Associate Director, Preclinical Development

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Job description

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

Why join Life Edit and the ElevateBio ecosystem?

Life Edit Therapeutics is an integrated subsidiary of ElevateBio, a technology-driven cell and gene therapy company that is accelerating access to the cutting-edge technologies and expertise that can change the future of medicine. Our integrated model combines multiple R&D technology platforms - including Life Edit gene editing - and cGMP manufacturing to power the discovery and development of advanced therapeutics. Our ecosystem is designed to enhance speed, delivery, and probability of success to change patient lives.

Life Edit is an integral part of ElevateBio's ecosystem of platform technologies and is pioneering focused next-generation gene editing technologies and therapeutics. Located in Durham, NC, members of Life Edit work closely with the ElevateBio Research and Development and BaseCamp manufacturing teams in Waltham, MA. Life Edit is advancing therapeutic programs in collaboration with industry partners while building its own internal pipeline of gene editing therapies. We are looking for a unique individual who can continue to lead the cultural development of Life Edit and build on its momentum as an integral part of the ElevateBio ecosystem.

Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision:
We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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