Senior Director, Medical Affairs Operations

The role

The Senior Director of Medical Affairs Operations provides strategic and operational leadership for the Medical Affairs organization. This person will build and scale operational infrastructure, processes, systems, and budgets to support a high-performing medical organization.

What you will do

• Develop annual strategic plans, budgets, and governance structures
• Ensure operational readiness for launch-related activities
• Oversee Medical Affairs budgets, forecasting, and financial planning
• Lead selection, contracting, and performance management of vendors
• Lead operational support for evidence-generation activities and investigator-sponsored research
• Develop Medical Affairs KPIs, dashboards, and reporting capabilities
• Lead selection, implementation, and optimization of Medical Affairs systems and technologies
• Partner with Legal, Compliance, and Regulatory Affairs to establish review and governance processes
• Partner with field medical leadership on organizational design and territory planning
• Build and lead the Medical Affairs Operations function and recruit team members

Required qualifications

• Bachelor's degree in life sciences, healthcare, business, or related field
• 10+ years of biotechnology, pharmaceutical, or healthcare industry experience
• Progressively responsible leadership in Medical Affairs Operations
• Success building or scaling capabilities and leading complex cross-functional initiatives
• Expertise in Medical Affairs operations, launch planning, project management, vendor management, budget management, medical compliance processes, medical systems and technologies, and sponsorships and
• Strong understanding of Medical Affairs functions and their interdependencies
• Strong understanding of U.S. requirements and industry standards applicable to Medical Affairs activities, scientific exchange, and Medical Information
• Experience supporting at least one successful U.S. product launch

Nice to have

• Advanced degree (MBA, MPH, PharmD, PhD, or equivalent)
• Experience building operational capabilities within emerging biotech organizations

Benefits

• Competitive base pay
• Annual performance-based bonuses
• Equity awards
• Comprehensive benefits package

Before you apply

• Unable to hire employees who reside and/or work in Alaska and Hawaii
• Must have access to a work setting that enables meeting all role requirements including privacy and reliable internet

About the company

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). The company has a mission to treat diseases with high unmet needs through rigorous science and commitment.