Director/Sr. Director, Nonclinical Toxicology

We are seeking an experienced and highly motivated Toxicologist to join our team. The successful candidate will play a critical role in the nonclinical safety evaluation of our drug candidates, working closely with cross-functional teams to advance compounds through the preclinical and clinical pipeline. This position will involve the design, execution, and interpretation of nonclinical toxicology studies to support regulatory submissions and drug development. Please note this is an on-site opportunity.

Key Responsibilities

• Design, oversee, and interpret nonclinical toxicology studies (GLP and non-GLP) to evaluate the safety profile of drug candidates.
• Collaborate with CROs to ensure proper execution and quality of toxicology studies, including general toxicity, reproductive toxicity, genotoxicity, and carcinogenicity studies.
• Provide toxicological expertise to guide candidate selection and optimize dosing regimens for preclinical and clinical studies.
• Interpret toxicology and pathology data, assess risk, and provide safety margins to inform decision-making.
• Contribute to the preparation and review of regulatory documents, including CTA/INDs, IBs and NDAs/BLAs.
• Represent the company in discussions with regulatory agencies regarding toxicology-related issues.
• Stay current on toxicology guidelines and regulatory requirements (e.g., FDA, EMA, ICH).
• Collaborate with internal teams (e.g., pharmacology, pharmacokinetics, clinical development) to provide integrated safety assessments.
• Contribute to nonclinical development plans and strategy to ensure alignment with program goals.
  
  

Minimum Requirements

• Ph.D., D.V.M., or equivalent degree in Toxicology, Pathology, Pharmacology, or a related field.
• 8-10 years experience in nonclinical toxicology within the pharmaceutical or biotechnology industry.
• Strong understanding of GLP regulations, study design, and toxicological evaluation of small molecules, biologics, or other modalities.
• Experience interpreting toxicology and pathology data and providing actionable safety assessments.
• Demonstrated ability to manage CROs and oversee outsourced toxicology studies.
• Excellent communication, writing, and presentation skills for cross-functional collaboration and regulatory interactions.
• Familiarity with regulatory guidance (e.g., ICH, FDA, EMA) and experience contributing to regulatory submissions.
• Demonstrated ability to work successfully in a fast-paced and dynamic work environment, with the agility to quickly pivot in the face of new data and/or strategic directions.
• Attention to detail and quality, and ability to deliver work on time.
  
  

Preferred Qualifications

• DABT (Diplomate of the American Board of Toxicology) certification or equivalent is highly desirable.
• Experience with novel therapeutic modalities (e.g., oligonucleotides).
• Expertise in predictive toxicology or computational toxicology is a plus.
• A forward-thinking mindset who can creatively leverage advancements in toxicological research, emerging technologies, and translational insights to anticipate and mitigate safety risk.
  
  

City Therapeutics is accepting resumes/CVs from direct applicants only. Recruitment Agency submissions will not be accepted at this time.

City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.