Associate Director/Director, Nonclinical Gene Therapy Safety Assessment

JOB SUMMARY
 

We are seeking exceptional talent for our Nonclinical group focused on gene therapy. Associate Director/Director of Nonclinical Safety Assessment will be responsible for managing the nonclinical safety of all products in various stages of development. This position is a key member of the development team and will develop the strategic direction for the non-clinical program to successfully support the IND and BLA applications. In addition, in collaboration with the publications team they will ensure that we effectively communicate the key data developed in the nonclinical program as appropriate.

RESPONSIBILITIES
 
  • Generate safety assessment development plans for products in the portfolio

  • Serve as the toxicology representative on assigned program teams, author nonclinical safety risk assessment documents for clinical programs and regulatory submissions (INDs, CTAs, NDA, MAA, IBs, DSURs, etc)

  • Work closely with Contract Research Organizations (CROs) on study protocols, ongoing status of studies, monitor critical phases as needed, and review key findings from studies

  • Review toxicology study reports to generate quality reports for regulatory submissions

  • Identify and work with expert consultants depending on project specific needs

  • Effectively communicate with project teams, senior management, and regulatory agencies as needed

  • Conduct due diligences and perform gap analyses on compounds for potential in-licensing opportunities.

QUALIFICATIONS
 
  • PhD or DVM preferred, or commensurate with experience

  • Board certification in toxicology (DABT) preferred

  • 5-10 years pharmaceutical industry, with knowledge and experience in aspects of drug development

  • Experience with gene therapies preferred

  • Proven ability to manage multiple projects/tasks at one time

  • Excellent written and oral communication skills

  • Broad knowledge of pharmaceutical toxicology and its related disciplines (e.g. DMPK, pharmacology) and nonclinical drug development (e.g. Manufacturing, Clinical, Regulatory)

  • Knowledge of drug development and life cycle management concepts and interdependencies with the overall development process

  • Experience as a nonclinical safety assessment project team member on a drug development team

  • Experience writing the nonclinical safety assessment portions of an IND/CTA and IB

PERSONAL ATTRIBUTES
 
  • Highly motivated self-starter with an entrepreneurial spirit

  • Desire to work in a quickly changing, fast-paced environment

  • Unrelenting dedication to delivering quality results

  • Integrity, in word and action

  • Willingness to roll up your sleeves to get the job done

Agencies/Recruiters

 

We maintain a list of approved professional recruiting agencies with which we have signed agreements. Candidates will be considered only when the agency has a signed agreement and Human Resources authorization to present candidates for a specified position(s). Candidates submitted outside of this process are considered unsolicited and will not be considered. Agencies interested in establishing a relationship with Axovant may send company information to careers@axovant.com. A member of the Human Resources team will contact you if we require the services your company offers.

AXOVANT GENE THERAPIES

Eleven Times Square, 33rd Floor
New York, NY 10036
United States

+1-833-AXOVANT (1-833-296-8268)

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AXOVANT SCIENCES GMBH

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