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 Director, Nonclinical and Translational Science will provide strategic and scientific leadership for nonclinical and translational programs across the development portfolio. This individual will lead programs from candidate nomination through IND-enabling development, regulatory submission, and translation into first-in-human clinical trials and beyond. Working closely with cross-functional R&D teams, the Director will integrate pharmacology, toxicology, biomarker, and clinical insights to define development strategies, identify and mitigate risks, and enable data-driven decisions that advance novel therapeutics for patients.

This person will also:

Provide strategic and scientific leadership for nonclinical safety and translational science, informing portfolio decisions, development strategy, and regulatory interactions.
Partner with Pharmacology, Clinical Development, Biomarkers, and other functions to establish integrated plans that connect mechanism, exposure, pharmacodynamic activity, safety, and clinical translation.
Represent Nonclinical and Translational Science on cross-functional project teams, providing clear recommendations and proactively addressing program risks and evidence gaps.
Evaluate external assets and technologies for potential in-licensing opportunities in partnership with Business Development and cross-functional subject matter experts.
Provide expertise in Immunology concepts, application to program design and strategy, and clinical translation and progression.

Responsibilities

Lead nonclinical and translational studies for assigned programs from candidate nomination through IND-enabling development, regulatory submission.
Support the clinical teams on first-in-human studies and subsequent clinical development.
Develop and maintain integrated nonclinical development plans, including pharmacology, toxicology, immunotoxicology, safety pharmacology, toxicokinetics, bioanalytical, immunogenicity, and translational activities aligned with program objectives and regulatory expectations.
Define translational strategies that connect preclinical findings to clinical hypotheses, including data to support dose and exposure projections, biomarker plans, and evidence needed to support early clinical development.
Serve as immunology subject matter expert on assigned studies and other pipeline programs across the portfolio.
Provide scientific subject matter expertise in nonclinical development and immunology with clear recommendations at program governance and portfolio decision points, including assessment of risks, data gaps, timelines, and resource needs.
Serve as CRO sponsor representative and monitor for outsourced in vivo studies and bioanalytical studies as assigned, and hold accountable CROs, consultants, toxicology laboratories, and other external partners to timelines and study plans; ensure studies are scientifically rigorous, timely, compliant, and fit for purpose.
Interpret and integrate nonclinical and emerging clinical data to refine program strategy, investigate safety signals, and guide studies that support continued clinical development and registration.
Lead preparation and review of nonclinical and translational content for regulatory documents, including briefing books, INDs, Investigator’s Brochures, NDAs, BLAs, and MAAs.