Director, Nonclinical and Translational Science

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. 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.

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.
• Contribute to evaluation of external opportunities and provide nonclinical and translational due diligence in support of business development activities.
• Mentor and influence colleagues across disciplines, foster rigorous scientific discussion, and help strengthen nonclinical and translational capabilities across the organization.

Required Qualifications

• PhD or equivalent degree in Toxicology, Pharmacology, or a related scientific discipline with 9+ years of relevant post degree pharmaceutical or biotechnology experience; or a Master’s degree with 12+ years of relevant experience post degree.
• Demonstrated leadership of nonclinical development programs from candidate nomination through IND-enabling studies, IND submission, and first-in-human clinical development.
• Subject matter expertise in immunology, supported by hands industry experience and/or immunology degree.
• Broad expertise in pharmaceutical toxicology 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, and experience with NDAs, BLAs, or MAAs is desirable.
• 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, with 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 effectively in a fast-paced, collaborative environment.
• Ability to travel domestically up to 10–15%.

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska and Hawaii.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.