Director of Nonclinical Safety
AI-first drug design and development company building a unified drug-design engine to advance new medicines.
Funding history
Investors
About Isomorphic Labs
Isomorphic Labs uses predictive and generative AI models, computational biology, and drug-design expertise to develop therapeutics across partnered and internal programs.
Skills
Candidate Availability
Required and preferred rules are kept separate and reflect the wording in the original posting.
About the Role
You will build and scale the nonclinical safety function for early-development programs. You will define safety and translational strategies, oversee toxicology studies and CROs, integrate AI-derived safety predictions, support regulatory documentation and health-authority interactions, and help establish data feedback loops for predictive safety models.
Requirements
- PhD, DVM, or equivalent in Cell and Molecular Biology, Toxicology, Pathology, Pharmacology, or a related field
- 12+ years of nonclinical safety and toxicology experience in biotech or pharma
- Small-molecule drug-development experience in oncology and non-oncology
- Experience with computational toxicology, machine learning, or in silico predictive models
- Experience advancing programs through post-IND development and late-stage registration
- Experience selecting, auditing, and managing CROs for GLP toxicology studies
Responsibilities
- Build and scale the Nonclinical Safety function
- Define and execute nonclinical safety and translational strategies
- Lead post-IND nonclinical toxicology work
- Integrate biomarkers and exposure-based modeling into safety strategies
- Integrate in silico safety predictions with traditional safety data
- Collaborate with development, pharmacology, regulatory, quality, and manufacturing functions
- Manage CROs and consultants
- Lead nonclinical regulatory strategy and documentation
- Represent the company in FDA and EMA interactions
- Validate and defend AI-derived safety data and predictive models