Mechanistic Pharmacology Specialist
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Job Description
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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.
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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.
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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.
Employment Type
Full Time
Department / Functional Area
Doctor / Nurse / Paramedics / Hospital Technicians / Medical Research
