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Associate Director Study Leader Cell Therapy
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Are you ready to take our leading Oncology pipeline to the next level? As an Associate Director (AD) Study Leader Cell Therapy, you will be responsible for delivering a single or several smaller Cell Therapy development programs. This role requires a high degree of flexibility and autonomy, as you may also provide expert input to other non-drug programs and process improvement projects.Accountabilities:Provide expert clinical operational input into project or study level documents, and may lead the delivery of study documentsWith oversight from the Sr. Director Group Leader, Cell Therapy or the Clinical Program Director, Cell Therapy, may lead and deliver operational options for review at Investment Decision Governance interactionsLead the delivery of the clinical study(s) or program(s) from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standardsAccountable for overall study or program deliverables, maintaining oversight throughout the life of the study or programDevelop and manage effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and escalate issues to stakeholders as appropriateResponsible for planning and leading issue escalation and resolutionProvide input to forecasting and management of study/program delivery costs, resource, and timelinesAccountable for the quality of study/program planning information into relevant planning systemsMentor and support development of individuals within the organisationContribute to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaboratorsResponsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programsResponsible for study or program level reporting of progress, risks, and issuesLead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality AssuranceProvision to procurement clear specifications for study or program specific outsourcingReview and operational approval of study or program specific contracts or work ordersLead and conduct investigator meetings and other study related meetings. May convene and lead the cross-functional Study Teams for EO Cell Therapy studies.Identify areas of best practice / process improvements and knowledge share across the Cell Therapy Clinical Group.Essential Skills/Experience:University degree/Bachelor’s degree in related discipline, preferably in medical or biological science.Minimum of 5 years experience in clinical research, with at least 3 years of global study leadership or equivalentExperience with Cell Therapy and Clinical OperationExperience in driving operational delivery to timelines, cost and qualityAbility to lead strategic and/or operational management of individual clinical trialsExcellent knowledge of ICH-GCP principlesProject management experience within the context of Clinical Drug DevelopmentExperience and strength in working and leading in matrix teamsStrong collaborative communications skills including the ability to engage with diverse stakeholdersExperience in selection and oversight of external providers and development/review of contractsDesirable Skills/Experience:Higher degree e.g. PhD, MSc, MPhilProgram management qualification (e.g. MBA, PRINCE2, PMP)Experience in variety of academic/CRO/Sponsor organizations and countriesExperience of early phase clinical development deliveryExperience in autologous or allogeneic therapies in oncologyAt AstraZeneca's Oncology R&D department, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. We are a science-based, leading and decisive Oncology enterprise united in our vision to eliminate cancer as a cause of death. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next. We foster a mindset of courage, where everyone is empowered to step up, innovate and work at pace. We lead through true collaboration, building collective wisdom by giving everyone a chance to input. It's science with an impact-making a difference for patients and people around the world.Ready to make a meaningful difference? Apply today to join our teamDate Posted17-Jun-2024Closing Date30-Jun-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; US - Waltham - MAType: Full time
