Associate Director, Toxicology; Nonclinical Safety Evaluation
Listed on 2026-07-07
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Research/Development
Regulatory Compliance Specialist, Research Scientist, Clinical Research
City Therapeutics is a biopharmaceutical company harnessing next-generation engineering to improve and expand the reach of RNAi-based medicines. The company is building a pipeline of innovative RNAi therapeutics to make a significant impact for patients across multiple therapeutic areas. Co-founded by pioneering executives and scientists in RNAi, City Therapeutics is based in Cambridge, MA, and has raised $140 million from leading life sciences investors.
RoleWe’re seeking an Associate Director, Nonclinical Safety Evaluation (NSE) who will play a pivotal role in overseeing and critically evaluating nonclinical safety studies across City’s RNAi therapeutic programs. This is a highly visible, hands‑on role for someone who brings strong scientific judgment, deep toxicology expertise, and a sharp eye for study design, data quality, and interpretation.
How You’ll Contribute- Oversee non-GLP and GLP nonclinical safety studies across discovery and development‑stage programs, with a focus on quality, execution, interpretation, and fit‑for‑purpose study design.
- Serve as the primary scientific reviewer for outsourced nonclinical safety studies, critically evaluating protocols, amendments, reports, and raw or interpreted data to ensure rigor, clarity, and appropriate conclusions.
- Provide expert interpretation of toxicology studies, including general toxicology, safety pharmacology, genetic toxicology, and, where applicable, reproductive toxicology and carcinogenicity findings, highlighting key results, risks, trends, and development implications.
- Identify data gaps, inconsistencies, or study conduct issues, and work with internal and external teams to resolve them efficiently and scientifically.
- Participate actively in cross‑functional team meetings to communicate study progress, interpret findings, and provide nonclinical safety input to broader program discussions.
- Partner closely with Chemistry, Biology, Translational Sciences, CMC, Regulatory Affairs, Clinical Development, and other relevant functions and program teams to contextualize nonclinical safety findings and support next‑step recommendations.
- Contribute to the planning and monitoring of nonclinical safety studies required to support candidate progression and regulatory submissions.
- Support authoring and review of nonclinical summaries, study interpretation sections, and regulatory documents, including materials supporting IND‑enabling packages.
- Represent Nonclinical Safety Evaluation in cross‑functional discussions, clearly communicating study outcomes, risks, and recommendations.
- Help maintain high standards for external study oversight, documentation, data review, and reporting practices across the function.
- Stay current on evolving toxicology methods, nonclinical safety expectations, and regulatory guidance relevant to RNAi and oligonucleotide therapeutics.
- PhD or DVM, or equivalent advanced degree in Toxicology, Pharmacology, Pathology, Veterinary Sciences, or a related field, with 5+ years, Masters with 7+ or a Bachelors with 10+ of relevant experience in biotech or pharmaceutical drug development, or direct experience as a Study Director at a GLP‑qualified CRO.
- Strong experience overseeing outsourced nonclinical safety studies and critically reviewing protocols, data, and final reports.
- Deep expertise in the interpretation of toxicology data, including general toxicology, genetic toxicology, reproductive toxicology, carcinogenicity, and related nonclinical safety assessments, with sound scientific judgment and attention to detail.
- Strong understanding of GLP and non‑GLP study conduct, study design, and reporting standards.
- Experience contributing to regulatory packages and supporting nonclinical components of development milestones.
- Ability to assess study quality, identify issues early, and communicate risks and recommendations clearly to cross‑functional stakeholders.
- Experience working with CROs and external collaborators to ensure timely, high‑quality study execution and reporting.
- Previous siRNA therapeutic development experience is a plus.
- Prior small molecule development experience is strongly preferred.
- DABT certification is a…
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