Senior Director – Oligo Toxicology

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $275k - $350k / year

⏰ Full Time

🟠 Senior

👔 Director

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GondolaBio

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $300M Venture Round - GondolaBio on 2024-08

Healthcare • Consulting • Manufacturing

GondolaBio is a clinical-stage biopharmaceutical company launched in 2024 and affiliated with BridgeBio Pharma, focused on developing breakthrough therapeutics for patients with genetic diseases. The company uses a lean, decentralized approach to accelerate early-stage research and development across multiple modalities (including small molecules and oligonucleotide therapies) and is building a diverse pipeline targeting rare and underserved genetic conditions such as EPP/XLP with its lead program PORT-77. GondolaBio centers patient needs and aims to bring disease-modifying treatments more quickly to populations lacking approved therapies.

📋 Description

• Provide scientific and operational leadership for nonclinical safety programs from candidate selection through clinical development • Develop integrated nonclinical safety strategies for oligonucleotide therapeutic programs • Design and oversee exploratory, IND-enabling, and clinical-supporting toxicology studies • Recommend species, dose levels, dosing routes, dosing intervals, recovery periods, and safety-monitoring parameters • Establish safety margins and translate nonclinical findings into clinical dose-selection and risk-mitigation strategies • Lead evaluation of toxicities associated with oligos, conjugates, delivery technologies, and metabolites • Integrate toxicology, toxicokinetics, biodistribution, pharmacology, bioanalytical, clinical pathology, and histopathology data • Lead investigations of unexpected findings and develop follow-up strategies • Select, manage, and provide scientific oversight of CROs, consultants, pathologists, and external partners • Review and approve study designs, protocols, amendments, data, pathology findings, and final reports • Ensure scientific rigor, quality standards, timelines, and regulatory compliance • Monitor study progress, identify emerging risks, and resolve scientific and operational issues • Author and review toxicology sections of regulatory submissions, including pre-IND packages, INDs, investigator brochures, annual reports, and regulatory responses • Represent toxicology in interactions with global regulatory authorities and external experts • Translate nonclinical findings into clinical monitoring, stopping rules, dose-escalation criteria, and risk-management plans • Support toxicology throughout clinical development and assess emerging clinical safety findings • Partner with Research, DMPK, Clinical Development, Regulatory Affairs, CMC, Bioanalytics, and Quality • Communicate complex toxicology findings to program teams, senior leadership, boards, investigators, and external advisors • Contribute to candidate selection, portfolio prioritization, due diligence, and investment decisions • Build toxicology capabilities, processes, and external networks

🎯 Requirements

• PhD, DVM, MD, or equivalent advanced degree in toxicology, pharmacology, pathology, or a related scientific discipline • Minimum of 10 years of relevant biopharmaceutical toxicology experience, including experience leading nonclinical safety programs • Direct experience developing oligonucleotide therapeutics required • Experience designing and interpreting exploratory and GLP toxicology studies supporting INDs or equivalent global regulatory submissions • Strong understanding of oligonucleotide-related toxicities, toxicokinetics, tissue distribution, immunotoxicology, clinical pathology, and histopathology • Experience advancing programs from candidate selection into clinical development • Experience investigating complex or unexpected toxicology findings and assessing relevance to humans • Experience managing CROs, consultants, and external pathology and toxicology partners • Strong cross-functional collaboration with Research, DMPK, Clinical Development, Regulatory Affairs, and CMC • Excellent scientific writing, communication, and presentation skills • Hands-on, detail-oriented approach in a fast-moving environment • Board certification in toxicology, such as DABT, or veterinary pathology, such as DACVP (nice-to-have) • Experience with lipid-, peptide-, antibody-, or GalNAc-conjugated oligonucleotides (nice-to-have) • Experience with intravenous and subcutaneous oligonucleotide development programs (nice-to-have) • Experience supporting rare or genetic disease programs (nice-to-have) • Experience interacting directly with the FDA and other global regulatory authorities (nice-to-have)

🏖️ Benefits

• Patient Days • Culture inspired by company values • Decentralized model with decision-making close to the science • Ownership of program vision and career path • Collaborative, fast-paced, data-driven environment • Learning and development resources • Competitive compensation and benefits package including performance bonus, equity, health, welfare, and retirement programs • Flexible PTO • Rapid career advancement for strong performers • Potential to work on multiple programs across therapeutic areas • Partnerships with leading institutions • Commitment to Diversity, Equity & Inclusion