Director of Nonclinical Safety, Cambridge, MA

Isomorphic Labs
Cambridge
Workplace: HybridFull timeFunction: Executive & General ManagementExperience: 12+ yearsEducation: phdSkills: ["Enterprise mindset","Analytical","Communicating risk assessments","Bridging computational and traditional teams","Scientific rigor"]

Lead and scale the Nonclinical Safety function in an AI-first drug development environment, partnering with Early Development and broader translational teams. Define and execute phase-appropriate nonclinical safety strategies for small molecule programs across oncology and non-oncology, integrating computational safety approaches and biomarker/exposure modeling. Own post-IND toxicology work, establish feedback loops to improve predictive AI models, and drive regulatory safety strategy and documentation interactions with FDA/EMA.

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Isomorphic Labs
Isomorphic Labs
2 days ago

Director of Nonclinical Safety, Cambridge, MA

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Last checked: 2 hours agoStatus: Live

Job Summary

Lead and scale the Nonclinical Safety function in an AI-first drug development environment, partnering with Early Development and broader translational teams. Define and execute phase-appropriate nonclinical safety strategies for small molecule programs across oncology and non-oncology, integrating computational safety approaches and biomarker/exposure modeling. Own post-IND toxicology work, establish feedback loops to improve predictive AI models, and drive regulatory safety strategy and documentation interactions with FDA/EMA.
Location: Cambridge
Workplace: Hybrid
Employment Type: Full time
Job Function: Executive & General Management
Seniority: Director level

Key Responsibilities

  • •Lead, build, and scale the Nonclinical Safety function within an AI-first drug development environment.
  • •Serve as primary internal expert for post-IND nonclinical safety to ensure quality, consistency, and scalability as compounds enter clinical trials.
  • •Define and drive nonclinical safety and translational strategies across oncology and non-oncology indications, primarily for small molecule candidates.
  • •Execute post-IND nonclinical toxicology work (including chronic, reproductive, and carcinogenicity studies as needed) and integrate translational biomarker/exposure modeling plans.
  • •Leverage global CRO/vendor networks for GLP studies and lead nonclinical regulatory strategy and documentation (e.g., INDs, DSURs, NDA/MAA modules), representing the company in FDA/EMA interactions as needed.

Key Requirements

  • •PhD, DVM, or equivalent in Cell & Molecular Biology, Toxicology, Pathology, Pharmacology, or a related field; board certification in toxicology is desired.
  • •12+ years of experience in nonclinical safety and toxicology in the biotech/pharma industry.
  • •Proven experience in small molecule drug development for oncology and non-oncology indications (biologics experience is a plus).
  • •Hands-on interest or experience in computational toxicology, machine learning applications in safety assessment, and evaluating in silico predictive models.
  • •Track record advancing programs from discovery through post-IND clinical development and late-stage registration (NDA/BLA), including selecting, auditing, and managing external CRO vendors for GLP toxicology studies.
Experience:12+ yearsBiotechPharmaDrug discoveryComputational toxicologyNonclinical safety
Education:PhD / Doctorate in Cell & Molecular Biology, Toxicology, Pathology, Pharmacology (or related field)
Skills:Enterprise mindsetAnalyticalCommunicating risk assessmentsBridging computational and traditional teamsScientific rigor
Certifications:Board certification in toxicology
Languages:English
Tech Stack:Artificial intelligenceAI-first environmentMachine learningComputational toxicologyIn silico safety predictionsDigital pathologyPredictive DILI modelsLLM toolsBiomarker modelingExposure-based modeling

Company Brief

Isomorphic Labs
Uses machine learning and computational biology to accelerate drug discovery and design novel therapeutics by modeling protein structures, mechanisms, and interactions to identify promising targets and candidates.
Industry: Biotech
Company Size: Medium (51 to 250 employees)
Growth: Growth Stage Startup
Headquarters: London, United Kingdom
Founded: 2021
WebsiteLinkedIn