Senior Manager, U.S. Medical Affairs Operations
Dyne Therapeutics
4 months ago
Remote friendly (Waltham, MA)
United States
Medical Affairs
Role: Senior Manager, U.S. Medical Affairs Operations (Waltham, MA; not fully remote)
Primary Responsibilities
Field Medical Operations
- Serve as the primary operational partner to the U.S. Field Medical team; plan, execute, and track field medical activities.
- Manage onboarding, offboarding, and ongoing enablement tools (e.g., systems access, training coordination, field resources).
- Lead 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 on monthly dashboards, KPIs, activity metrics, and performance reporting.
Launch & Post-Launch Readiness
- Provide operational leadership for U.S. Medical launch planning (timelines, cross-functional coordination, resourcing, workstream tracking).
- Support Medical Directors and Field Teams with execution of 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 (SOPs, workflows, training documentation).
- Align with Medical Affairs leadership on budget management, forecasting, and expense tracking.
- Manage contracting processes, including Fair Market Value (FMV) assessments.
- Support advisory boards, scientific and payor engagements, and other Medical initiatives.
- Coordinate U.S. Medical leadership meetings, priorities, and strategic planning.
- Serve as a liaison between U.S. Medical Affairs and cross-functional teams (Medical, Commercial, Clinical Development, Regulatory, Compliance, Legal, IT).
Systems, Tools & Compliance
- Oversee operational governance of Medical Affairs systems (Veeva CRM, insights management, content workflows, field enablement tools).
- Ensure compliant processes aligned with medical/promotional review guidelines, industry regulations, and internal SOPs.
- Support generation of reports, dashboards, and data insights for operational decision-making.
Education & Qualifications
- Bachelor’s degree in life science or related discipline (required).
- 5+ years in pharmaceutical/biotech industry (rare disease or accelerated approval launch experience preferred).
Skills/Experience
- Strong organizational and project management skills; ability to drive timelines, adapt to changing priorities, and maintain attention to detail.
- Effective communication and interpersonal skills; ability to lead cross-functional initiatives and manage external partnerships.
- Experience with Veeva Systems, insights platforms, and FMV tools.
- Experience in data analysis and performance tracking.
- Knowledge of compliance, regulatory, and legal frameworks in medical affairs operations.
- Ability to manage multiple complex programs independently in a fast-paced environment.
- Strategic thinking; balance scientific, regulatory, and business considerations.
- Exceptional written and verbal communication.
- Ability to influence cross-functional stakeholders without direct authority.
- Highly collaborative, quality- and compliance-focused, proactive and resilient.
Compensation
- MA pay range: $147,000 - $180,000 USD
Primary Responsibilities
Field Medical Operations
- Serve as the primary operational partner to the U.S. Field Medical team; plan, execute, and track field medical activities.
- Manage onboarding, offboarding, and ongoing enablement tools (e.g., systems access, training coordination, field resources).
- Lead 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 on monthly dashboards, KPIs, activity metrics, and performance reporting.
Launch & Post-Launch Readiness
- Provide operational leadership for U.S. Medical launch planning (timelines, cross-functional coordination, resourcing, workstream tracking).
- Support Medical Directors and Field Teams with execution of 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 (SOPs, workflows, training documentation).
- Align with Medical Affairs leadership on budget management, forecasting, and expense tracking.
- Manage contracting processes, including Fair Market Value (FMV) assessments.
- Support advisory boards, scientific and payor engagements, and other Medical initiatives.
- Coordinate U.S. Medical leadership meetings, priorities, and strategic planning.
- Serve as a liaison between U.S. Medical Affairs and cross-functional teams (Medical, Commercial, Clinical Development, Regulatory, Compliance, Legal, IT).
Systems, Tools & Compliance
- Oversee operational governance of Medical Affairs systems (Veeva CRM, insights management, content workflows, field enablement tools).
- Ensure compliant processes aligned with medical/promotional review guidelines, industry regulations, and internal SOPs.
- Support generation of reports, dashboards, and data insights for operational decision-making.
Education & Qualifications
- Bachelor’s degree in life science or related discipline (required).
- 5+ years in pharmaceutical/biotech industry (rare disease or accelerated approval launch experience preferred).
Skills/Experience
- Strong organizational and project management skills; ability to drive timelines, adapt to changing priorities, and maintain attention to detail.
- Effective communication and interpersonal skills; ability to lead cross-functional initiatives and manage external partnerships.
- Experience with Veeva Systems, insights platforms, and FMV tools.
- Experience in data analysis and performance tracking.
- Knowledge of compliance, regulatory, and legal frameworks in medical affairs operations.
- Ability to manage multiple complex programs independently in a fast-paced environment.
- Strategic thinking; balance scientific, regulatory, and business considerations.
- Exceptional written and verbal communication.
- Ability to influence cross-functional stakeholders without direct authority.
- Highly collaborative, quality- and compliance-focused, proactive and resilient.
Compensation
- MA pay range: $147,000 - $180,000 USD