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.
