Executive Director, Multiprogram Patient Safety Oncology

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.Patient Safety at AstraZeneca is now looking for Heads of MultiprogramPharmacovigilance (PV) Oncology to join our teams.The core purpose of AstraZeneca Patient Safety is to add value to AstraZeneca products, provide clear science based guidance for investigators and prescribers to safeguard patients as well as the success of our business. Patient Safety covers the entire clinical life cycle of a drug from first time into man to withdrawal of a product from the market.Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our offices are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.What you’ll do The PV Head is a global role providing strategic PS input for TA and/or Disease Areas and quality and compliance oversight to a family of drug development and post-marketing programs across life-cycle of substances and products. This includes dTPPs, patient populations, scientific understanding of toxicity-related mechanisms, risk management commitments, risk mitigation and communication.The PV Head recruits and manages a global team of safety physicians and scientists, or recruit and manage a global team of group leaders and scientists and physicians,  in order to support major PS programs and key initiatives.Your main accountabilities / responsibilities: In the role as the Head of Multiprogram PV Oncology, you will:Recruit and manage team of safety physicians and scientists supporting major programs, or recruit and manage team of group physician and scientist leaders.Drive staff development in support of AstraZeneca productsContribute to ensure that an adequate number of qualified physicians and staff is available for Patient Safety to satisfy AstraZeneca’s objectives in the Patient Safety areaEnsure that own work and work of team is compliant with Good  Clinical and Pharmacovigilance Practice, Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.Use expertise and knowledge of global issues to develop strategic Physicians and Scientists objectives for inclusion into business objectivesProvide TA Disease Area strategic PS input to a family of drug development and post-marketing programs across life-cycle of substances and products – e.g to dTPPs, patient populations, scientific  understanding of toxicity-related mechanisms, ensure risk management commitments, risk mitigation and communication.Be accountable at Portfolio-level for quality incl review of key deliverables (eg RMPs and PSRs),  and adherence to PV regulations.Define strategies or leads AstraZeneca’s response to complex technical issues for specific safety aspects in relation to current projects, new projects and various plansRepresent content matter expertise at high level decision-making bodies such as LSPC, SARB, ESB and Development Review Committee on behalf of the relevant PSTAVPBe responsible for SIRC Chair role and Chairperson consultation for assigned productsChair Patient Safety peer reviewWork across a number of disease areas in the TA and oversee Safety Physicians, Scientists and SSaMTs working in a portfolio of AstraZeneca assets in the TARepresent AstraZeneca Patient Safety in external regulatory meetingsInfluence AstraZeneca TA strategiesInfluence the Patient Safety interface with all Clinical Development groups and Regulatory Affairs leads in the TA and with the Commercial organisationReview regulatory communication and preparation of higher level documents (eg RMPs, PBRER, DSUR)Closely follow medical developments within assigned areas and disseminates new information within Patient Safety to transform trends and emerging data into new plansFollow important developments and trends in scientific literature and develops contacts with opinion leadersShare best practice in Patient Safety TAParticipate in the respective PSTA leadership teamEssential for the roleMinimum PhD.Medical/clinical/scientific qualification and postgraduate training, or equivalent standards12 Years of relevant Pharma experience.Experience in providing strategic leadership to complex drug projectsRelevant industry experience in Pharmacovigilance fieldExperience in managing a scientific teamDemonstrated ability to influence key stakeholders within and outside of companyDemonstrated proficiency with both written and verbal communicationsDesirable for the roleMD and or extensive experience in a scientific disciplineExtensive general medical knowledgeAble to work across TAs and FunctionsResearch background including peer reviewed publicationsDate Posted02-Sept-2024Closing Date29-Nov-2024Our 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; Spain - Barcelona; UK - Luton; US - Waltham - MAType: Full time