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Toxicologist

Toxicologist

  • Location

    Hertfordshire, England

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Denise Saab

  • Contact email:

    Denise.Saab@volt.eu.com

  • Job ref:

    75035-PHARM-DEB_1567697712

  • Published:

    about 2 months ago

  • Expiry date:

    2019-10-05

  • Start date:

    ASAP

  • Consultant:

    #

The Company's next-generation AAV gene therapy platform, we are seeking a scientifically and operationally strong Toxicologist with sound experience of early Phase translational research, who can lead CROs and external collaborators to deliver successful IND enabling studies supporting the company programmes.

ESSENTIAL REQUIREMENTS:

  • Strong scientific background in Pharmacology and Toxicology to address key pharmacologic scientific questions, advancing projects from pre-clinical to early phase clinical development

  • Strong understanding of and experience with GLP toxicity requirements across different territories (e.g. EU, USA)

  • Understanding of the necessary preclinical data for a lead candidate to support IND/CTA, coupled with experience of working in cross-functional teams to support pre-IND drug development.

  • Ability to represent the company and strong experience working with external providers such as contract research organisations (CROs) and academic specialty laboratories.

  • Ability to direct and assess the work of a CRO to produce a high standard of work for ex-vivo and in vivo experiments

  • Exceptional analytical and problem-solving skills, with the ability to understand and interpret findings and to develop mitigation strategies for the successful progression of projects.

  • Willingness to travel both within the United Kingdom and abroad to evaluate capability of CRO and academic speciality Laboratories, support Regulatory meetings, as well as to present at conferences/workshops and other meetings


QUALIFICATION, EDUCATION AND EXPERIENCE REQUIREMENTS

  • BSc in a relevant biological discipline or equivalent level of professional qualifications, with a minimum of 5 years of experience working in the pharmaceutical industry in a preclinical R&D environment

  • Experience with in vivo models in multiple species (rodent and non-rodent), as well as correlating in vitro/in situ systems with in vivo models

  • Has successfully led multiple GLP-toxicity studies, including protocol writing, study management and reporting

  • Excellent verbal and written communication and computer literacy skills, with the ability to write and present clearly and succinctly for regulatory documents, publication, for internal decision making

  • Personable and effective communicator, willingness to work as part of a multi-disciplinary team, to be open-minded, flexible and cooperative in a dynamic and fast-growing company

 

DESIRABLE SKILLS

  • Prior knowledge on the execution of preclinical AAV studies using various in vivo model systems related to AAV gene therapy development to deliver high-value data and support all aspects of AAV-based gene therapy projects.