Senior Scientist, Toxicology

Dyne Therapeutics•Waltham, MA

1d•Onsite

About The Position

The Senior Scientist, Toxicology is a key member of the preclinical development team and is responsible for the 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.

Requirements

PhD with postdoctoral training in toxicology or a related discipline, and or DVM
5+ years of experience, preferably in a biotech or pharmaceutical setting, including hands-on responsibility for toxicology components of regulatory submissions
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