Director, Translational & Nonclinical Science

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Hybrid; USD 216,000 - 243,000; Full time

Job summary

Amylyx Pharmaceuticals, Inc. in Cambridge, MA is seeking a Director, Nonclinical and Translational Science to provide strategic and scientific leadership across nonclinical programs from candidate nomination through IND-enabling development and regulatory submission, with translation to first-in-human trials.

You will integrate pharmacology, toxicology, biomarker and clinical insights to define development strategies, mitigate risks, and enable data-driven decisions while collaborating with

Qualifications

• PhD or equivalent in toxicology, pharmacology, or related field with 9+ years post-degree pharma/biotech experience.
• Leadership of nonclinical development programs from nomination to IND-enabling studies and first-in-human development.
• Subject matter expertise in immunology with industry experience.
• Broad knowledge of toxicology, safety pharmacology, toxicokinetics, and regulatory guidelines.
• Experience integrating nonclinical data to support dose selection and clinical strategies.
• IND experience; NDA/BLA/MAA experience desirable.
• Experience managing CROs and external experts.

Responsibilities

• Lead nonclinical and translational studies from nomination to IND-enabling development and regulatory submission.
• Support clinical teams on first-in-human studies and early development.
• Develop integrated nonclinical development plans covering pharmacology, toxicology, and translational activities.
• Define translational strategies linking preclinical findings to clinical hypotheses and dose projections.
• Serve as immunology SME on studies and portfolio programs.
• Oversee CROs and external partners to timelines and study plans.
• Contribute to regulatory content for INDs, NDAs, etc.
• Mentor colleagues and strengthen capabilities across the organization.

Skills

Cross-functional leadership

Immunology expertise

IND submissions

Regulatory strategy

CRO management

Data integration

Education

PhD or equivalent in Toxicology/Pharmacology

Master’s degree with 12+ years post-degree experience

Job description

Amylyx Pharmaceuticals, Inc. in Cambridge, MA is seeking a Director, Nonclinical and Translational Science to provide strategic and scientific leadership across nonclinical programs from candidate nomination through IND-enabling development and regulatory submission, with translation to first-in-human trials.

You will integrate pharmacology, toxicology, biomarker and clinical insights to define development strategies, mitigate risks, and enable data-driven decisions while collaborating with