Senior Director, Oligonucleotide Toxicology (Remote)

GondolaBio, LLC; Northern (KY); Hybrid; USD 275,000 - 350,000; Full time

Benefits offered by this job

Remote with travel to Bay Area

Bonus & equity

Job summary

GondolaBio seeks an experienced toxicologist to lead nonclinical safety programs for oligonucleotide therapeutics. You will design studies, oversee CROs, and advise on regulatory submissions from IND to clinical development.

You will integrate toxicology, toxicokinetics, biodistribution, immunotoxicology, and histopathology data to guide human risk and dose selection while collaborating across Research, DMPK, Clinical, and Regulatory teams in a lean, fast-moving environment.

Qualifications

• PhD, DVM, MD, or equivalent advanced degree in toxicology, pharmacology, pathology, or related field.
• Minimum of 10 years of relevant biopharmaceutical toxicology experience, including leading nonclinical safety programs.
• Direct experience developing oligonucleotide therapeutics.
• 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 managing CROs, consultants, and external partners.
• Cross‑functional collaboration with Research, DMPK, Clinical Development, Regulatory Affairs, and CMC.
• Excellent scientific writing, communication, and presentation skills.
• Thrives in a hands‑on, detail‑oriented role and is energized by directly driving work forward in a fast‑moving environment.

Responsibilities

• Provide scientific and operational leadership for nonclinical safety programs from candidate selection through clinical development.
• Lead nonclinical safety strategies for oligonucleotide programs and oversee toxicology studies.
• Select, manage, and provide scientific oversight of CROs, consultants, pathologists, and external partners.
• Review study designs, protocols, amendments, data, pathology findings, and final reports.
• Author toxicology sections of regulatory submissions and engage with global regulatory authorities.
• Translate nonclinical findings into clinical monitoring, stopping rules, dose‑escalation criteria, and risk‑management plans.

Skills

Toxicology leadership

Nonclinical safety

Oligonucleotide toxicology

Cross‑functional collaboration

Regulatory submissions

Education

PhD, DVM, MD, or equivalent advanced degree in toxicology, pharmacology, pathology, or related

Tools

CRO management

Job description

GondolaBio seeks an experienced toxicologist to lead nonclinical safety programs for oligonucleotide therapeutics. You will design studies, oversee CROs, and advise on regulatory submissions from IND to clinical development.

You will integrate toxicology, toxicokinetics, biodistribution, immunotoxicology, and histopathology data to guide human risk and dose selection while collaborating across Research, DMPK, Clinical, and Regulatory teams in a lean, fast-moving environment.