Associate Director, Toxicology (Nonclinical Safety Evaluation)

The role

The Associate Director, Nonclinical Safety Evaluation will oversee and evaluate nonclinical safety studies for RNAi therapeutic programs. This role involves providing scientific oversight of outsourced studies and interpreting toxicology data to support regulatory advancement.

What you will do

• Oversee non-GLP and GLP nonclinical safety studies across discovery and development-stage programs
• Serve as the primary scientific reviewer for outsourced nonclinical safety studies
• Provide expert interpretation of toxicology studies including general, safety pharmacology, genetic, reproductive, and carcinogenicity findings
• Identify data gaps, inconsistencies, or study conduct issues
• Participate in cross-functional team meetings to communicate study progress and findings
• Partner with Chemistry, Biology, Translational Sciences, CMC, Regulatory Affairs, and Clinical Development
• Contribute to the planning and monitoring of nonclinical safety studies for candidate progression and regulatory submissions
• Support authoring and review of nonclinical summaries and regulatory documents for IND-enabling packages
• Represent Nonclinical Safety Evaluation in cross-functional discussions
• Maintain high standards for external study oversight, documentation, and reporting

Required qualifications

• PhD or DVM, or equivalent advanced degree in Toxicology, Pharmacology, Pathology, Veterinary Sciences, or a related field, with 5+ years of relevant experience in biotech or pharmaceutical drug develo
• Masters with 7+ years of relevant experience in biotech or pharmaceutical drug development
• Bachelors with 10+ years of relevant experience in biotech or pharmaceutical drug development
• Direct experience as a Study Director at a GLP-qualified CRO
• Strong experience overseeing outsourced nonclinical safety studies and reviewing protocols, data, and reports
• Deep expertise in the interpretation of toxicology data
• Strong understanding of GLP and non-GLP study conduct, design, and reporting standards
• Experience contributing to regulatory packages and supporting nonclinical components of development milestones
• Ability to assess study quality and communicate risks to stakeholders
• Experience working with CROs and external collaborators

Nice to have

• Previous siRNA therapeutic development experience
• Prior small molecule development experience
• DABT certification

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package

Before you apply

• City Therapeutics is accepting applications from direct candidates only

About the company

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 and is based in Cambridge, MA.