Principal Scientist, Toxicology

Dyne Therapeutics • Waltham, MA

5h • Onsite

About The Position

The Principal Scientist, Toxicology is a key member of preclinical development teams at Dyne Therapeutics, a company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. Dyne Therapeutics is developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease, advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. This role 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 Principal Scientist applies an in-depth understanding of regulatory guidance related to nonclinical development and designs, oversees, and critically evaluates exploratory and GLP-compliant toxicology studies. Additionally, the role involves authoring and reviewing nonclinical regulatory documents and participating in interactions with regulatory authorities. This is a full-time position based in Waltham, MA.

Requirements

• PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience.
• 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.
• 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.

Nice To Haves

• Relevant board certification preferred.
• Experience assessing toxicity of antibody-drug conjugates and or oligonucleotide-based therapeutics is a plus.
• Expertise in immunology or immunotoxicology is a plus.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree
• Number of Employees: 11-50 employees