Amylyx Pharmaceuticals

Senior Director, Toxicology

Cambridge, MA · Director

Sponsorship not specifiedDetected 8 days ago

DartRecruitingPharmacologyAnimal StudiesLeadershipCollaborationOrganizational Skills

About the role

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.
Influence the future direction of the pipeline by integrating emerging toxicology science, translational approaches, and regulatory expectations into development strategy.
We anticipate hiring the Senior Director, Toxicology in September 2026**

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.
Lead the design, oversight, and scientific interpretation of outsourced toxicology and safety studies conducted at CRO partners.
Establish and maintain strong relationships with external scientific experts, KoLs, and regulatory consultants to support program objectives.
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.
Serve as sponsor representative for nonclinical study execution at RO partners across the full spectrum of nonclinical study types including DART.
Demonstrated experience developing and executing nonclinical safety strategies to support drug discovery, candidate selection, IND-enabling studies, regulatory submissions, and clinical development.

Minimum experience of 10-12 years industry experience in toxicology and nonclinical drug development following completion of PhD or post doc.
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.
Demonstrated ability to interpret complex toxicology and nonclinical data and translate findings into actionable development strategies.

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks.
Estimated Pay Range
$269,000 - $291,667 USD
Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.

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.
Author and review regulatory documents including INDs, briefing packages, IBs, NDAs, and MAAs, and respond to regulator inquiries from health authorities.
The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity.

If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

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

This listing is sourced directly from Amylyx Pharmaceuticals's careers page and normalized into a canonical job model.