Principal Patient Safety Physician - Oncology
Competitive Salary & Benefits
At AstraZeneca when we see an opportunity for change we seize it and make it happen, because an opportunity no matter how small can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential.
Our ambition is to push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer.
To accomplish this, we focus on research & development and our commercial capabilities to deliver a new generation of medicines that have the potential to redefine cancer treatment.
As a Principal Patient Safety Physician, you play a key role bringing deep clinical understanding and judgement to the patient safety risk perspective in benefit risk assessments. You will also ensure projects adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements. The role will be based in our Cambridge City House office, close to Cambridge Train Station.
Main Duties and Responsibilities
You will provide medico-scientific and clinical strategic leadership for assigned product(s). You will provide Disease Area strategic Patient Safety input to drug development and post-marketing programs across life-cycle of assigned substances and products – e.g to dTPPs, patient populations, scientific understanding of toxicity-related mechanisms, ensure risk management commitments, risk mitigation and communication. You will define safety needs of Oncology TA disease areas with CoE and assure SSaMT interactions with PS Peer Review and SIRC. You will also lead regulatory communication and provide oversight of higher-level documents. We encourage you to closely follow medical developments within assigned areas to transform emerging data and trends into new plans
You will lead medico-scientific and clinical contributions to RMPs for assigned products and to Periodic Reports including PBRERs, DSURs, etc. You will also coach and mentor junior Patient Safety staff and support SSaMTs in relevant Product teams. You may lead SSaMTs for key products in phase III/early launch phase.
- Establish and lead SSaMT in accordance with PS Operating Model
- Agree SSaMT strategy and plan with GML, GCL and PSTAVP TA.
- Ensure SSaMT delivery of all elements of agreed plan to next project achievement, input to governance decisions and strategy to next achievement
- Ensure expert input to all elements (including SKGs) of design and interpretation, and efficient use of available tools and methodology (e.g. modelling and simulation)
- Establish and represent the “safety view” of the assigned program(s) internally and externally
- Degree in medicine and experience as a physician or academic clinician
- Extensive experience in designing, monitoring and implementing clinical trials and interpreting trial results
- Significant experience in advanced research and development
- Experience from strategic leadership of complex drug projects
- Therapeutic area expertise and commercial understanding
- Meaningful industry experience in Pharmacovigilance field
- 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
- Understanding of the medico-legal aspects of pharmacovigilance
- Proven leader of cross-functional delivery teams.
- Demonstrated ability to influence key business partners within and outside of company
- Proven proficiency with both written and verbal communications
- PhD in scientific discipline
- Extensive general medical knowledge
- Able to work across TAs and Functions
- Research background including peer reviewed publications
Next steps? Apply now!
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 authorisation and employment eligibility verification requirements.