About GondolaBio GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.
Who You Are
- You are an experienced toxicologist with deep expertise in oligonucleotide therapeutics.
- You bring strong scientific judgment and a track record of designing, executing, and interpreting nonclinical safety programs that support regulatory submissions and clinical development.
- You are hands-on, rigorous, and comfortable working through programs at high speed and navigating through complex or unexpected toxicology findings.
- You integrate toxicology, toxicokinetics, pharmacology, biodistribution, histopathology, and clinical context to assess human relevance and guide program decisions.
- You work effectively across Research, DMPK, Clinical, Regulatory, and CMC and thrive in a lean environment that relies heavily on CROs, consultants, and external partners.
- Above all, you maintain scientific integrity and keep patient safety at the center of every decision.
Key Responsibilities
- Provide scientific and operational leadership for nonclinical safety programs from candidate selection through clinical development, including: Toxicology Strategy and Study Design Develop integrated nonclinical safety strategies for oligonucleotide therapeutic programs.
- Design and oversee exploratory, IND-enabling, and clinical-supporting toxicology studies, including general toxicology, safety pharmacology, genotoxicity, reproductive toxicology, and other specialized studies as appropriate.
- Recommend relevant species, dose levels, dosing routes, dosing intervals, recovery periods, and safety-monitoring parameters based on pharmacology, exposure, tissue distribution, and anticipated clinical use.
- Establish appropriate safety margins and translate nonclinical findings into clinical dose-selection and risk-mitigation strategies.
- Oligonucleotide Safety Assessment Lead the evaluation of toxicities associated with oligos, conjugates, delivery technologies, and their metabolites.
- Assess potential class-related and platform-related findings, including effects involving the liver, kidney, platelets, coagulation, immune activation, complement, injection or infusion reactions, and other relevant organ systems.
- Integrate toxicology, toxicokinetics, biodistribution, pharmacology, bioanalytical, clinical pathology, and histopathology data to determine mechanism, dose dependence, reversibility, species relevance, and potential human risk.
- Lead investigations of unexpected findings and develop scientifically rigorous follow-up strategies.
- Study Execution and CRO Oversight Select, manage, and provide scientific oversight of CROs, consultants, pathologists, and other external partners.
- Review and approve study designs, protocols, amendments, data, pathology findings, and final reports.
- Ensure studies are conducted with appropriate scientific rigor, quality standards, timelines, and regulatory compliance.
- Monitor study progress closely, identify emerging risks, and drive timely resolution of scientific and operational issues.
- Regulatory and Clinical Support Author and review toxicology sections of regulatory submissions, including pre-IND briefing packages, INDs, investigator brochures, annual reports, and responses to regulatory questions.
- Represent toxicology in interactions with global regulatory authorities and external experts.
- Translate nonclinical findings into practical clinical monitoring, stopping rules, dose-escalation criteria, and risk-management plans.
- Provide toxicology support throughout clinical development, including assessment of emerging clinical safety findings and their relationship to the nonclinical data.
- Cross-Functional Leadership Partner closely with Research, DMPK, Clinical Development, Regulatory Affairs, CMC, Bioanalytics, and Quality to deliver integrated development plans.
- Communicate complex toxicology findings clearly to program teams, senior leadership, boards, investigators, and external advisors.
- Contribute to candidate selection, portfolio prioritization, due diligence, and program investment decisions.
- Build toxicology capabilities, processes, and external networks appropriate for a lean, rapidly growing organization.
