Senior Director Physician, Cardiovascular Safety Knowledge Group Expert, AZ ECG Centre Cardiologist

<p>The Senior Director Physician job in the Cardiovascular Safety Center of Excellence and SKGs involves two roles: Cardiologist at the AZ ECG Centre (delivering the cardiology, scientific and operational tasks in the ECG Core Laboratory) and Cardiovascular Safety Knowledge Group Expert in the CV Safety Knowledge Group (CV SKG), advising drug/biologics teams on issues related to <span>drug/biologics-induced</span> CV toxicity. The clinical Cardiovascular Safety Knowledge Group (CV SKG) Expert manages a diverse range of activities related to monitoring, diagnosis, and mitigation of <span>drug/biologics-induced</span> cardiovascular toxicity in a matrix environment. The role holder inspires, manages, and leads cutting edge <span>drug/biologics-induced</span> CV toxicity projects on a global basis. The CV SKG Expert will be influencing the shaping of the organisation by providing strategic direction and applying a full understanding of global issues related to <span>drug/biological-induced</span> CV toxicity. The role impacts the entire function and the broader AZ organization.</p><p>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.</p><p></p><p><b>Responsible:</b></p><p></p><p>The Cardiologist at the AZ ECG Centre Role:</p><p>· Provides cardiology, scientific, author and reviewer contributions to development of clinical study documents (Study</p><p>Synopses, Clinical Study Protocols, Statistical Analysis Plans and outputs, and Clinical Study Reports)</p><p>· Delivers digital ECG data review and interpretation in clinical studies where the AZ ECG Centre delivers ECG Corelab</p><p>services and provides second opinion on the observed ECG/Arrhythmia/Vital Signs and other CV findings of clinical or</p><p>drug safety concern to Project Teams/ Investigators, when requested.</p><p>· Supervises and mentors ECG Scientific Advisors</p><p>· Provides expert contribution to the development, testing and validation of new methodologies for ECG and Holter</p><p>signals analysis.</p><p>· Provides expert contribution to the development, testing and validation of new methodologies for blood pressure</p><p>recording</p><p>· Provides expert contribution on applicability of new CV devices, connected devices and wearable CV digital devices in</p><p>AZ clinical trials.</p><p>· Provides expert advice on the choice and use of appropriate CV Imaging techniques, other laboratory techniques and</p><p>safety cardiac biomarkers, to optimize CV safety and to prevent CV toxicity in clinical trials.</p><p></p><p>The Cardiovascular Safety Knowledge Group Expert Role:</p><p>· Acts as an expert involved in the design, conduct, monitoring, data interpretation and reporting of potential clinical</p><p>safety signals related to CV toxicity which arise during the conduct of clinical trials.</p><p>· Manages global research projects for state-of-the-art detection, management, and mitigation of clinical safety signals</p><p>related to CV toxicities</p><p>· Ensures the research projects related to drug-induced CV toxicity adhere to Good Clinical Practice and regulatory</p><p>requirements.</p><p>· Acts as renowned expert in the cardiovascular safety field to provide expert scientific and medical input to Global</p><p>Patient Safety activities, with special focus on cross-project and cross-TA activities of a scientific nature</p><p>· Leads and endorses the development of scientific methods applied to a wide range of safety data related to drug-</p><p>induced drug/biological- induced CV toxicity</p><p>· Promotes safety sciences and clinical safety across projects and therapeutic areas</p><p>· Provides support, as needed, for discussions with internal governance and international regulatory bodies</p><p>· Contributes to improved understanding and prevention of <span>drug/biological-induced</span> CV toxicity issues across functions</p><p>within the company and across Pharmaceutical Companies and Regulatory Authorities.</p><p>· Contributes to the implementation of the Global Patient Safety strategy, and to the successful implementation of the global working model for the Clinical Safety Section. · Leads <span>drug/biological-induced</span> CV toxicity biomarker development projects and contributes to the CV preclinical strategies set-up by the preclinical CV toxicity strategy Lead.</p><p></p><p><b>Essential:</b></p><p></p><p></p><p>· Medical practitioner (medical degree) with at least 5 years drug development experience.</p><p>· Specialty training and board certification in the field of expertise</p><p>· Recognized by peers for therapeutic area expertise and commercial/safety understanding</p><p>· Regulatory Agency