Your impact 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.
What you will do 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 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.
External Partnerships & Regulatory- 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.
Skills and 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 is required. 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.
- 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.
Attributes: - Enterprise mindset; able to bridge the gap between computational AI teams and traditional drug development.
- A strong 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 the highest standards of scientific rigor and ethics.
- Strong communicator who can translate complex safety and biomarker and computational toxicology data into clear, audience-appropriate risk assessments, building trust across early development.
Culture and valuesWe are guided by our shared values. It's not about finding people who think and act in the same way. These values help to guide our work and will continue to strengthen it.
ThoughtfulThoughtful at Iso is about curiosity, creativity and care. It is about good people doing good, rigorous and future-making science every single day.
BraveBrave at Iso is about fearlessness, but it's also about initiative and integrity. The scale of the challenge demands nothing less.
DeterminedDetermined at Iso is the way we pursue our goal. It's a confidence in our hypothesis, as well as the urgency and agility needed to deliver on it. Because disease won't wait, so neither should we.
TogetherTogether at Iso is about connection, collaboration across fields and catalytic relationships. It's knowing that transformation is a group project, and remembering that what we're doing will have a real impact on real people everywhere.
Creating an extraordinary companyWe believe that to be successful we need a team with a range of skills and talents. We're building an environment where collaboration is fundamental, learning is shared and every employee feels supported and able to thrive. We value unique experiences, knowledge, backgrounds, and perspectives, and harness these qualities to create extraordinary impact.
Hybrid workingIt's hugely important for us to share knowledge and build strong relationships with each other, and we find it easier to do this if we spend time together in person. This is why we follow a hybrid model, and
would require you to be able to come into the office 3 days a week (currently Tuesday, Wednesday, and one other day depending on which team you're in). If you have additional needs that would prevent you from following this hybrid approach, we'd be happy to talk through these if you're selected for an initial screening call.
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