Director, Nonclinical and Translational Science

Amylyx Pharmaceuticals•Cambridge, MA

21h•Remote

About The Position

The Director, Nonclinical and Translational Science provides strategic and scientific leadership for nonclinical 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 clinical trials and subsequent development. Working with cross-functional R&D teams, the Director integrates pharmacology, toxicology, biomarker, and clinical insights to define development strategies, identify and mitigate risks, and support data-driven decisions. The Director partners with functions including Pharmacology, Clinical Development, and Biomarkers to develop integrated plans connecting mechanism, exposure, pharmacodynamic activity, safety, and clinical translation. The role represents Nonclinical and Translational Science on project teams, contributes expertise in immunology, evaluates external assets and technologies for potential in-licensing, and provides nonclinical and translational due diligence for business development. The position is remote within the United States, subject to state eligibility restrictions; employees must travel to the company’s Cambridge, Massachusetts corporate location several times a year and attend other company events as needed. Domestic travel of up to 10–15% is expected. The role requires a remote work setting with privacy, reliable internet, phone access, and video-conferencing capability. 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%.
Access to a remote work setting that enables privacy, reliable internet access, phone use, and video conferencing.

Nice To Haves

Experience with NDAs, BLAs, or MAAs is desirable.

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 connecting 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 nonclinical development and immunology expertise and recommendations at program governance and portfolio decision points, including assessments of risks, data gaps, timelines, and resource needs.
Represent the company as sponsor and monitor for assigned outsourced in vivo and bioanalytical studies; hold CROs, consultants, toxicology laboratories, and other external partners accountable to timelines and study plans.
Ensure outsourced 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 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.