Associate Medical Director, Patient Safety Physician, Cell Therapy – Long-Term Follow-Up (LTFU)

Do you have expertise in, and passion for Patient Safety in 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 an Associate Medical Director, Patient Safety Physician, Cell Therapy Long-Term Follow-Up (LTFU), you will be a leader within the Cell Therapy Patient Safety Unit (CTPSU) and play a key role bringing deep clinical understanding and judgement in long term benefit risk assessments for AstraZeneca cell therapies in 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 Long Term 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 long-term follow-up (LTFU) 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 LTFU safety signal validation. 

• Ensuring expert input to LTFU 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 cell therapy LTFU strategy for regulatory communication and provide oversight of higher-level documents to support submission activities for assigned studies/products.