Role Summary:
The Principal Scientist, Toxicology is responsible for strategic planning and execution of nonclinical safety plans for Dyneβs portfolio programs, supporting late discovery through first-in-human and proof-of-concept clinical studies of investigational antibody oligonucleotide therapeutics to treat serious muscle diseases. Designs, oversees, and critically evaluates exploratory and GLP-compliant toxicology studies; authors and reviews nonclinical regulatory documents; and participates in regulatory authority interactions.
Primary Responsibilities:
- Represent toxicology on program teams, providing expertise from discovery through development.
- Design and execute nonclinical safety plans for candidate therapeutics.
- Serve as the principal contact to external CROs to ensure studies meet quality and regulatory standards (FDA, CHMP, WHO, GLP).
- Interpret toxicology data and communicate results to program teams and senior management.
- Write submission-ready documentation and toxicology content for regulatory submissions.
- Lead issue-resolution teams for investigative and discovery toxicology.
Education and Skills Requirements:
- PhD or equivalent experience; minimum 8+ years related experience.
- Relevant board certification preferred.
- Expertise in nonclinical safety assessment and scientific leadership across development programs.
- Experience designing, managing, and overseeing nonclinical toxicology studies (including CRO work).
- Strong understanding of nonclinical safety regulatory requirements; ensures compliant execution and documentation.
- Proven ability to interpret/critically evaluate toxicology data and author/review high-quality study reports and regulatory documentation.
- Ability to anticipate and address safety/regulatory risks.
- Experience applying/advancing toxicology methods/technologies.
- Plus: toxicity assessment of antibody-drug conjugates and/or oligonucleotide therapeutics; immunology/immunotoxicology.
- Excellent written/verbal communication; collaboration in fast-paced environment managing multiple priorities.