Role Summary:The Principal Scientist, Toxicology is a key member of preclinical development teams and is responsible for the strategic planning and execution of nonclinical safety plans for Dyne's 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. The role applies an in-depth understanding of regulatory guidance related to nonclinical development and designs, oversees, and critically evaluates exploratory and GLP-compliant toxicology studies. The Principal Scientist authors and reviews nonclinical regulatory documents and participates in interactions with regulatory authorities.
This is a full-time position based in Waltham, MA
Primary Responsibilities:- Represent toxicology on program teams, providing expertise and guidance from discovery through development.
- Design and execute nonclinical safety plans for Dyne candidate therapeutics.
- Serve as the principal contact to external CROs executing these studies, ensuring studies are conducted in line with the appropriate 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 appropriate toxicology content of regulatory submissions.
- Lead issue-resolution teams, driving the science for investigative and discovery toxicology as needed.
Education and Skills Requirements:- PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience.
- Relevant board certification preferred.
- Demonstrated expertise in nonclinical safety assessment and the ability to provide scientific leadership across development programs.
- Experience designing, managing, and overseeing nonclinical toxicology studies, including work conducted at contract research organizations.
- Strong understanding of regulatory requirements governing nonclinical safety, with experience ensuring compliant study execution and documentation.
- Proven ability to interpret and critically evaluate toxicology data and author or review high-quality study reports and regulatory documentation.
- Ability to anticipate, assess, and address nonclinical safety and regulatory risks in complex development environments.
- Experience applying or advancing toxicological methods, technologies, or approaches.
- Experience assessing toxicity of antibody-drug conjugates and or oligonucleotide-based therapeutics is a plus.
- Expertise in immunology or immunotoxicology is a plus.
- Excellent written and verbal communication skills, with the ability to communicate complex scientific concepts to cross-functional stakeholders.
- Demonstrated ability to work effectively in a collaborative, fast-paced environment while managing multiple priorities and timelines.
#LI-Onsite
MA Pay Range
$159,000-$195,000 USD
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
