Principal Scientist, Toxicology
BioSpace · Waltham, MA · 3 wk ago
On-siteAnalyst$159k–$195k/yrFull-time
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.
Pay Range
$159,000 - $195,000 USD