Senior Director, Toxicology

Responsibilities

• Develop and execute comprehensive nonclinical safety strategies to support clinical candidate selection, IND-enabling activities, and regulatory submissions
• Provide expert interpretation of toxicology, safety pharmacology, and DART data to inform development decisions
• Lead the design, oversight, and scientific interpretation of outsourced toxicology studies conducted at CRO partners
• Represent toxicology on cross-functional project teams as the primary expert
• Author and review regulatory documents including INDs, IBs, NDAs, and MAAs
• Identify and proactively manage safety-related risks and provide mitigation strategies to senior leadership

Requirements

• PhD in Toxicology, Pharmacology, Molecular or Cell Biology, or a related science
• 10-12 years of industry experience in toxicology and nonclinical drug development post-PhD
• Expert-level knowledge of global preclinical and clinical regulatory guidelines
• Proven experience leading external CROs and multidisciplinary scientific teams
• Demonstrated success working in cross-functional program teams

Preferred Qualifications

• DABT certification
• Experience with targeted delivery approaches, rare disease development, endocrine, or neuromuscular indications

About the Company

Amylyx is a clinical-stage company focused on treating diseases with high unmet needs, including post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).