Senior/Principle Toxicologist

Cambridgeshire, England
Oct 13, 2016
Nov 10, 2016
Medimmune UK
Result Type
Position Type
Full Time

Senior/Principal Toxicologist

Salary: Competitive

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. At MedImmune our employees make up a diverse and modern workforce. Our culture is defined by a strong sense of collaboration. We believe in rewarding talent and performance, and pride ourselves on being a great place to work.

Within the Biologics Safety Assessment (BSA) department, Toxicology project leaders (TPLs) at the Senior or Principal Toxicologist level are key functional representatives to Research Project and Product Development Teams, contribute to the creation of overall drug development plans, and are accountable for the delivery of the nonclinical safety assessment component of these plans, ensuring appropriate strategies and toxicological interpretations are provided to meet business objectives. The successful applicant will be based in Cambridge, UK.

If successful you will be responsible for the development of appropriate strategies to assess nonclinical safety of MedImmune assets across therapeutic areas, with an emphasis on immuno-modulatory products, in particular immuno-oncology products. This includes but is not limited to: designing pharmacokinetic/pharmacodynamic (PK/PD) and toxicology studies and actively contributing to inclusion of pharmacodynamic readouts in these studies; organising, planning and monitor emerging data from in vivo toxicology studies in collaboration with study monitors; oversee the delivery of reviewed and approved final toxicology study reports, contribute to regulatory documents (CTAs, IMPDs, INDs, BLAs, etc) and be involved in interactions with regulatory authorities as needed. Moreover, you will communicate toxicology data internally and to Research Project and Product Development Teams, ensuring delivery in line with the business objectives and attend and/or present at relevant governance committees.

Essential Requirements

  • PhD degree in a relevant subject area
  • Good understanding of the principles of toxicology testing of small molecules and biologics and relevant regulatory guidelines
  • Extensive experience with managing CRO-based toxicology studies in all common toxicology species
  • Understanding of toxicological mechanisms as the basis of developing safe medicines
  • Experience with acting as nonclinical safety representative in early stage (lead optimisation-IND) project teams within the pharmaceutical industry
  • Experience with preparing and submitting regulatory documentation (CTA/IND, briefing documents) and regulatory interactions
  • Understanding of pharmacokinetics and PK/PD relationships

Desirable Requirements

  • Other relevant professional qualifications or recognition, e.g. DABT/ERT
  • Experience with acting as nonclinical safety representative in mid-to late stage (PhII/III) project teams
  • Knowledge of the mechanistic basis of disease processes in humans and animal models of disease
  • Understanding of the drug development process for biologics
  • Understanding of CMC for biologics

Closing date: November 30th 2016

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.