Associate Director (Preclinical Development) (Durham, NC)

• Define strategy and experimental designs for evaluating gene editing therapies using relevant clinical models.
• Identify fluid- and image-based biomarkers with clinical significance.
• Design and manage preclinical studies (both non-GLP and GLP) for IND and BLA submissions, including pharmacology, biodistribution, immunology, and toxicology studies. Provide cost estimates, timelines, and risk assessments.
• Select and manage CROs supporting preclinical programs.
• Collaborate across functional areas to ensure studies meet scientific, quality, and regulatory standards.
• Author and review protocols, reports, and sections for IND/BLA submissions.
• Manage and mentor preclinical scientists.
• Present findings and interpretations to project teams.
• Liaise with regulatory agencies on preclinical matters.
• Stay updated on gene therapy and gene editing safety literature, methodologies, and regulatory strategies.

• PhD in Biological Sciences, Toxicology, Pharmacology, or a related field with 10+ years of relevant experience, including 5+ years in pharmaceutical toxicology or drug development.
• Expertise in analytical/bioanalytical measurement techniques.
• Strong ability to analyze and interpret multidisciplinary data.
• Experience in drug development teams and IND submissions.
• Proven track record in designing, monitoring, and interpreting preclinical safety studies.
• In-depth knowledge of preclinical drug development, FDA, ICH guidelines, and GLP regulations.
• Experience managing CROs and direct reports, with cross-functional collaboration.
• Commitment to the 3Rs (Replacement, Reduction, Refinement) in animal studies.
• Excellent organizational, communication, and team collaboration skills.

• Experience with AAV or LNP delivery systems.
• Background in gene therapy and/or gene editing.
• Industry experience in gene therapy and editing drug development.

This is a full time position