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 a Medical Director, Senior Patient Safety Physician, Cell Therapy, 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. 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 (RMPs) for assigned products and to Periodic Reports, including PBRERs, DSURs. 

Authoring and accountable for the Safety-related aspects of the Target Product Profile (TPP) and internal Go/No-Go Investment Decisions (ID) for the CTG product throughout its lifecycle 

More broadly you are expected to participate in advisory discussions to support other Patient Safety teams in the development of their safety strategy and may be asked to represent Patient Safety in cross-functional discussions with internal and external partners. 

May be required to support in-licensing opportunities. 

Necessary Candidate Requirements: 

Medical Degree or equivalent. 

3+ years of proven clinical experience as a physician or academic clinician. 

Extensive experience in pharmacovigilance, with clear evidence of delivering to a high standard. Understanding of the medico-legal aspects of pharmacovigilance. 

Detailed understanding of pharmaceutical safety, reporting, and surveillance processes with strong experience of Patient Safety related to clinical trials and marketed products in any relevant field such as Pharmaceutical Industry, Regulatory Agency, or Public Health agency 

Experience in designing, overseeing, and implementing clinical studies with a focus on patient safety, including adverse event monitoring, safety data review, signal detection and evaluation, and interpretation of trial results to inform benefit–risk assessments and safety labeling. 

Documentable strategic leadership expertise is Patient Safety of complex drug programs 

Ability to collaborate across a matrixed environment and influence cross-functional leaders on decision-making. 

Demonstrated ability to influence key business partners within and outside of company 

Proficiency with both written and verbal communications 

Additional Preferred Expertise: 

Research experience in the GCT field 

Medical specialty, or documented training, in oncology and/or haemato-oncology 

5+ years of proven clinical experience 

Oncology therapeutic area expertise and commercial understanding 

Extensive general medical knowledge 

Able to work across therapeutic areas (TAs) and functions 

Experienced in using AI tools  

Basic and/or Translational Research background, including authoring peer reviewed publications 

Good knowledge of PV regulations in China, Australia, Japan, rest of Asia 

Why AstraZeneca? 

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. 

Where can I find out more? 

Our Social Media, Follow AstraZeneca on LinkedIn: 

 https://www.linkedin.com/company/1603/ 

Follow AstraZeneca on Facebook:  

https://www.facebook.com/astrazenecacareers/ 

Follow AstraZeneca on Instagram:  

https://www.instagram.com/astrazeneca_careers/?hl=en 

Next Steps – Apply today! 

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them 

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AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.