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Director of Nonclinical Safety, Cambridge, MA

Isomorphic Labs· Clinical
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Hybrid (Cambridge, MA)full-timePosted 2mo ago

About the role

Director-level role to build and lead the nonclinical safety function in an AI-first drug development environment, supporting Early Development programs in oncology and non-oncology, with emphasis on integrating AI and translational strategies to de-risk compounds.

Responsibilities

  • Lead, build, and scale the Nonclinical Safety function within an AI-first drug development environment.
  • Serve as the primary internal expert for post-IND nonclinical safety ensuring quality, consistency, and scalability as compounds transition into clinical trials.
  • Establish a critical data feedback loop: ensure high-quality data are fed back to computational teams to continuously train, validate, and refine predictive nonclinical safety AI models.
  • Define and drive nonclinical safety and other translational strategies primarily for small molecule drug candidates in the Early Development phase across oncology and non-oncology indications.
  • Execute post-IND (NDA/MAA-enabling) nonclinical toxicology work, including chronic, reproductive, and carcinogenicity studies as needed.
  • Establish translational strategies by integrating exploratory nonclinical safety biomarkers and exposure-based modeling plans to predict and de-risk potential effects in humans.
  • Integrate in silico safety predictions (off-target liabilities, digital pathology, predictive DILI models) with traditional data to build robust, AI-augmented nonclinical safety profiles.
  • Collaborate with Preclinical Development, Clinical Pharmacology, Regulatory Affairs, Quality, and Pharmaceutical Sciences & Manufacturing to ensure seamless development of drug candidates.
  • Leverage network of global CROs and consultants for data quality, timelines, and cost efficiency.
  • Lead nonclinical regulatory strategy and contribute to INDs, IBs, DSURs, briefing books, and NDA/MAA modules (including USPI/labels).
  • Represent Isomorphic Labs in regulatory interactions and global health authority meetings (FDA, EMA) leveraging AI/LLM tools for documentation and data QC.
  • Validate, present, and defend AI-derived safety data and predictive models in interactions with FDA/EMA to advance acceptance of computational toxicology.

Qualifications

  • PhD, DVM, or equivalent in Cell & Molecular Biology, Toxicology, Pathology, Pharmacology, or related field. Board certification in toxicology desired.

Skills

Required:Nonclinical safety and toxicologySmall molecule and biologics drug developmentComputational toxicology / AI in safety assessmentExternal CRO/vendor management
Last updated Aug 19, 2026. Interested? Apply on the company site.

About Isomorphic Labs

Reimagining Drug Discovery Process with AI

Isomorphic Labs is building a future where frontier AI can help to unlock deeper scientific insights, faster breakthroughs, and life-changing medicines.

AIBiotechnologyDrug DiscoveryPharmaceuticalsliquid-ai-recruiting-target
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