Senior Director, Toxicology

Role: Senior Director of Toxicology leading nonclinical safety strategies for Amylyx's diverse pipeline from IND-enabling studies through clinical development. Responsibilities: develop and execute comprehensive safety assessment plans for small molecules, biologics, peptides, and oligonucleotides; interpret complex toxicology data; oversee outsourced safety studies; author and review regulatory submissions including INDs, IBs, NDAs, and MAAs; collaborate with cross-functional teams (Discovery Biology, Regulatory, Clinical, etc.); mentor scientific staff; and manage safety risks and investigative toxicology. Requirements: PhD in Toxicology, Pharmacology, or related field; 10-12+ years industry experience in nonclinical drug development; experience with targeted delivery, rare diseases, endocrine, or neuromuscular indications preferred; expert knowledge of global regulatory guidelines; proven track record in developing safety strategies and managing CRO collaborations; strong communication and leadership skills. HighValue: experience with IND-enabling studies, regulatory interactions, and safety pharmacology across multiple modalities; ability to influence development strategy and ensure regulatory compliance. WorkSetup: remote within select US states with periodic travel to Cambridge, MA; travel several times annually.