We are a leading mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Using our proprietary mRNA therapeutic platform (MRT), we create mRNA that encodes functional proteins. Our mRNA is delivered to the target cell where the cell’s own machinery recognizes it and translates it, restoring or augmenting protein function to treat or prevent disease.
At Translate Bio, we’re also passionate about our five core values: Put People First, Be Approachable, Act as One, Be Tenacious, and Be Bold. These values embody our culture and underscore our mission to bring mRNA therapeutics to all.
The Senior Scientist, Toxicology reports to the Director, Toxicology and is an integral part of the Translational Sciences group. This position offers will work closely with various functions throughout the company and impact research, development and clinical programs. The primary responsibility of this role is to provide toxicological expert support and guidance on nonclinical safety assessment, ensures regulatory compliance in toxicology study conduct to support discovery and development. This position also offers opportunities to learn and interact with technical development, clinical development, regulatory affair and other functions internally for a variety of therapeutic indications.
- Collaborate with multi-functional teams to provide toxicological support and guidance to research and development programs
- Provide support to multi-functional research project teams to develop optimal strategies to address specific safety issues
- Oversee toxicology study conduct at external Contract Research Organizations (CROs), initiate appropriate processes for contract implementation, study protocol development and timeline optimization
- Monitor toxicology studies, ensure quality and timely execution in line with appropriate quality and regulatory compliance (FDA, ICH and GLP), proactively manage interactions with CROs and facilitate timely issue resolutions
- Summarize and present data at cross-functional meetings or to key internal and external audiences
- Prepare or review non-clinical sections of regulatory documents, including pre-IND or scientific advice briefing documents, IND or CTA, IBs, DSURs, PSURs and other documents; ensures their compliance with various regulatory authorities/guidelines
- Manage and prepare toxicological risk assessments to support manufacturing
- Willing to assume additional responsibilities as assigned
- Work well cross-functionally in a matrix environment
Required Skills & Qualifications
- MS with 5+ year or PhD with 2+ year pharmaceutical/biotech/CRO experience in toxicology
- Experience in development of mRNA therapeutics and immunotoxicology is desired
- Prior experience in working with CROs; design, execution and reporting of GLP toxicology studies
- Ability to travel to manage CRO/vendor collaborations (~10%)
- Familiarity with ICH/FDA guidelines and GLP regulations for the conduct of toxicology studies to support regulatory filings
- Experience in regulatory submissions, including IND/CTA and BLA/NDA is desired
- Excellent organizational and communication skills; ability to cultivate and maintain effective business partner relationships
- Thrives working in a collaborative, team environment