Senior Director, Oligonucleotide Toxicology

GondolaBio, LLC; San Francisco (CA); On-site; USD 275,000 - 350,000; Full time

Benefits offered by this job

Equity

Health benefits

Performance bonus

Retirement plan

Job summary

GondolaBio seeks an experienced toxicologist to lead nonclinical safety programs for oligonucleotide therapeutics. You will design studies, oversee CROs, and translate findings for regulatory submissions.

You will partner with Research, DMPK, Clinical Development, Regulatory Affairs, and CMC to ensure safe, efficient progression from candidate selection to clinical development, while maintaining scientific integrity and patient safety.

Qualifications

• 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 is 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 their relevance to humans.
• Experience managing CROs, consultants, and external pathology and toxicology partners.
• Strong record of 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, including:
• Toxicology Strategy and Study Design
• Study Execution and CRO Oversight
• Regulatory and Clinical Support
• Cross-Functional Leadership
• Translate nonclinical findings into practical clinical monitoring and risk-management plans.
• Lead investigations of unexpected findings and develop follow-up strategies.

Skills

Toxicology

Nonclinical safety

Oligonucleotide therapeutics

Regulatory submissions

CRO management

Histopathology

Toxicokinetics

Cross-functional collaboration

Team leadership

Education

PhD/ DVM/ MD or equivalent

Job description

GondolaBio seeks an experienced toxicologist to lead nonclinical safety programs for oligonucleotide therapeutics. You will design studies, oversee CROs, and translate findings for regulatory submissions.

You will partner with Research, DMPK, Clinical Development, Regulatory Affairs, and CMC to ensure safe, efficient progression from candidate selection to clinical development, while maintaining scientific integrity and patient safety.