Remote Senior Director, Toxicology & Safety Strategy

Amylyx Pharmaceuticals, Inc.; United States; Remote; USD 240,000 - 360,000; Full time

Job summary

Amylyx is seeking a Senior Director of Toxicology to lead nonclinical safety strategies across our diverse pipeline from IND-enabling studies through clinical development. You will guide safety assessments and interact with regulatory bodies.

You will manage CROs, mentor scientific staff, and collaborate with Discovery Biology, Regulatory, and Clinical teams while traveling periodically to Cambridge, MA.

Qualifications

• PhD in Toxicology, Pharmacology, or related field.
• 10-12+ years experience in nonclinical drug development.
• Experience with targeted delivery, rare diseases, endocrine, or neuromuscular indications preferred.
• Expert knowledge of global regulatory guidelines.
• Proven track record in developing safety strategies and managing CRO collaborations.
• Strong communication and leadership skills.

Responsibilities

• Develop and execute comprehensive safety assessment plans for small molecules, biologics, peptides, and oligonucleotides.
• Interpret complex toxicology data.
• Oversee outsourced safety studies.
• Author and review regulatory submissions including INDs, IBs, NDAs, and MAAs.
• Collaborate with cross-functional teams (Discovery Biology, Regulatory, Clinical, etc.).
• Mentor scientific staff.
• Manage safety risks and investigative toxicology.

Skills

Leadership

Regulatory knowledge

Toxicology data interpretation

CRO management

Team mentoring

Education

PhD in Toxicology or related field

Job description

Amylyx is seeking a Senior Director of Toxicology to lead nonclinical safety strategies across our diverse pipeline from IND-enabling studies through clinical development. You will guide safety assessments and interact with regulatory bodies.

You will manage CROs, mentor scientific staff, and collaborate with Discovery Biology, Regulatory, and Clinical teams while traveling periodically to Cambridge, MA.