Senior Director​/Vice President, Oligo Toxicology

Fully Remote
• Remote with travel to Bay Area

Description

Gondola Bio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. Gondola Bio is an independent sister company to Bridge Bio, originally carved out in 2024 after securing $300M in private financing from external investors. Gondola Bio aims to leverage cutting‑edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

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.

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…