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Principal Scientist, Toxicology

Principal Scientist, Toxicology

  • Location

    Cambridge

  • Sector:

    Preclinical Development & Safety

  • Job type:

    Permanent

  • Salary:

    £140k - 170k per year

  • Contact:

    Jack Clay

  • Contact email:

    Jack.clay@catalystcareers.com

  • Contact phone:

    02035899300

  • Job ref:

    LM51906

  • Published:

    5 months ago

  • Expiry date:

    2020-05-05

My client is a medium sized biotech focussing within Immunology and Oncology. They are looking for a Principal Scientist who will lead all aspects of toxicology work for select nonclinical programs to enable drug candidates from research through development and IND enabling studies. The principal scientist will design, execute, and interpret nonclinical safety studies conducted in multiple species, and will be heavily involved in regulatory submissions and interactions with various health authorities as well as the internal clinical team. The successful candidate must have the ability to multitask and to function effectively in a fast-paced environment. Be capable of conducting work independently, but also capable of pulling in subject matter experts when necessary to lead the conversation. Will maintain extensive scientific awareness and presence in toxicology, publishes manuscripts and posters, presents at scientific conferences and other scientific forums. Engages with consultants and advisors in the field, as well as the scientific community at large.

RESPONSIBILITIES

 

  • In conjunction with program teams and the nonclinical sciences team, develop toxicology strategies and provide expert support to research and development projects
  • Collaborate on the design of non-GLP investigative and pharmacology studies to support development compounds, as needed
  • Review, summarize and integrate complex data sets across multiple disciplines
  • Manage the preparation and presentation of nonclinical safety data for project teams, portfolio management, internal /external partners and/or scientific groups
  • Provide strategic advice to project teams and senior management including evaluation of conclusions and potential impact of toxicology results on program and clinical/regulatory strategy
  • Lead finalization of toxicology reports and manage the tabular presentation of data in accordance with CTD format
  • Support the preparation of national and international regulatory submissions and interactions with health authorities and be capable of effective communications with regulatory authorities
  • Work closely with clinical to ensure toxicology support for clinical trial designs
  • Mentor junior members of the team by providing scientific input and leading by example
  • The qualified candidate will serve as a resource for the department and project teams, proactively keeping colleagues/leadership updated with industry trends.

 

MINIMUM EDUCATION/EXPERIENCE

  • PhD degree in a scientific discipline with 6+ years’ experience, or Master's degree in a scientific discipline, or equivalent with 10+ years’ experience
  • Experience as a nonclinical safety representative on project teams
  • Exceptional knowledge of GLP Regulations
  • Experience in working with contract research organizations
  • Experience in dealing with global regulatory agencies
  • Candidate must be adaptable to a dynamic work flow and must be highly collaborative