Senior Director, Medical Affairs Operations

Amylyx Pharmaceuticals•Cambridge, MA

1d•Remote

About The Position

The Senior Director of Medical Affairs Operations will provide strategic and operational leadership for Amylyx’s Medical Affairs organization. This person will build and scale the operational infrastructure, processes, systems, governance, vendor ecosystem, budgets, and performance metrics needed to support a high-performing, compliant medical organization. Working with Medical Affairs leadership and cross-functional partners, the role will ensure operational launch readiness and establish a foundation that can scale with the company. The position includes building and leading the Medical Affairs Operations function, defining its structure and capabilities, and recruiting, developing, and retaining team members. The role supports Medical Affairs strategic planning, launch readiness, field medical operations, evidence generation, vendor and budget management, systems and analytics, and compliance governance. Amylyx supports remote work within the United States, subject to state eligibility restrictions; employees are expected to travel to the Cambridge, Massachusetts corporate location several times a year and attend other company events as needed. The remote work setting must support privacy, reliable internet and phone access, and video conferencing. The estimated pay range is $281,000–$316,000 USD, with final compensation varying based on experience, skills, qualifications, and internal equity.

Requirements

Bachelor’s degree in life sciences, healthcare, business, or a related field.
10+ years of biotechnology, pharmaceutical, or healthcare industry experience.
Progressively responsible leadership in Medical Affairs Operations, with demonstrated success building or scaling capabilities, leading complex cross-functional initiatives, and influencing senior stakeholders in a matrixed organization.
Expertise in Medical Affairs operations, launch planning and execution, project and portfolio management, vendor management, budget management, medical compliance processes, medical systems and technologies, and sponsorship and grants systems and processes.
Strong understanding of Medical Affairs functions and their interdependencies, including Field Medical, Medical Information, Scientific Communications and Publications, Medical Education, Evidence Generation, Investigator-Sponsored Research, Grants, Congresses, KOL Engagement, and Medical Insights.
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, with direct responsibility for one or more Medical Affairs launch workstreams and demonstrated ownership of cross-functional planning, execution, and readiness assessment.
Ability to work in a remote setting that supports privacy, reliable internet and phone access, and video conferencing.
Must be able to travel to the Cambridge, MA corporate location several times a year and attend other company-related events as needed.

Nice To Haves

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

Responsibilities

Partner with Medical Affairs leadership on annual strategic plans, budgets, resource and operating models, leadership meeting agendas, governance structures, and organizational priorities.
Ensure operational readiness for launch activities, including field medical effectiveness, medical information, publications and scientific communications, KOL engagement, and congress execution.
Oversee Medical Affairs budgets, forecasting, accruals, and financial planning; work with Finance and Procurement on vendor and spending strategies.
Lead vendor and strategic partner selection, contracting, governance, and performance management.
Lead operational support for evidence-generation activities, including investigator-sponsored research, grants, collaborative research, and other 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 for evidence-generation activities.
Develop Medical Affairs KPIs, dashboards, and reporting capabilities.
Lead selection, implementation, and optimization of Medical Affairs systems and technologies, including CRM, Medical Information, publication and scientific communication, grant, and investigator-initiated study systems.
Partner with Legal, Compliance, and Regulatory Affairs to establish review and governance processes; develop and maintain documentation, SOPs, training programs, and operational controls.
Partner with field medical leadership on organizational design, territory planning, stakeholder segmentation and prioritization, CRM utilization, operational processes, and field-effectiveness metrics.
Develop and maintain a medical insights framework to capture, analyze, synthesize, communicate, and track the use of field and external stakeholder insights in Medical Affairs strategy, evidence generation, and launch planning.
Build and lead the Medical Affairs Operations function, defining organizational structure, capabilities, roles, responsibilities, and operating rhythms.
Recruit, develop, and retain team members, fostering accountability, collaboration, continuous improvement, and high-quality execution.