Jobs at Amylyx

Lead design, development, and QC of SAS programs and CDISC-compliant SDTM/ADaM datasets, produce TFLs, support eCTD regulatory submissions, build integrated safety/efficacy analyses, perform code review/validation, and provide programming support for clinical trials and ad hoc analyses.

Lead operational planning and execution for preclinical R&D programs, managing CROs/vendors, budgets, contracts, study documentation, risk tracking, process improvements, cross-functional coordination, and reporting/dashboards. Support department head with scheduling and ensure programs run on time and inspection-ready.

The Senior Director, Trade & Channel Operations will build and manage the distribution model for product launch, optimizing operational performance and collaboration with various departments.

The Process Engineer will provide technical support for aseptic drug product manufacturing and ensure compliance with GMP standards, lead investigations, and drive continuous improvement initiatives.

The Director of Investor Relations will lead investor engagement, manage communications, prepare regulatory filings, and translate complex information for investors, while collaborating with senior leadership to drive IR strategy.

Lead statistical strategy for clinical development programs from design through regulatory submission. Oversee trial design, analysis plans, CRO/vendor work, regulatory materials, and mentor statisticians. Communicate statistical insights cross-functionally and support regulatory interactions; travel to Cambridge several times yearly.

The Senior Vice President of Sales will build and lead the commercial strategy for a biotechnology company, overseeing product launch readiness, sales organization development, and engagement with key stakeholders.