Position overview
At Tract Bio, our research integrates stem cell biology, cancer biology, regenerative medicine, and precision drug discovery to uncover the mechanisms that drive disease and tissue repair. The company uses its StemEcho™ platform and advanced stem cell models, genomic profiling, gene editing, and translational biology approaches to identify disease-driving cell populations and translate those findings into precision therapies for oncology and chronic disease programs.
The toxicologist will provide strategic leadership for IND-enabling toxicology programs, with primary responsibility for designing and executing nonclinical safety studies, interpreting toxicology datasets, preparing regulatory submissions, and advancing therapeutic candidates from preclinical development through IND filing. This role requires strong expertise in regulatory toxicology, cross-functional collaboration, and the ability to interface with CROs, regulatory agencies, and internal stakeholders.
Key Responsibilities
- Lead the design, execution, and interpretation of IND-enabling toxicology studies, including dose range-finding, GLP toxicology, safety pharmacology, toxicokinetic, and genotoxicity studies.
- Develop comprehensive nonclinical development strategies aligned with regulatory requirements (FDA, EMA) and guide preclinical candidates toward IND submission.
- Serve as the toxicology lead on cross-functional project teams, partnering with CMC, pharmacology, clinical development, and regulatory affairs to ensure alignment across the development timeline.
- Oversee and manage relationships with external CROs conducting toxicology studies, including protocol development, study monitoring, data review, and quality oversight.
- Interpret toxicology data from in vitro and in vivo studies, assess safety margins, and provide strategic recommendations on dose selection, formulation optimization, and risk mitigation strategies.
- Author toxicology sections of regulatory documents including IND submissions, briefing books, investigators' brochures, and responses to regulatory agency questions.
- Represent the toxicology function in interactions with regulatory agencies (e.g., FDA pre-IND meetings, IND submissions) and provide toxicology expertise during due diligence, partnerships, and scientific advisory board meetings.
- Design and implement on PDC-specific toxicology strategies, including payload-driven toxicity, linker stability, on-target/off-tumor effects, species selection and translational relevance
- Ensure toxicology studies are conducted in compliance with GLP, FDA guidelines (ICH, FDA guidance documents), animal welfare regulations, and internal quality standards.
Qualifications
- Ph.D., D.V.M., or equivalent in Toxicology, Pharmacology, or related discipline
- 5+ years of industry experience in nonclinical toxicology (pharma, biotech, or CRO)
- Strong experience with small molecules and ADCs/PDCs
- Proven track record supporting IND-enabling programs
- Working knowledge of ICH guidelines (M3, S6, S9) and GLP requirements
- Oncology drug development experience preferred
Preferred Experience
- PDC/ADC development and payload-related toxicity assessment
- Regulatory interactions (FDA/EMA/PMDA)
- Certification of DABT is preferred
- Cytokine-mediated toxicity experience
- Strong scientific communication and decision-making skills
- Join us to contribute your expertise in toxicology to groundbreaking projects that aim to improve patient outcomes worldwide. We value innovation, collaboration, and a passion for scientific discovery—if you’re ready to make a meaningful impact in drug development, we want to hear from you!
Pay: $250.00 - $300.00 per hour
Work Location: Remote
