Head of Toxicology

Soufflé Therapeutics is a biotech company focusing on the cell-type specific delivery of genetic medicines. It’s team of driven scientists is making a mark in delivery of oligonucleotides to extrahepatic tissues. We thrive in a purpose-built lab and office space in Watertown. Come and join us in our quest!

Overview

Souffle Therapeutics is seeking a seasoned head of Toxicology to lead the design, strategy, and execution of nonclinical safety and toxicology programs across our discovery and development portfolio. Reporting to the Vice President of Preclinical Development, this individual will provide scientific and strategic oversight for all GLP, and non-GLP toxicology and safety pharmacology studies conducted internally and through CRO partners. This leader will play a pivotal role in advancing programs from discovery through IND and clinical development, ensuring compliance with global regulatory expectations and scientific best practices. In addition to the regulatory Toxicology responsibilities, the candidate will have the opportunity to impact discovery efforts early on and also characterize novel targeted oligonucleotide modalities using investigative toxicology approaches.

Key Responsibilities

• Develop and lead nonclinical toxicology strategies supporting targeted genetic medicines from discovery through regulatory submission.
• Design, oversee, and interpret GLP and non-GLP studies in rodents, NHPs, and other relevant species.
• Partner with CROs to ensure scientific rigor, adherence to timelines, budgets, and GLP standards.
• Lead toxicology risk assessments, mechanism-of-toxicity investigations, and translational safety evaluations to inform clinical development.
• Author and review nonclinical sections of regulatory filings (INDs, CTAs, NDAs/MAAs) and support interactions with FDA, EMA, and other health authorities.
• Serve as the company’s toxicology subject-matter expert on cross-functional teams, influencing strategy and decision-making across R&D functions.
• Maintain up-to-date knowledge of toxicological methodologies, GLP regulations, and evolving ICH/FDA/EMA guidelines.

Qualifications

• 10 years of relevant experience in biologics and/or oligonucleotide biotech/pharmaceutical toxicology, and demonstrated success leading preclinical safety programs and regulatory submissions.
• Expertise across core toxicology disciplines (general, developmental/reproductive, carcinogenicity, safety pharmacology, toxicokinetics).
• Excellent communication skills to interpret toxicological findings and convey risks in the context of the therapeutic need of a disease
• Proven experience managing CRO studies and authoring regulatory documentation.
• Strong understanding of GLP compliance and global regulatory frameworks (FDA, EMA, ICH).
• Excellent communication, leadership, and organizational skills with the ability to thrive in a fast-paced, collaborative biotech environment.
• Experience in genomic medicine or novel therapeutic modalities is highly desirable.

Education

• PhD, DVM, or equivalent in Toxicology, Pharmacology, or related discipline; DABT certification preferred.

At Soufflé Therapeutics, we are intentional about building an equitable culture. How we treat our people is reflective of this focus. We share the pay range for this specific role with the actual base salary reflected in criteria such as job-related knowledge, skills, market factors, and experience:

$232,000 - $295,000 a year annual management bonus equity.

This is an onsite position in Watertown, MA with flexibility as needed for collaboration and external engagements.

We are an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.