Senior Medical Director, Principal Patient Safety Physician - Oncology
Job details
Senior Medical Director, Principal Patient Safety Physician - Oncology Location: Luton UK (3 days on site) Do you have expertise in and a passion for Patient Safety? Would you like to apply your expertise to provide medico-scientific and clinical strategic leadership in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. Working with one of the broadest and deepest Oncology pipelines in the industry offers the possibility to work on the most novel molecules at all development stages. It takes each of us challenging our thinking to keep pushing our pipeline forward and shape the future of Oncology. What you'll do As a Senior Medical Director, Patient Safety Physician, you are a senior leader within Patient Safety and play a key role bringing deep clinical understanding and judgement in benefit risk assessments for AstraZeneca products. You will also ensure projects adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements. Your duties and responsibilities are likely to include:
- Providing strategic Patient Safety input to drug development and post-marketing programs.
- Collaboration with team members to undertake safety surveillance activities and prepare high quality evaluation documents to describe safety findings.
- Ensuring expert input to all elements of design and interpretation, including efficient use of tools and methodology (e.g. modelling and simulation).
- Providing leadership to support project discussions with governance boards, including interactions with Patient Safety Peer Review Committee.
- Lead the safety strategy for regulatory communication and provide oversight of higher-level documents to support submission activities.
- Lead medico-scientific contributions to RMPs for assigned products and to Periodic Reports, including PBRERs, DSURs.
- Degree in medicine and experience as a physician or academic clinician.
- Extensive experience in Pharmacovigilance, with clear evidence of delivering to a high standard.
- Detailed understanding of pharmaceutical safety, reporting and surveillance processes and strong experience of Patient Safety, as it relates to clinical trials and marketed products in any relevant field such as pharma, Regulatory Agency or Public Health agency.
- Experience in designing, monitoring and implementing clinical trials and interpreting trial results.
- Strategic leadership of complex drug projects.
- Understanding of the medico-legal aspects of pharmacovigilance.
- Shown leader of cross-functional delivery teams.
- Demonstrated ability to influence key business partners within and outside of the company.
- Proficiency with both written and verbal communications.
- PhD in scientific field.
- Therapeutic area expertise and commercial understanding.
- Extensive general medical knowledge.
- Able to work across TAs and Functions.
- Research background, including peer reviewed publications.
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