Senior Scientist, Toxicology
Dyne Therapeutics
July 02, 2026
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Role Summary:
- Senior Scientist, Toxicology responsible for planning and execution of nonclinical safety plans for Dyne’s portfolio programs, supporting late discovery through first-in-human and proof-of-concept studies.
- 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; provide expertise and guidance from discovery through development.
- Design and execute nonclinical safety plans for candidate therapeutics.
- Serve as principal contact to external CROs to ensure studies follow applicable quality and regulatory standards and guidelines (FDA, CHMP, WHO and 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 and drive investigative and discovery toxicology as needed.
Education and Skills Requirements:
- PhD with postdoctoral training in toxicology (or related discipline) or DVM.
- Relevant board certification preferred.
- 5+ years of experience (biotech/pharma preferred) with hands-on responsibility for toxicology components of regulatory submissions.
- Demonstrated expertise in nonclinical safety assessment and leadership across development programs.
- Experience designing, managing, and overseeing nonclinical toxicology studies (including at CROs).
- Strong understanding of nonclinical safety regulatory requirements; ensure compliant execution and documentation.
- Ability to interpret/critically evaluate toxicology data and author/review high-quality reports and regulatory documentation.
- Ability to anticipate, assess, and address nonclinical safety and regulatory risks.
- Experience applying/advancing toxicological methods, technologies, or approaches.
- Plus: experience with toxicity of antibody-drug conjugates and/or oligonucleotide-based therapeutics; immunology/immunotoxicology expertise.
- Excellent written/verbal communication; able to work collaboratively in a fast-paced environment managing multiple priorities.
- Senior Scientist, Toxicology responsible for planning and execution of nonclinical safety plans for Dyne’s portfolio programs, supporting late discovery through first-in-human and proof-of-concept studies.
- 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; provide expertise and guidance from discovery through development.
- Design and execute nonclinical safety plans for candidate therapeutics.
- Serve as principal contact to external CROs to ensure studies follow applicable quality and regulatory standards and guidelines (FDA, CHMP, WHO and 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 and drive investigative and discovery toxicology as needed.
Education and Skills Requirements:
- PhD with postdoctoral training in toxicology (or related discipline) or DVM.
- Relevant board certification preferred.
- 5+ years of experience (biotech/pharma preferred) with hands-on responsibility for toxicology components of regulatory submissions.
- Demonstrated expertise in nonclinical safety assessment and leadership across development programs.
- Experience designing, managing, and overseeing nonclinical toxicology studies (including at CROs).
- Strong understanding of nonclinical safety regulatory requirements; ensure compliant execution and documentation.
- Ability to interpret/critically evaluate toxicology data and author/review high-quality reports and regulatory documentation.
- Ability to anticipate, assess, and address nonclinical safety and regulatory risks.
- Experience applying/advancing toxicological methods, technologies, or approaches.
- Plus: experience with toxicity of antibody-drug conjugates and/or oligonucleotide-based therapeutics; immunology/immunotoxicology expertise.
- Excellent written/verbal communication; able to work collaboratively in a fast-paced environment managing multiple priorities.