Medical Director, Senior Patient Safety Physician, Cell Therapy - Oncology

Do you have expertise in, and passion for Patient Safety in Oncology or Haemato-Oncology? 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 innovative 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 commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies. Working with one of the broadest cell therapy pipelines in the industry offers the possibility to advance the most novel Cell and Gene Therapy (CGT) technologies at all development stages across multiple indications. It takes each of us to challenge our thinking to keep pushing our pipeline forward and shape the future of cell and gene therapies. 

As a Medical Director, Senior Patient Safety Physician, Cell Therapy Oncology, you will report to the Cell Therapy Oncology Global Safety Project Lead (GSPL). You will be a senior leader within the Cell Therapy Patient Safety Unit (CTPSU) and play a key role bringing deep clinical understanding and judgement in benefit risk assessments for AstraZeneca cell therapies in oncology and/or haemato-oncology. You will also have a role in shaping the culture of the department and will act as a coach and mentor to more junior Patient Safety staff. You will ensure processes adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements as well as AZ processes. 

Main Role Responsibilities: 

• Providing strategic Patient Safety input to CGT drug development programs as part of a global matrix team with high-quality contribution to Safety & Strategy Management Team (SSaMT) deliverables 

• Responsible for safety contribution to study designs and study concept delivery within their assigned study/program 

• Collaboration with PS team members to undertake safety surveillance activities and prepare high quality evaluation documents to describe safety findings including safety signal validation. 

• Ensuring expert input to safety-relevant elements of study design and interpretation, including efficient use of digital/ artificial intelligence (AI) tools and methodology (e.g. adverse event visualisation and disproportionality analysis. 

• Providing leadership to support project discussions with governance boards, including interactions with Patient Safety Review Board. 

• Leading the safety strategy for regulatory communication and provide oversight of higher-level documents to support submission activities for assigned studies/products. 

• Leading medico-scientific contributions to risk management plans (<