Teams at Amylyx

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.

Provide CMC quality oversight for sterile and finished drug product manufacturing, packaging, labeling, distribution and related quality systems. Review and approve validation, batch, QC, stability, change control, CAPA, and regulatory submission (NDA CMC) documents. Support inspections and act as QA SME with internal teams and external contract manufacturers to ensure GMP/GDP compliance.

Lead enterprise commercial training and readiness for customer-facing teams. Design scalable curricula across disease, product, engagement, compliance, and launch readiness; manage vendors and cross-functional partners; measure training impact; establish training infrastructure, governance, and continuous improvement to support a 2027 product launch and future growth.