Director of Nonclinical Safety, Cambridge, MA

About the role

We are seeking a highly motivated and experienced Director of Nonclinical Safety to build our nonclinical safety function supporting programs in the Early Development phase. Reporting directly to the Head of Early Development, you will serve as a key member of the Early Development team. In this critical role, you will be primarily responsible for defining and executing phase-appropriate nonclinical safety strategies as well as pioneering the integration of artificial intelligence in support of oncology and non-oncology programs.

About Isomorphic Labs

Isomorphic Labs (IsoLabs) was launched in 2021 to advance human health by building on and beyond the Nobel-winning AlphaFold system. Our interdisciplinary team of drug discovery experts and machine learning specialists has built powerful new predictive and generative AI models that accelerate scientific discovery at digital speed. Our name reflects the belief that there is an underlying symmetry between biology and information science. By harnessing AI’s capabilities, we model complex biological phenomena to design novel molecules, anticipate drug performance, and develop innovative medicines to treat and cure devastating diseases.

We have built a world-leading drug design engine comprising AI models capable of working across multiple therapeutic areas and drug modalities. Our strategic collaborations include partnerships with Eli Lilly, Novartis, and Johnson & Johnson, with the Novartis collaboration expanding in February 2025 to double its original scope. Our internal pipeline includes multiple programs in oncology and immunology. In March 2025, IsoLabs raised $600 million in its first external funding round, followed by a $2.1 billion Series B in May 2026, led by Thrive Capital with participation from Alphabet, GV, MGX, Temasek, CapitalG, and the UK Sovereign AI Fund.

Isomorphic Labs is scaling globally, with headquarters in London and offices in Lausanne, Switzerland, and Cambridge, Massachusetts. We continue to progress our internal candidate programs toward the clinic while advancing across modalities including small molecules, molecular glues, peptides, and antibodies.

Responsibilities

• Functional Leadership & Capability Building
  • 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.
• Portfolio & Program Strategy
  • Define and drive nonclinical safety and 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 build robust, AI-augmented nonclinical safety profiles.
  • Collaborate closely with colleagues in Preclinical Development, Clinical Pharmacology, Regulatory Affairs, Quality, and Pharmaceutical Sciences & Manufacturing to ensure seamless development of drug candidates.
• External Partnerships & Regulatory
  • Leverage a network of global CROs 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), leveraging 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 regulatory acceptance of computational toxicology.

Qualifications

• Essential:
  • 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.
  • Demonstrated success in small molecule drug development for oncology and non-oncology indications; experience with 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.
  • 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.
• Attributes:
  • Enterprise mindset; able to bridge the gap between computational AI teams and traditional drug development.
  • Enthusiasm for operating in an AI-first environment and leveraging cutting-edge automation in daily workflows.
  • Analytical and goal-oriented, with the ability to operate with urgency while maintaining scientific rigor and ethics.
  • Strong communicator who can translate complex safety, biomarker, and computational toxicology data into clear, audience-appropriate risk assessments.

Culture and values

• Thoughtful: Curiosity, creativity, and care drive our rigorous and future-making science.
• Brave: Fearlessness, initiative, and integrity define our approach to tackling challenges.
• Determined: Confidence in our hypothesis, urgency, and agility guide our pursuit of goals.
• Together: Collaboration across fields and catalytic relationships fuel our transformative impact.

We value unique experiences, knowledge, backgrounds, and perspectives, fostering an environment where collaboration is fundamental and every employee feels supported. We are committed to equal employment opportunities regardless of sex, race, religion, ethnic or national origin, disability, age, citizenship, marital status, sexual orientation, gender identity, pregnancy, or any other basis protected by law.

Schedule

We follow a hybrid model and require you to be in the office 3 days a week (currently Tuesday, Wednesday, and one other day depending on your team). If you have additional needs that would prevent you from following this hybrid approach, we encourage you to discuss accommodations during the screening process.