Amylyx Pharmaceuticals

Lead the execution of real-world evidence and health outcomes studies for priority pipeline assets. Develop evidence generation plans and deliver high-quality analytics to inform internal decision-making and product development.

The Senior Director will design and build the U.S. distribution model, including specialty pharmacy and 3PL channels, to support product launch readiness. They will also lead contracting strategies, manage vendor performance, and collaborate cross-functionally to ensure operational excellence.

This role provides strategic medical leadership for late-stage clinical programs, leading the development and execution of Clinical Development Plans (CDPs) by integrating clinical, scientific, regulatory, and commercial considerations. Responsibilities include driving study design, interpreting complex data, serving on cross-functional teams, and leading interactions with external stakeholders like investigators and regulatory agencies.

This role provides enterprise-level leadership and strategic direction for the validation, lifecycle management, and continuous compliance of GxP-relevant computerized systems, with a strong focus on the Veeva Quality Suite. Responsibilities include overseeing quality compliance processes such as Change Control, Deviations, CAPA, and continuous improvement, ensuring timely closure and effective governance.

This role involves leading study-specific design, development, and validation of clinical data capture systems while supporting data management activities across database setup, conduct, and closeout phases. The individual will also lead the development of SAS macros, data listings, summary tables, and visualizations for data review and manage external vendor compliance.