Mechanistic Pharmacology

2 weeks ago

Amman, Jordan AstraZeneca Full time

  • You’ll be working with many different modalities beyond classical biopharmaceuticals, so you’ll need to be creative and work in areas where there are no pre-defined solutions, utilising the best capabilities within and outside AstraZeneca.

    Your main tasks will include:

  • Design and interpret fit for purpose safety pharmacology packages and guide projects with tangible, quantitative risk assessments that underpin science-driven decisions.
  • Develop patient-centric safety pharmacology risk assessment strategies applicable to novel therapeutic modalities, where conventional approaches may not be appropriate or possible.
  • Author non-clinical safety pharmacology sections of regulatory submission documents and engage with regulatory authorities to secure approval of IMPD/IND and MAA/NDA submissions.
  • Extend the Safety Pharmacology beyond the boundaries defined by ICH S7A and S7B and shape the discipline externally with publications, collaborations and involvement in consortia.

  • Essential in the role:

  • Extensive experience in pharmaceutical development, with a PhD (or equivalent experience) in pharmacology, toxicology, pathology or a related Natural Science field.
  • Experience of Safety Pharmacology in drug discovery and development, with exposure to non-clinical safety assessment in a project setting.
  • Experience with nonclinical regulatory submissions and health authority interactions
  • Demonstrable expertise in the design and interpretation of in vitro and in vivo studies, translating scientific findings into applicable information in a drug development environment.
  • Familiarity with pharmacokinetic-pharmacodynamic and systems pharmacology approaches.
  • Validated ability to run a large portfolio of projects including prioritize activities in a matrix environment.
  • Understanding of the external factors that shape the scientific and regulatory landscapes relevant to Safety Pharmacology.
  • Proven strong scientific track record and problem-solving capabilities.

  • We also believe that the successful candidate should have high ability to communicate and present your work in a natural and clear way and enjoy working across multi-disciplinary teams with efficiency.

    Desirable in the role:

  • In depth knowledge of cardiac function, ECG and imaging modalities.
  • Diplomat of Safety Pharmacology, DABT or ERT accreditation.