Kelly Science and Clinical is seeking a Senior Director, In Vivo Gene Editing Discovery for our client in Boston, MA
 

Position Summary

Reporting to the CSO, the Senior Director, In Vivo Gene Editing Discovery will serve as a scientific advisor and lead teams of scientists in the design of project strategies and plans based on understanding of intended indications, patient populations, and endpoints, gleaned through cross-functional interactions with clinical, nonclinical, and translational collaborators. The successful candidate must have a proven track record in the discovery and development of drugs targeting diseases of non-CNS/peripheral tissues, including liver, at least through IND, with more than one modality including biologics, small molecules, nucleic acid-based, or gene therapy products; and possess a solid understanding of FDA/EMA guidelines.

Key Responsibilities:

As the Senior Director, In Vivo Gene Editing Discovery, you will be responsible for:

• Leverage drug development experience and subject matter expertise in peripheral indication space to guide target identification evaluations, prioritizations, and the development of project strategies with a robust chain of translatability from research to clinic.
  

• Serve as a scientific advisor to project teams for operational planning, including timelines and deliverables, and engage and align stakeholders across functions to enable advancement of Editas’ pipeline of in vivo medicines.
  

• Lead efforts from early discovery to development candidate nomination, and support thereafter to fulfill needs of development program, e.g., regulatory filings, input to biomarker plan.
  

• Manage and mentor a diverse team of scientists to build their competencies in drug development, and strategic development of project plans.
  

• Develop cross-functional lines of communication to promote workstreams, and mentor project leads to develop lines of communication for coordinating project work with functional stakeholders and to manage CROs and collaborators as needed.
  

• Manage CROs, academic collaborators, and KOLs.
  

• Establish SOPs, write prospective protocols, author study reports and regulatory documents, assist patent filing, and contribute to business development activities.  
  

• Serve as a technical and scientific resource for junior staff.
  

• Manage diverse team interactions. Be a dedicated people manager to positively influence our culture.

Requirements

The ideal candidate will possess:

• Ph.D. with minimum of 15 years of working experience, including proven track record in the discovery and development of drugs for diseases of peripheral tissues/organs in the pharmaceutical and/or biotechnology industry, substantiated by publications, patent filings, and/or other, from tenure in drug discovery and development as characterized.
  

• Subject matter expertise in disease(s) of peripheral indication space as demonstrated by publications and/or track record is highly desirable.
  

• Working experience with lipid nanoparticles for targeted delivery in vivo is highly desirable.
  

• Familiarity with FDA and EMA guidance for cell and gene therapy and experience with IND-filing.
  

• A minimum of five years managerial experience that demonstrates effective leadership in a cross-functional setting.

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