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Associate Director Study Leader Cell Therapy

Location Gaithersburg, Maryland, United States Waltham, Massachusetts, United States Job ID R-192581 Date posted 25/06/2024

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 documents
  • With 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 interactions
  • Lead 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 standards
  • Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program
  • Develop and manage effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and escalate issues to stakeholders as appropriate
  • Responsible for planning and leading issue escalation and resolution
  • Provide input to forecasting and management of study/program delivery costs, resource, and timelines
  • Accountable for the quality of study/program planning information into relevant planning systems
  • Mentor and support development of individuals within the organisation
  • Contribute to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators
  • Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs
  • Responsible for study or program level reporting of progress, risks, and issues
  • Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
  • Provision to procurement clear specifications for study or program specific outsourcing
  • Review and operational approval of study or program specific contracts or work orders
  • Lead 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:

  • 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 equivalent
  • Clinical Operations and Cell Therapy or Gene Therapy experience
  • Experience in driving operational delivery to timelines, cost and quality
  • Ability to lead strategic and/or operational management of individual clinical trials
  • Excellent knowledge of ICH-GCP principles
  • Project management experience within the context of Clinical Drug Development
  • Experience and strength in working and leading in matrix teams
  • Strong collaborative communications skills including the ability to engage with diverse stakeholders
  • Experience in selection and oversight of external providers and development/review of contracts

Desirable Skills/Experience:

  • Higher degree e.g. PhD, MSc, MPhil
  • Program management qualification (e.g. MBA, PRINCE2, PMP)
  • Experience in variety of academic/CRO/Sponsor organizations and countries
  • Experience of early phase clinical development delivery
  • Experience in autologous or allogeneic therapies in oncology

At 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 team!

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 authorization and employment eligibility verification requirements.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.