Director, Toxicology

Apply Company Background

Gondola Bio is a clinical-stage biopharmaceutical company focused on developing next-generation therapeutics for genetic diseases. Originally launched as Bridge

BioX, a subsidiary of Bridge Bio, Gondola Bio secured $300M in private financing from external investors in 2024 and became an independent company within the Bridge Bio ecosystem. The company aims to leverage cutting-edge biological research to create breakthrough medicines addressing high unmet needs across multiple therapeutic areas, including neurology, pulmonology, cardiology, nephrology, and endocrinology. Located on the Stanford Life Sciences campus, Gondola Bio fosters a unique hybrid environment where top scientists from around the world collaborate with senior leadership and advisors, blending industry expertise with academic innovation.

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Own the nonclinical toxicology strategy for multiple discovery programs as they advance from late lead optimization through development‑candidate (DC) nomination, IND filing, and into early clinical studies. You’ll architect and execute phase‑appropriate safety strategies across small‑molecule. The role is hands‑on, cross‑functional, and highly decision‑oriented in Gondola Bio’s lean, time‑critical environment.

• Strat
• Pre‑DCN
• GLP
• Regulatory
• QA
• Own the tox strategy for multiple programs on cross‑functional teams from Lead Op ? DC nomination ? IND, then continue guiding safety support through early clinical development, balancing speed, cost, and risk.
• Design, oversee, and interpret non‑GLP and GLP toxicity and safety pharmacology studies in line with international and country‑specific guidelines.
• Effectively communicate findings and impact with internal stakeholders, health authorities, and clinical investigators through presentation and authoring of nonclinical sections of regulatory and clinical documents.
• Act as a reviewer and toxicology subject matter expert conducting diligence on external opportunities with the Asset Acquisition team.
• Select, contract, and manage CROs—proven external‑oversight experience is required—adapting study design to evolving guidelines, timelines, and resource constraints while ensuring GLP compliance, scientific rigor, and fiscal discipline.
• Drive inspection/readiness activities and represent Gondola Bio in regulatory interactions.

• Ph.D., D.V.M., or equivalent in toxicology, pharmacology, or related field; DABT preferred.
• 10+?years of industry experience owning nonclinical safety packages through multiple internal stage gates and at least one successful IND and early‑phase clinical support.
• Experience with oral delivery of small molecules; additional routes and modality experience preferred.
• Track record designing and interpreting repeat‑dose tox, genotox, safety pharm, TK, and mechanistic studies.
• Demonstrated regulatory‑facing experience (pre‑IND/IND/Type B/C meetings, written responses).
• Fluent in GLP principles, vendor oversight, and crafting global‑ready packages.
• High‑clarity communicator who excels in lean, fast‑moving settings with a focus on decisional data.

• Portfolio‑level platform experience leveraging common tox tools across assets.
• Translational / biomarker strategy to bridge preclinical findings into clinics.
• Mechanistic follow‑up expertise (target linkage, in‑vitro tox, tissue cross‑reactivity).
• [EH1]

• Patient Champions, who put patients first and uphold strict ethical standards.
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset.
• Truth Seekers, who are detailed, rational, and humble problem solvers.
• Individuals Who Inspire Excellence in themselves and those around them.
• High‑quality executors, who execute against goals and milestones with quality, precision, and speed.

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts.
• A culture inspired by our values: put patients first, think independently, be…