Director of Medical Affairs Operations & Launch Readiness

amylyx; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Amylyx is a clinical-stage biotechnology company focused on post-bariatric hypoglycemia, Wolfram syndrome, and ALS. We seek a Senior Director of Medical Affairs Operations to design and scale the operational infrastructure, governance, and budgets for a high-performing medical organization.

You will work with cross-functional partners across Commercial, Regulatory, Clinical Development, Pharmacovigilance, Legal/Compliance, Market Access, and IT to ensure launch readiness and scalable operations.

Qualifications

• Bachelor's degree in life sciences, healthcare, business, or related field.
• 10+ years of biotechnology, pharmaceutical, or healthcare industry experience, including progressively responsible leadership in Medical Affairs Operations and demonstrated success building or scaling capabilities.

Responsibilities

• Lead strategic operations for Medical Affairs to support launch readiness and operational excellence.
• Oversee budgets, forecasting, accruals, and vendor governance in collaboration with finance and procurement.
• Develop KPIs, dashboards, and reporting capabilities for Medical Affairs systems and tools.
• Ensure governance and compliance with Legal, Compliance, Regulatory, and other stakeholders.
• Build and scale the Medical Affairs Operations function with a culture of accountability and continuous improvement.

Skills

Medical Affairs Ops

Launch Readiness

Vendor Management

Budget Management

Cross-functional Leadership

KPIs & Analytics

Education

Bachelor's in Life Sciences

Tools

CRM systems

Publication tools

Data dashboards

Job description

Amylyx is a clinical-stage biotechnology company focused on post-bariatric hypoglycemia, Wolfram syndrome, and ALS. We seek a Senior Director of Medical Affairs Operations to design and scale the operational infrastructure, governance, and budgets for a high-performing medical organization.

You will work with cross-functional partners across Commercial, Regulatory, Clinical Development, Pharmacovigilance, Legal/Compliance, Market Access, and IT to ensure launch readiness and scalable operations.