Director of Nonclinical Safety, Cambridge, MA

Isomorphic Labs•Cambridge, MA

4d•Hybrid

About The Position

Isomorphic Labs is seeking a highly motivated and experienced Director of Nonclinical Safety to build its nonclinical safety function, supporting programs in the Early Development phase. This role reports directly to the Head of Early Development and serves as a key member of the Early Development team. The primary responsibilities include defining and executing phase-appropriate nonclinical safety strategies and pioneering the integration of artificial intelligence for oncology and non-oncology programs.

Requirements

PhD, DVM, or equivalent in Cell & Molecular Biology, Toxicology, Pathology, Pharmacology, or a related field.
12+ years of experience in nonclinical safety and toxicology in the biotech/pharma industry.
Demonstrated success in small molecule drug development for oncology and non-oncology indications is required.
Experience in developing biologics and other novel platforms is highly desired.
Proven track record advancing programs from discovery through post-IND clinical development and late-stage registration (NDA/BLA).
Strong experience selecting, auditing, and managing external CRO vendors for GLP toxicology studies.

Nice To Haves

Board certification in toxicology is desired.
Additional experience in biologics is a plus.
A strong interest in, or hands-on experience with, computational toxicology, machine learning applications in safety assessment, or evaluating in silico predictive models.

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 our 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 seamlessly on 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 (e.g., off-target liabilities, digital pathology, predictive DILI models) with traditional data to help build robust, AI-augmented nonclinical safety profiles for compounds in development.
Collaborate closely with colleagues in Preclinical Development, Clinical Pharmacology, Regulatory Affairs, Quality, and Pharmaceutical Sciences & Manufacturing to ensure the seamless development of drug candidates.
Leverage network of global CRO’s and consultants, ensuring data quality, timelines, and cost efficiency in a fast-paced environment.
Lead nonclinical regulatory strategy and contribute to corresponding documentation, including 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) as appropriate, leveraging cutting-edge AI and LLM tools to accelerate document drafting, data QC, and narrative generation.
Participate in validating, presenting, and defending AI-derived safety data and predictive models in interactions with global health authorities (FDA, EMA) to advance the regulatory acceptance of computational toxicology.