Director, Nonclinical and Translational Science

Required

• PhD or equivalent degree in Toxicology, Pharmacology, or a related scientific discipline with 9+ years of relevant post degree pharmaceutical or biotechnology experience; or a Master’s degree with 12+ years of relevant experience post degree.
• Demonstrated leadership of nonclinical development programs from candidate nomination through IND-enabling studies, IND submission, and first-in-human clinical development.
• Subject matter expertise in immunology, supported by hands industry experience and/or immunology degree.
• Broad expertise in pharmaceutical toxicology and working knowledge of discovery toxicology, safety pharmacology, toxicokinetics, bioanalysis, pathology, and relevant regulatory guidelines.
• Experience integrating nonclinical pharmacology, safety, exposure, biomarker, and clinical data to support dose selection, clinical monitoring, and development decisions.
• Experience authoring and reviewing nonclinical sections of regulatory submissions; IND experience is required, and experience with NDAs, BLAs, or MAAs is desirable.
• Demonstrated ability to select, manage, and oversee CROs and external experts, including study design, monitoring, data review, and issue resolution.
• Strong cross-functional leadership, communication, and influencing skills, with the ability to translate complex science into clear recommendations for technical and senior-leadership audiences.
• Ability to prioritize, make sound decisions under uncertainty, and solve problems effectively in a fast-paced, collaborative environment.
• Ability to travel domestically up to 10–15%.
• 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.