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Permanent Positions

Toxicology Project Leader / Associate Director – Non Clinical Safety Evaluation
Cambridge, East Anglia

Our Client has a  new vacancy in there expanding Non-Clinical Development team for an experienced individual to take responsibility for the management of non-clinical Toxicology programmes to support progression of biopharmaceutical drug candidates into the clinic and beyond.

Key responsibilities:

  • To plan, design and implement non-clinical development programmes for multiple projects targeting multiple disease indications (eg immuno-oncology and haematology) and be accountable for interpretation and communication of safety findings and delivery of regulatory-compliant non-clinical PK/PD and safety studies
  • To identify appropriate external contractors or service providers for each work package, define study protocols, manage studies, interpret study findings and review reports (in association with the Non-Clinical Study Manager where appropriate) in order to meet agreed project milestones and business objectives
  • To represent non-clinical safety on Development Project Teams and to communicate progress, identified risks and issues arising on non-clinical studies
  • To author non-clinical safety sections of regulatory documents to support successful IND or CTA filings
  • To prepare target safety reviews and risk assessments for novel targets and to support drug development from early lead optimization all the way through to registration
  • To design and implement investigative mechanistic studies, as required, to further investigate any non-clinical findings
  • To keep up-to-date with relevant regulatory guidance and industry best-practice requirements applicable to GLP non-clinical studies

Key requirements:


  • BSc and preferably a higher degree in a relevant biological discipline
  • Significant experience of biopharmaceutical safety testing either in the pharmaceutical industry or within a CRO environment
  • Proven track record of working with CRO’s
  • Excellent communication and management skills


  • Working knowledge of current GLP and ICH guidelines as they relate to the non-clinical evaluation of biologics
  • Highly organised, able to prioritise work, work well under pressure and meet deadlines
  • Ability to work in a flexible, collaborative style with colleagues and teams within the company, as well as with external advisors, service providers and collaborators including consultants, CROs and partners in strategic R&D collaborations

To proceed with your application for this role, simply apply to this advert, or alternatively you can send you’re most recent up to date CV to

Please note, only successful candidates will be contacted. All successful applications are subject to S3 Science’s stringent vetting and security checks.

S3 Science is proud to be an equal opportunities employer and is committed to creating a diverse environment. All qualified applicants will receive consideration for employment without regard to race, colour, religion, gender identity or expression, sexual orientation, national origin, genetics, disability, age or veteran status.

Salary: 60,000 - £80,000
Date Posted: 13/03/2018
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