Senior Director, Toxicology

About this role

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Opportunity

The Senior Director Toxicology will support the strategy, design, and execution of nonclinical safety programs to aid in the development of drug candidates from IND-enabling studies to market authorization. The candidate will be highly motivated and contribute to a portfolio of projects in partnership with cross-functional R&D teams to support non-clinical safety evaluations and the translation of new therapeutics candidates.

This person will:

• Serve as a toxicology leader across a diverse and expanding pipeline spanning multiple therapeutic areas and drug modalities, shaping nonclinical safety strategy from discovery to IND-enabling and throughout clinical phases.

• Partner closely with Discovery Biology, Bioanalytical and Translational Science, Program Management, Regulatory, Clinical Development, Clinical Operations, and Leadership teams to accelerate advancement of high-impact therapies to patients.

• Build and scale toxicology capabilities with a high collaborative, and science-driven organization where strategic thinking agility, audacious goals, accountability, and scientific excellence are highly valued.

• Drive innovative and fit-for-purpose safety assessment approaches that enable efficient development timelines while maintaining rigorous scientific and regulatory standards.

• Influence the future direction of the pipeline by integrating emerging toxicology science, translational approaches, and regulatory expectations into development strategy.

• Mentor and develop scientific talent while fostering a culture of accountability, collaboration, and continuous learning.

Responsibilities

• Develop and execute comprehensive nonclinical safety strategies to support clinical candidate selection, IND-enabling activities, regulatory submissions, and clinical development across multiple programs including small molecules, peptides, protein-based biologics, anti-sense oligonucleotides.

• Provide independent and expert interpretation of toxicology, safety pharmacology, DART, and related nonclinical data and study types to inform development decisions and risk-benefit assessments.

• Lead the design, oversight, and scientific interpretation of outsourced toxicology and safety studies conducted at CRO partners.

• Represent toxicology on cross-functional project teams, serving as the primary toxicology expert.

• Author and review regulatory documents including INDs, briefing packages, IBs, NDAs, and MAAs, and respond to regulator inquiries from health authorities.

• Establish and maintain strong relationships with external scientific experts, KoLs, and regulatory consultants to support program objectives.

• Ensure toxicology strategy aligns with global regulatory expectations and industry best practices.

• Identify and proactively manage safety-related risks, provide leadership for investigative toxicology as needed, provide clear recommendations and mitigation strategy to project teams and senior leadership.

• Contribute to portfolio prioritization by integrating toxicology risk, development feasibility, and program value considerations.

• Serve as sponsor representative for nonclinical study execution at RO partners across the full spectrum of nonclinical study types including DART.

Required Qualifications

• PhD in Toxicology, Pharmacology, Molecular or Cell Biology, or a related science.

• Minimum experience of 10-12 years industry experience in toxicology and nonclinical drug development following completion of PhD or post doc.

• DABT certification is desirable.

• Demonstrated experience developing and executing nonclinical safety strategies to support drug discovery, candidate selection, IND-enabling studies, regulatory submissions, and clinical development.

• Broad knowledge in field of toxicology, with practical knowledge of pharmaceutical toxicology. Direct experience with targeted delivery approach, rare disease development, endocrine and/or neuromuscular indication is desirable.

• Expert-level knowledge of global preclinical and clinical regulatory guidelines. Experience authoring, reviewing, and contributing to regulatory submissions and interactions with global health authorities.

• Demonstrated ability to interpret complex toxicology and nonclinical data and translate findings into actionable development strategies.

• Highly experienced leading external CROs, consultants, and multidisciplinary scientific teams to successfully deliver nonclinical development objectives.

• Demonstrated success working in cross-functional program teams.

• Strong and independent organizational skills, with excellent written, verbal, and presentation abilities to effectively communicate scientific concepts to diverse audiences including executive leadership.

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, Arizona, Hawaii, Michigan and Tennessee.

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