Senior Director – Oligo Toxicology

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

💵 $275 000 - $350 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 1%

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GondolaBio

Site WebLinkedInTous les Emplois

11 - 50 employés

Fondée en 2024

🏥 Santé

💼 Conseil

🏭 Fabrication

💰 €300 000 000 Venture Round - GondolaBio en 2024-08

Healthcare • Consulting • Manufacturing

GondolaBio est une entreprise biopharmaceutique en phase clinique, lancée en 2024 et affiliée à BridgeBio Pharma, concentrée sur le développement de traitements révolutionnaires pour les patients atteints de maladies génétiques. La société utilise une approche allégée et décentralisée pour accélérer la recherche et le développement en phase initiale à travers de multiples modalités (y compris les petites molécules et les thérapies à base d'oligonucléotides) et construit un pipeline diversifié ciblant des affections génétiques rares et négligées telles que l'EPP/XLP avec son programme principal PORT-77. GondolaBio place les besoins des patients au centre de ses préoccupations et vise à apporter plus rapidement des traitements modificateurs de maladies à des populations dépourvues de thérapies approuvées.

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

🎯 Exigences

• 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)

🏖️ Avantages

• 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