Gene Editing SME

ROLE SUMMARY

• Responsible for 1) delivery of robust high quality investigative, molecular and omics toxicology data, portfolio and regulatory support within the current gene editing and advanced gene therapy pipeline.
• Focus will be on enabling laboratory and portfolio support for gene therapy and translational gene editing platforms within the advanced gene therapy and early gene editing pipeline with collaborations across RUs and partner lines.
• Propose and deliver on Drug Safety R&D issue management, technology and strategic initiatives with focus on novel gene editing modalities and delivery systems.
• Review and analysis of internal and external data in support of in vitro-in vivo or nonclinical-clinical translation in the gene therapy and gene editing platforms.
• Effective communication and collaboration with local and global peers in DSRD, Research units and partner line

ROLE RESPONSIBILITIES

• Primary area of focus is to be the key subject matter expert focusing on all aspects relevant to gene editing and gene therapy technologies including but not limited to nucleases, mRNA, DNA template, nanoparticles, viral vectors, next generation sequencing, on-target and off-target integration and in vitro screens.
• Support gene editing and advanced AAV portfolio by developing modality specific development and regulatory strategies including responding to regulatory query by developing laboratory packages through partnership with investigative, molecular and omics labs.
• Participate in issue management teams and Drug Safety Team Lead (DSTL) within gene editing and gene therapy programs in development. This will involve leading projects and/or providing leadership to junior laboratory scientists and project leaders for projects and issues from early discovery to development.
• Delivery of robust, high-quality lab-based investigative toxicology, translational and biomarker data to support the development, validation and implementation of safety tools.
• Leading the recommendation and presentation at governance meetings for proposing new mechanistic aspects of editing technologies and issue management.
• Author and review protocols, reports to support regulatory submissions, to ensure scientific integrity, technical feasibility and assess resource demand
• Responsible for developing scientific strategies to improve the overall quality of the G-DITS discipline for work conducted internally and externally.

QUALIFICATIONS

• PhD or equivalent experience in biology, biochemistry, toxicology, pharmacology or related fields, with 12 years experience.
• Strong portfolio and laboratory experiences in AAV, gene editing platforms, ex vivo and in vivo delivery systems and deeper understanding of the complexities associated with therapeutic gene editing.
• Thorough understanding of on target, off target editing, solutions to improve genome editing efficiencies in target cells and to minimize off target effects will be critical to the success of this role.
• Ability to work in a team and mentor junior research staff.
• Excellent oral and written communication skills to enable presentation and publication of Scientific data and results.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Additional Job Information:

• Last Date to Apply: April 5, 2023
• Relocation support available
• Work Location Assignment:Flexible

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Relocation assistance may be available based on business needs and/or eligibility.

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Research and Development