Senior Director, Medical Affairs Operations at Amylyx Pharmaceuticals in Cambridge, MA

Job description

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Opportunity The Senior Director of Medical Affairs Operations will provide strategic and operational leadership for the Medical Affairs organization. This individual will be responsible for building and scaling the medical affairs operational infrastructure, processes, systems, governance, vendor ecosystem, budgets, and performance metrics necessary to support a high-performing and compliant medical organization. Working closely with Medical Affairs leadership and cross-functional partners across Commercial, Regulatory Affairs, Clinical Development, Pharmacovigilance, Legal/Compliance, Market Access, and IT, the Senior Director will ensure operational launch readiness while establishing a foundation that can scale as the organization grows. The successful candidate will be a proactive leader with deep expertise in medical affairs operations, launch planning, project management, vendor oversight, and process optimization in a fast-paced biotechnology environment. Responsibilities Medical Affairs Strategic Operations: Partner with Medical Affairs leadership to develop annual strategic plans, budgets, resource and operating models, leadership team meeting agendas and governance structures, and organizational priorities to support launch readiness and operational excellence and efficiency. Launch Readiness and Execution: Ensure operational readiness for launch-related activities, including field medical effectiveness, medical information, publication and scientific communications, KOL engagement, and congress execution. Vendor and Budget Management: Oversee Medical Affairs budgets, forecasting, accruals, and financial planning. Partner with Finance and Procurement to optimize vendor and spending strategies. Lead selection, contracting, governance, and performance management of Medical Affairs vendors and strategic partners. Evidence Generation/Investigator-Initiated Research: Lead operational support for evidence-generation activities, including investigator-sponsored research, grants, collaborative research, and other applicable Medical Affairs studies. Establish governance, intake and review processes, contracting workflows, fair-market-value and budget coordination, milestone tracking, reporting, issue escalation, and closeout processes in partnership with relevant cross-functional stakeholders. Systems, Technology, and Analytics: Develop Medical Affairs KPIs, dashboards, and reporting capabilities. Lead the selection, implementation, and optimization of Medical Affairs systems and technologies, including CRM platform, Medical Information systems, publication and scientific communication tools, and grant and investigator-initiated study systems and processes. Compliance and Governance: Partner closely with Legal, Compliance, and Regulatory Affairs to establish appropriate review and governance processes. Develop and maintain documentation, SOPs, training programs, and operational controls. Field Medical Operations: Partner with field medical leadership on organizational design, territory planning, stakeholder segmentation and prioritization, CRM utilization, operational processes, and field-effectiveness metrics. De