Associate Director, Nonclinical Safety

Role Summary

Associate Director, Nonclinical Safety. Responsible for the creation and execution of the nonclinical safety strategy for therapeutic programs, both research and clinical stage, ensuring therapeutics are safe and studies are conducted in a timely manner, within budget and scope. This role will be part of both research and development teams and will be an active member of the Research Strategy & Operations team.

Responsibilities

• Sets the toxicology strategy for all programs
• Designs and manages nonclinical safety studies (GLP and non-GLP) suitable for IND/CTA/NDA/BLA submission
• Manages external contract research organizations (CROs) to support nonclinical development program studies
• Interacts with other internal functional areas to ensure that studies are performed in a quality, timely, and scientifically appropriate manner
• Generates and/or reviews nonclinical sections for IND/CTA/BLA submission
• Works with external collaborators on a range of disease models
• Participates in discussions with regulatory agencies to obtain feedback on nonclinical development programs
• Ensures compliance with regulatory guidelines
• Develops and oversees nonclinical safety and toxicology drug development plans with estimated costs, timing, and risk assessment/management
• Critically reviews and edits toxicology study protocols and reports, analyzes and interprets data, and coordinates report finalization for both contracted and internal studies
• Prepares and edits nonclinical documents for regulatory submissions (e.g. IND/NDA/BLA, IBs, and other regulatory briefing documents)
• Maintains a current understanding of toxicology literature and methodology, as well as scientific literature related to the specific drug discovery projects
• Maintains a current understanding of regulatory requirements and guidance
• Quarterly travel may be required

Qualifications

• Ph.D., M.D., or equivalent preferably in Toxicology/Pharmacology or Veterinary Medicine
• A minimum of 5-7 years in nonclinical development with emphasis on toxicology; experience with design, conduct, and interpretation of toxicity studies; experience in IND/CTA/NDA/BLA applications
• Experience in a research field related to Nonclinical Development, Toxicology, and Nonclinical Pharmacology
• Familiarity with GLP requirements and ICH guidelines; experience in management of external academic collaborations and CROs
• Proficient in scientific documentation supporting submissions to regulatory agencies
• Experience in the design, conduct, analysis, and interpretation of nonclinical studies
• Training in Animal Use Protocols as PI, or sponsor
• An excellent scientific/clinical background as demonstrated through publications in medical science journals
• Excellent verbal and written skills necessary for internal collaborations and engagement with regulatory agency bodies

Skills

• Nonclinical safety and toxicology development
• Study design and data interpretation
• Regulatory submission support (IND/CTA/NDA/BLA)
• GLP familiarity and ICH guidelines
• Project management and external CRO partnership
• Regulatory liaison and document preparation

Education

• Ph.D., M.D., or equivalent in Toxicology/Pharmacology or Veterinary Medicine

Additional Requirements

• Quarterly travel may be required