Senior Scientist, Toxicology

Dyne Therapeutics • Waltham, MA

1d • $159,000 - $195,000 • 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

Benefits

• 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.
• Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree