Senior Director, Toxicology

The role

The Senior Director, Toxicology will support the strategy, design, and execution of nonclinical safety programs. This person will lead toxicology strategy across a pipeline of drug candidates from discovery to clinical phases.

What you will do

• Develop and execute nonclinical safety strategies for multiple programs including small molecules, peptides, protein-based biologics, and anti-sense oligonucleotides.
• Provide expert interpretation of toxicology, safety pharmacology, DART, and related nonclinical data.
• Lead the design, oversight, and scientific interpretation of outsourced toxicology and safety studies at CRO partners.
• Represent toxicology on cross-functional project teams.
• Author and review regulatory documents including INDs, briefing packages, IBs, NDAs, and MAAs.
• Respond to regulator inquiries from health authorities.
• Establish and maintain relationships with external scientific experts, KoLs, and regulatory consultants.
• Manage safety-related risks and provide recommendations to project teams and senior leadership.
• Contribute to portfolio prioritization.
• Serve as sponsor representative for nonclinical study execution at CRO partners.

Required qualifications

• PhD in Toxicology, Pharmacology, Molecular or Cell Biology, or a related science.
• Minimum 10-12 years industry experience in toxicology and nonclinical drug development following completion of PhD or post doc.
• Demonstrated experience developing and executing nonclinical safety strategies.
• Expert-level knowledge of global preclinical and clinical regulatory guidelines.
• Experience authoring, reviewing, and contributing to regulatory submissions and interactions with global health authorities.
• Ability to interpret complex toxicology and nonclinical data.
• Experience leading external CROs, consultants, and multidisciplinary scientific teams.
• Demonstrated success working in cross-functional program teams.
• Strong and independent organizational skills.
• Excellent written, verbal, and presentation abilities.
• Access to a work setting with privacy, reliable internet access, phone, and ability to video conference.

Nice to have

• DABT certification
• Direct experience with targeted delivery approach
• Direct experience with rare disease development
• Direct experience with endocrine and/or neuromuscular indication

Benefits

• Competitive base pay
• Annual performance-based bonuses
• Equity awards
• Comprehensive benefits package

Before you apply

• Unable to hire employees who reside and/or work in Alaska and Hawaii
• Must be able to travel to Cambridge, MA several times a year

About the company

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). The company has a mission to treat diseases with high unmet needs using rigorous science.