Senior Manager, U.S. Medical Affairs Operations

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