Position Overview
We are seeking a strategic and hands‑on Principal Scientist in Toxicology & Pharmacology to contribute to strategy and execution of nonclinical safety and pharmacology for our next‑generation targeted therapy technology based on pre‑targeting enabled by click chemistry.
You will work together with chemistry, biology, and ADME/PK teams to design, lead, and interpret toxicology and pharmacology studies that contribute to therapeutic design, candidate selection, IND‑enablement, and clinical strategy in a fast‑paced startup environment.
Key Responsibilities Nonclinical Safety Strategy
- Contribute to and execute toxicology strategy for pre‑targeted therapeutics, including IND‑enabling studies
- Design GLP and non‑GLP toxicology studies
- Identify, characterize, and mitigate safety risks
- Establish safety margins and therapeutic index for candidate molecules
Pharmacology & Translational Science
- Contribute to pharmacology strategy to demonstrate proof of mechanism and proof of concept
- Design and interpret in vivo efficacy studies including model selection/characterization, study design, working with CROs to execute the study, and data analysis/presentation
- Define exposure‑response relationships
- Collaborate on dose and schedule optimization
Cross‑Functional Integration
- Partner with ADME/PK to integrate pharmacokinetics, biodistribution, and exposure‑response modeling
- Work closely with chemistry and protein engineering teams to guide design toward safer and more effective molecules
- Collaborate with CMC and analytical teams to ensure appropriate characterization of each therapeutic component
- Support regulatory strategy, including authoring and reviewing IND sections (e.g., nonclinical overview, tox summaries)
Risk Assessment & Decision Making
- Develop safety assessment frameworks tailored to our pre‑targeting approach
- Drive candidate selection by balancing efficacy, exposure, and safety
- Present findings and recommendations to leadership, board members, and external partners
Required Qualifications
- PhD, DVM, or equivalent in Toxicology, Pharmacology, or related discipline
- 4+ years of industry experience in nonclinical safety and/or pharmacology
- Demonstrated experience leading IND‑enabling toxicology programs
- Strong background in small molecules, biologics, or targeted delivery systems (e.g., ADCs, radio conjugates, bispecifics)
- Experience designing and interpreting in vivo toxicology and pharmacology studies
- Familiarity with regulatory expectations (FDA/ICH) for nonclinical development
Preferred Qualifications
- Experience with pre‑targeting strategies
- Familiarity with bioorthogonal click chemistry (e.g., tetrazine–TCO systems)
- Background in oncology or other areas involving targeted therapies
- Experience evaluating on‑target vs. off‑target toxicities in complex systems
- Knowledge of safety considerations for reactive intermediates or payload‑driven toxicity
- Experience integrating PK/PD and tox data for translational modeling
- Strong publication record and presentation skills
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