Senior Director – Oligo Toxicology

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide scientific and operational guidance for nonclinical safety programs from candidate selection to clinical development.

• Develop comprehensive nonclinical safety strategies for oligonucleotide therapeutic programs.

• Design and supervise exploratory, IND-enabling, and clinical-supporting toxicology studies.

• Recommend appropriate species, dose levels, dosing routes, intervals, recovery periods, and safety-monitoring parameters.

• Establish safety margins and translate nonclinical findings into clinical dose-selection and risk-mitigation strategies.

• Lead the evaluation of toxicities related to oligonucleotides, conjugates, delivery technologies, and metabolites.

• Integrate data from toxicology, toxicokinetics, biodistribution, pharmacology, bioanalytical, clinical pathology, and histopathology.

• Oversee investigations of unexpected findings and develop follow-up strategies.

• Select, manage, and provide scientific oversight for CROs, consultants, pathologists, and external partners.

• Review and approve study designs, protocols, amendments, data, pathology findings, and final reports.

• Ensure adherence to scientific rigor, quality standards, timelines, and regulatory compliance.

• Monitor study progress, identify emerging risks, and resolve scientific and operational challenges.

• Author and review toxicology sections of regulatory submissions, including pre-IND packages, INDs, investigator brochures, annual reports, and regulatory responses.

• Represent toxicology in discussions 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 evaluate emerging clinical safety findings.

• Collaborate with Research, DMPK, Clinical Development, Regulatory Affairs, CMC, Bioanalytics, and Quality teams.

• 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 an equivalent advanced degree in toxicology, pharmacology, pathology, or a related scientific discipline.

• At least 10 years of relevant biopharmaceutical toxicology experience, including leading nonclinical safety programs.

• Direct experience in developing oligonucleotide therapeutics is essential.

• Experience in 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.

• Proven experience advancing programs from candidate selection into clinical development.

• Experience in investigating complex or unexpected toxicology findings and assessing their relevance to humans.

• Experience managing CROs, consultants, and external pathology and toxicology partners.

• Strong cross-functional collaboration skills with Research, DMPK, Clinical Development, Regulatory Affairs, and CMC.

• Excellent scientific writing, communication, and presentation abilities.

• A hands-on, detail-oriented approach in a dynamic environment.

• Board certification in toxicology, such as DABT, or veterinary pathology, such as DACVP (preferred but not required).

• Experience with lipid-, peptide-, antibody-, or GalNAc-conjugated oligonucleotides (preferred but not required).

• Experience with intravenous and subcutaneous oligonucleotide development programs (preferred but not required).

• Experience supporting rare or genetic disease programs (preferred but not required).

• Experience interacting directly with the FDA and other global regulatory authorities (preferred but not required).

🏝️ Benefits

• Patient Days.

• A culture inspired by company values.

• A decentralized model with decision-making close to the science.

• Ownership of program vision and career trajectory.

• A collaborative, fast-paced, data-driven environment.

• Access to learning and development resources.

• A competitive compensation and benefits package, including performance bonuses, equity, health, welfare, and retirement programs.

• Flexible PTO.

• Rapid career advancement opportunities for high performers.

• The potential to work on multiple programs across various therapeutic areas.

• Partnerships with leading institutions.

• A commitment to Diversity, Equity & Inclusion.