Amylyx Senior Director of Medical Affairs Operations leads strategic and operational functions for Medical Affairs at Amylyx. Responsible for launch readiness, vendor management, and budget oversight.
Responsibilities
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.
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. 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.
Medical Operations Leadership and Team Building: Build and lead the Medical Affairs Operations function, including defining the organizational structure, capabilities, roles, responsibilities, and operating rhythms required to support growth. Recruit, develop, and retain team members as the function scales, and foster a culture of accountability, collaboration, continuous improvement, and high-quality execution.
Qualification
Bachelor's degree in life sciences10+ years of biotechnologyStrong understanding of UAdvanced degree (MBAWork Location and ConditionsAt Amylyx
Required
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, leading complex cross-functional initiatives, and influencing senior stakeholders in a matrixed organization.
Demonstrated 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 sponsorships 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.
Preferred
Advanced degree (MBA, MPH, PharmD, PhD, or equivalent) preferred.
Experience building operational capabilities within emerging biotech organizations preferred.
Work Location and Conditions
At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska and Hawaii.
You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.
