Senior Director, Hepatology Safety Center of Excellence

4 weeks ago

Waltham MA, United States AstraZeneca Full time

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.Typical AccountabilitiesActs 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 publicationsManages global collaborative research projects for state-of-the-art detection, management, and mitigation of clinical safety signals related to organ toxicitiesEnsures 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 naturePromotes safety sciences and clinical safety across projects and therapeutic areasLeads and contributes to key cross-industry activities around drug-induced liver injury research, such as research consortiaContributes 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 activitiesExpert speaker on drug-induced liver injury at external conferencesLeads the drug/biological-induced organ toxicity biomarker development and preclinical strategiesRepresents Patient Safety as a Data monitoring committee / safety committee memberDrives projects to improve visualisation and presentation of liver safety dataCrucial RequirementsMedical degree with strong clinical experienceSpecialty 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 roleExperience 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 objectivesExperience 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 activitiesProven high quality scientific track recordDesirable SkillsExtensive general medical knowledge and academic/research experienceDemonstrated capability to lead implementation of new technology and/or working routines within a sophisticated organization.Drug development / safety experience across therapeutic areas, including OncologyExperience of acting as a Data Monitoring Committee safety representative / experience of setting up a Data monitoring committeeProven track record in leading in a cross- industry project or consortiaPublications in safety-related scientific researchStrong team-working skills and an ability to work collaboratively in a global pharmaceutical environmentStrategic thinkingStrategic influencingWhy AstraZenecaWith 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.So, what’s nextAre you ready to bring new ideas and fresh thinking to the table? Great We have one seat available, and we hope it’s yours.Where can I find out moreOur Social Media, Follow AstraZeneca on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram Date Posted09-May-2024Closing DateOur mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.SummaryLocation: US - Gaithersburg - MD; Sweden - Gothenburg; UK - Luton; US - Waltham - MAType: Full time

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