Associate Director, Preclinical Development

The Role:

 Life Edit is looking for an experienced Preclinical Development professional with strong organizational communication, and strategy skills, and the desire to be part of a highly collaborative and cross-functional team. The applicant will lead the preclinical development activities (pharmacology, immunology, and safety) for the LifeEdit’s gene editing therapeutic programs. The applicant will manage a team of preclinical scientists and be responsible for running preclinical development across multiple programs. This position offers an exciting opportunity to contribute to the preclinical development of a variety of gene editing products and to impact Life Edit’s therapeutic strategy. Experience in developing preclinical packages for IND submission is highly desired, with working knowledge of AAV and/or LNP delivery systems.

Here’s What You’ll Do:

• Define the strategy, experimental design, and assays to evaluate gene editing therapeutic candidates using clinically relevant models
• Identify clinically meaningful fluid- and imaged based biomarkers
• Design and manage preclinical studies (non-GLP and GLP) for inclusion in IND and BLA submissions, including pharmacology, biodistribution, immunology, and toxicology studies with estimated costs, timing, and risk assessment/management
• Select and manage CROs to support preclinical development programs
• Work closely with other functional areas and colleagues to ensure that all studies are performed in a quality, timely, scientific, and regulatory ready research manner
• Write, review, and edit preclinical study protocols, reports and sections for IND and BLA submissions
• Manage preclinical scientist direct reports
• Communicate study findings, including relevance and interpretation, to project teams
• Interact with regulatory agencies on preclinical matters
• Maintains a current understanding of safety literature and methodology, related to gene therapy and gene editing
• Maintains a current understanding of regulatory requirements, guidelines, and strategy

Requirements:

• PhD in Biological Sciences, Toxicology, Pharmacology or related life sciences field with strong scientific background and 10+ years’ relevant experience with minimum 5 years working in industrial pharmaceutical toxicology/safety assessment drug development
• Good understanding of analytical/bioanalytical measurement techniques and methodology
• Ability to synthesize and interpret diverse, multidisciplinary data sets
• Experience participating on drug development teams and IND submissions
• Experience in designing, monitoring, and interpreting preclinical safety studies
• Strong knowledge of preclinical drug development and FDA and ICH guidance documents including GLP regulations for preclinical studies with biologics is essential
• Experience managing direct reports, CROs, and collaborating with project teams
• Ensure appropriate use of animals in compliance with the 3Rs: Replacement, Reduction and Refinement
• Team player, detailed oriented, and outstanding organizational and communication skills (verbal, presentation and written)

Preferred Qualifications:

• Experience with AAV and/or LNP delivery systems strongly preferred
• Experience with gene therapy and/or gene editing
• Industry experience