Job Abstract

At AstraZeneca we are dedicated to being a Great Place to Work and creating an environment where you are empowered to help push the boundaries of science and unleash your entrepreneurial spirit! There is no better place to make a difference to medicine, patients, and society. We are an inclusive culture that champions diversity and collaboration and we are committed to lifelong learning, growth, and development.

Global Patient Safety at AstraZeneca protects people's health by identifying, predicting, and preventing adverse effects in our medicines. Our team is changing, and we are building a global team passionate about patient safety in the drug development process.

The Hepatic Clinical Safety Knowledge Group (SKG) Lead manages a diverse range of activities related to monitoring, diagnosis, and mitigation of drug/biological-induced organ toxicity in a matrix environment. The role holder encourages, manages, and leads cutting edge drug/biological-induced liver toxicity projects on a global basis. The SKG Lead will be influencing the shaping of the organisation by providing strategic direction and applying a full understanding of global issues related to drug/biological-induced liver toxicity. The role impacts the entire function and the broader AZ organization.

Responsible for managing global or regional therapeutic/ research projects or acting as an expert involved in the design, conduct, monitoring, data interpretation and reporting of individual clinical trials. Ensures projects adhere to Good Clinical Practice and regulatory requirements. Will be responsible for overseeing development of the functional strategy or act as renowned expert in own field.

• Acts as an expert involved in the design, conduct, monitoring, data interpretation and reporting of potential clinical safety signals related to liver toxicity which arise during the conduct of clinical trials.
• Drives scientific research around drug-induced liver injury, having a strong presence at internal and external conferences, and delivering key scientific publications
• Manages global collaborative research projects for state-of-the-art detection, management, and mitigation of clinical safety signals related to organ toxicities
• Ensures the research projects related to drug-induced organ toxicity adhere to Good Clinical Practice and regulatory requirements.
• Acts as renowned expert in liver safety to provide expert scientific and medical input to Patient Safety activities, with special focus on cross-project and cross-TA activities of a scientific nature
• Promotes safety sciences and clinical safety across projects and therapeutic areas
• Leads and contributes to key cross-industry activities around drug-induced liver injury research, such as research consortia
• Contributes to improved understanding and prevention of drug/biological-induced organ toxicity issues across functions within the company and across Pharmaceutical Companies and Regulatory Authorities.
• Lead initiatives to increase cross-company knowledge of drug-induced liver injury through training and other activities
• Expert speaker on drug-induced liver injury at external conferences
• Leads the drug/biological-induced organ toxicity biomarker development and preclinical strategies
• Represents Patient Safety as a Data monitoring committee / safety committee member
• Drives projects to improve visualisation and presentation of liver safety data

• Medical degree with strong clinical experience
• Specialty training and/or board certification in a relevant speciality (e.g. hepatic medicine/surgery, clinical pharmacology)
• 5 years of drug development/safety experience, including a product safety lead role
• Experience in safety data analytics and visualisation of liver safety data (such as through Spotfire or R analytics programmes) including experience of hepatotoxicity signal detection.
• Ability to balance business and clinical research objectives
• Experience working with regulatory agencies, preparing regulatory documents and overseeing submissions.
• A detailed knowledge of the pharmaceutical industry, especially clinical research and global regulatory requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities
• Proven high quality scientific track record

• Extensive general medical knowledge and academic/research experience
• Demonstrated capability to lead implementation of new technology and/or working routines within a sophisticated organization.
• Drug development / safety experience across therapeutic areas, including Oncology
• Experience of acting as a Data Monitoring Committee safety representative / experience of setting up a Data monitoring committee
• Proven track record in leading in a cross- industry project or consortia
• Publications in safety-related scientific research
• Strong team-working skills and an ability to work collaboratively in a global pharmaceutical environment
• Strategic thinking
• Strategic influencing

With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society.

Are you ready to bring new ideas and fresh thinking to the table? Great! We have one seat available, and we hope it’s yours.

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