Director, Nonclinical and Translational Science

Amylyx Pharmaceuticals•Cambridge, MA

1d•$216,000 - $243,000•Remote

About The Position

The Director, Nonclinical and Translational Science provides strategic and scientific leadership for nonclinical safety and translational programs across Amylyx’s development portfolio. The role leads programs from candidate nomination through IND-enabling development and regulatory submission, and supports translation into first-in-human trials and subsequent clinical development. Working with cross-functional R&D teams, the Director integrates pharmacology, toxicology, biomarker, and clinical insights to establish development strategies, address risks, and guide data-driven decisions. The role also contributes immunology expertise to program design and clinical translation, evaluates external assets and technologies for potential in-licensing, and supports business development due diligence. The Director develops integrated nonclinical plans covering pharmacology, toxicology, immunotoxicology, safety pharmacology, toxicokinetics, bioanalysis, immunogenicity, and translational activities. The role defines translational strategies, interprets nonclinical and emerging clinical data, oversees outsourced studies and external partners, and prepares and reviews nonclinical and translational content for regulatory documents. The Director provides recommendations at program governance and portfolio decision points and mentors colleagues to strengthen organizational capabilities. This is a remote role within the United States, subject to state eligibility restrictions; applicants residing in Alaska or Hawaii are not being considered. The employee must be able to work remotely in a setting with privacy, reliable internet, phone, and video-conferencing access. Travel to the Cambridge, Massachusetts corporate location several times per year and to other company events is expected. Domestic travel may be up to 10–15%. The estimated pay range is $216,000–$243,000 USD.

Requirements

PhD or equivalent in Toxicology, Pharmacology, or a related scientific discipline with at least 9 years of relevant post-degree pharmaceutical or biotechnology experience; or a Master’s degree with at least 12 years of relevant post-degree experience.
Demonstrated leadership of nonclinical development programs from candidate nomination through IND-enabling studies, IND submission, and first-in-human clinical development.
Immunology subject matter expertise supported by hands-on industry experience and/or an immunology degree.
Broad pharmaceutical toxicology expertise and working knowledge of discovery toxicology, safety pharmacology, toxicokinetics, bioanalysis, pathology, and relevant regulatory guidelines.
Experience integrating nonclinical pharmacology, safety, exposure, biomarker, and clinical data to support dose selection, clinical monitoring, and development decisions.
Experience authoring and reviewing nonclinical sections of regulatory submissions; IND experience is required.
Demonstrated ability to select, manage, and oversee CROs and external experts, including study design, monitoring, data review, and issue resolution.
Strong cross-functional leadership, communication, and influencing skills, including the ability to translate complex science into clear recommendations for technical and senior-leadership audiences.
Ability to prioritize, make sound decisions under uncertainty, and solve problems in a fast-paced, collaborative environment.
Ability to travel domestically up to 10–15%.
Ability to work remotely in a setting that enables privacy, reliable internet access, phone access, and video conferencing.
Ability to travel to the Cambridge, Massachusetts corporate location several times a year and attend other company-related events as requested.

Nice To Haves

Experience with NDAs, BLAs, or MAAs.
Immunology degree, if not already supported by hands-on industry experience.

Responsibilities

Lead nonclinical and translational studies for assigned programs from candidate nomination through IND-enabling development and regulatory submission.
Support clinical teams on first-in-human studies and subsequent clinical development.
Develop and maintain integrated nonclinical development plans covering pharmacology, toxicology, immunotoxicology, safety pharmacology, toxicokinetics, bioanalytical, immunogenicity, and translational activities.
Define translational strategies that connect preclinical findings to clinical hypotheses, including dose and exposure projections, biomarker plans, and evidence for early clinical development.
Serve as an immunology subject matter expert on assigned studies and other pipeline programs.
Provide scientific expertise and recommendations at program governance and portfolio decision points, including assessments of risks, data gaps, timelines, and resource needs.
Serve as sponsor representative and monitor for assigned outsourced in vivo and bioanalytical studies; oversee CROs, consultants, toxicology laboratories, and other external partners to ensure studies meet timelines and plans and are rigorous, compliant, and fit for purpose.
Interpret and integrate nonclinical and emerging clinical data to refine program strategy, investigate safety signals, and guide studies supporting 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.
Contribute to evaluation of external opportunities and provide nonclinical and translational due diligence for business development activities.
Mentor and influence colleagues across disciplines, foster rigorous scientific discussion, and strengthen nonclinical and translational capabilities across the organization.
Partner with Pharmacology, Clinical Development, Biomarkers, and other functions to establish integrated development plans.
Represent Nonclinical and Translational Science on cross-functional project teams and proactively address program risks and evidence gaps.
Evaluate external assets and technologies for potential in-licensing opportunities with Business Development and cross-functional subject matter experts.
Provide immunology expertise for program design, strategy, clinical translation, and progression.