Director Physician, Hepatic SKG expert

The Clinical expert in the Hepatic Safety Knowledge Group (SKG) manages a diverse range of activities related to monitoring, diagnosis, and mitigation of drug/biological-induced hepatic toxicity in a matrix environment. The role holder leads or contributes to cutting edge drug/biological-induced liver toxicity projects on a global basis. The Clinical expert in the Hepatic SKG will be influencing the shaping of the organisation by inputting into 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 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 contributing to the development of the functional strategy or act as renowned expert in own field.

Main Duties and Responsibilities:

• 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.
• Contributes to scientific research around drug-induced liver injury, having a strong presence at internal and external conferences, and delivering key scientific publications
• Contributes to global collaborative research projects for state-of-the-art detection, management, and mitigation of clinical safety signals related to liver 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
• Leads or contributes to the development of scientific methods applied to a wide range of safety data related to drug-induced drug/biological induced liver toxicity
• Works with relevant stakeholders to enhance visualisation and presentation of liver safety data
• Provides support, as needed, for discussions with internal governance and international regulatory bodies
• Leads or 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 liver 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
• Works as part of a cross functional team in drug/biological-induced organ toxicity biomarker development and preclinical strategies
• Promotes safety sciences and clinical safety across projects and therapeutic areas

Essential Requirements:

• Medical degree with strong clinical experience in hepatology
• Specialty training and/or board certification in a relevant speciality (e.g., hepatic medicine/hepatic surgery)
• > 3 years of clinical development/patient safety experience in industry, or other relevant experience
• Experience in leading or contributing to relevant development programmes (e.g., those in liver disease, or developing products with liver safety signals)
• Experience working with regulatory agencies, preparing regulatory documents and overseeing submissions.
• Highly developed levels of conceptual thought and strategic vision to manage the highest level of risk.
• Ability to balance business and clinical research objectives
• A thorough knowledge of the pharmaceutical industry, especially clinical research, safety 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
• Excellent verbal and written communication skills
• Experience in leading of cross-functional teams
• Broad knowledge of drug development

Desirable Requirements:

• Extensive general medical knowledge and academic/research experience
• Experience of being a member of a company Hepatic Safety expert group (or similar), assessing liver cases for causality across a range of products
• 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.
• Demonstrated capability to lead implementation of new technology and/or working routines within a complex organization.
• Drug development / patient safety experience across therapeutic areas, including liver diseases or Oncology
• Proven ability 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

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.