Director of Nonclinical Safety (AI Drug Discovery)

Location: Cambridge, Massachusetts, United States; hybrid work with office attendance 3 days per week

Company

hirify.global applies frontier AI and machine learning to drug discovery, developing predictive and generative models for novel medicines and digital biology.

What you will do

• Lead, build, and scale the Nonclinical Safety function within an AI-first drug development environment.
• Define and execute phase-appropriate nonclinical safety and translational strategies for small-molecule oncology and non-oncology programs.
• Lead post-IND toxicology activities, including chronic, reproductive, and carcinogenicity studies, as required for development and registration.
• Integrate exploratory biomarkers, exposure-based modeling, in silico safety predictions, digital pathology, and predictive DILI models with traditional safety data.
• Manage external CROs and consultants to ensure data quality, timelines, and cost efficiency.
• Lead nonclinical regulatory strategy, documentation, and interactions with FDA, EMA, and other global health authorities.

Requirements

• PhD, DVM, or equivalent degree in cell and molecular biology, toxicology, pathology, pharmacology, or a related field.
• 12+ years of experience in nonclinical safety and toxicology within the biotech or pharmaceutical industry.
• Demonstrated success in small-molecule drug development across oncology and non-oncology indications.
• Experience advancing programs from discovery through post-IND clinical development and late-stage registration, including NDA/BLA submissions.
• Strong experience selecting, auditing, and managing external CRO vendors for GLP toxicology studies.
• Interest in or hands-on experience with computational toxicology, machine learning applications in safety assessment, or in silico predictive models.

Nice to have

• Board certification in toxicology.
• Experience developing biologics and other novel therapeutic platforms.

Culture & Benefits

• Hybrid working model with regular in-person collaboration.
• Interdisciplinary collaboration across drug discovery, machine learning, preclinical development, clinical pharmacology, regulatory affairs, quality, and manufacturing.
• Values centered on thoughtful science, bravery, determination, and collaboration.
• Environment focused on shared learning, inclusion, employee support, and scientific rigor.