about Dyne’s vision and mission  
• Experience managing direct reports  

Role Summary:

The Medical Science Liaison (MSL) is an experienced field medical expert who plays a strategic role on the field medical team with depth and breadth of business acumen, therapeutic knowledge and serves as an informal leader on the team. The person in this role is a customer facing, field-based extension of our Medical Affairs team. The MSL’s key objective is to create impact through advancing clinical practice within the assigned territory that leads to improved patient outcomes. This individual serves as a key scientific resource, engaging with healthcare professionals (HCPs), key opinion leaders (KOLs), and other stakeholders to provide scientific and clinical support for our portfolio.  

This is a field-based role.

Primary Responsibilities Include: 

• Builds awareness of the company within the medical community and develops strategic KOL/territory engagement plans aligned with the medical strategy  

• Supports clinical research (investigator-initiated and company-sponsored), speaker development, and training as needed  

• Demonstrates thorough knowledge of the company, its investigational products, and current medical research  

• Maximizes attendance at national and regional conferences to gather insights, assess the competitive landscape, and strengthen relationships  

• Collaborates cross-functionally (clinical, regulatory, market access) to advance business and scientific goals 

• Develops and executes regional medical strategies in alignment with company goals 

• Leads KOL engagement strategies and identifying new scientific leaders 

• Demonstrates business acumen within therapeutic area and understands broader organization and competitive landscape 

• Leads identification and mapping of key KOLs within the therapeutic area, driving engagement strategies 

• Provides strategic leadership within the MSL team as a peer leader, motivator, and problem solver 

• Manages top-tier KOL relationships, synthesizes high-level medical insights, and informs company medical strategies 

• Mentors junior MSLs and contributes to team strategy development 

• Acts as a subject matter expert for internal stakeholders, including marketing, sales, and clinical teams 

• Collaborates with internal teams (HEOR, access, marketing, sales) to maintain a customer-centric, compliant approach within assigned territory 

• Establishes and develops HCP relationships, engaging in activities such as data discussions, clinical trials, and addressing patient journey barriers 

• Responds to unsolicited information requests in a timely, accurate, and compliant manner 

• Ensures compliant dissemination of scientific and clinical information to healthcare providers 

• Manages administrative tasks (e.g., Veeva CRM, expense reports, compliance modules) efficiently, including customer profiling and keeping CRM information up to date 

Education and Skills Requirements: 

• Advanced scientific degree or equivalent required (e.g., MD, PhD, NP, PharmD, PA) 

• 10+ years of MSL experience is preferred

• Clinical experience within neuromuscular disorders (e.g., DMD, DM1) preferred; rare disease experience considered 

• Strong knowledge of investigational products and the neuromuscular space, including emerging data 

• In-depth understanding of clinical trial and investigator-sponsored study processes 

• Proven ability to work effectively within multidisciplinary teams 

• Clear understanding of MSL role and responsibilities 

• Skilled in building and maintaining relationships with KOLs through scientific expertise and follow-through 

• Ability to communicate research results clearly to diverse audiences 

• Strong communication skills (written, verbal, presentation) for building relationships with colleagues 

• Ability to influence without authority at all levels of the organization and externally  

• Expert in planning, prioritizing, and executing tasks efficiently 

• Capable of working independently and managing time in a home office 

• Adaptable in ambiguous and dynamic environments 

• Leverages past neuromuscular relationships to support study enrollment and site communication 

• Experienced in relationship building to expand company reach 

• Experience with relationship building and expanding a company’s reach 

• Must be willing to travel extensively and occasionally on weekends 

• Positive team member who embodies the Dyne Core Values 

• Excitement about Dyne’s vision and mission  

• Must be willing to travel extensively and occasionally on weekends