Senior Manager, U.S. Medical Affairs Operations
Dyne TherapeuticsAbout the role
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. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
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,
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