Associate Director Study Leader, Oncology R&D, Early Oncology Clinical

The Associate Director Study Leader, Early Oncology Clinical is responsible for the delivery of clinical studies including quality, timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines. Provides matrix management of functional area representatives to cross functional clinical study teams. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility is required.

Accountabilities:

• Leads the delivery of the clinical study from concept to final CSR and through to study closure and archive to agreed budget, time, project standards, quality and scientific standards
• May convene and lead the cross functional study team(s) for Early Oncology Clinical studies based on delivery model
• Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate AZ manager or CRO representative
• Contribute to preparation and delivery of study documents (e.g. Protocols/amendments, Informed Consent Form (ICF) documents detailing study delivery data management activities, etc.)
• Responsible for forecasting and day-to-day management of study timelines, budget, materials and detailed study level plans and feasibility assessment
• Leads study recruitment and data delivery to agreed timelines and targets
• Implement agreed study level process and technology for Early Oncology clinical studies
• Manage to the agreed study timelines, budget, and resource and ensure the update of appropriate systems
• Accountable for the quality of study planning information into relevant planning systems
• Guide the study team in the development of outsourcing specifications and vendor selection
• May manage the vendor(s) throughout the life of assigned clinical trial(s) based on delivery model
• Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs
• Lead and conduct investigator meetings and other study related meetings
• Identify and communicate resource gaps for assigned studies
• Communicate study level reports and status updates for Early Oncology clinical studies
• Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
• Oversee the submission of trial-related and essential documents to the Trial Master File, maintenance and final closeout of TMF
• Ensure sponsor oversight throughout the life of the study
• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness
• Responsible for study level reporting of progress, risks and issues
• Provision to procurement clear specifications for study specific outsourcing
• Review and operational approval of study specific contracts or work orders

Essential Requirements:

• Bachelor’s degree in related discipline, preferably in medical or biological science 
• Minimum of 5 -7 years progressive experience in clinical research, with at least 3 years of global study leadership or equivalent
• Comprehensive knowledge of the clinical and pharmaceutical drug development process
• Excellent knowledge of ICH-GCP principles
• Extensive and proven experience in driving operational delivery to timelines, cost and quality
• Proven experience leading delivery through internal and external organizations
• Experience and strength in working and leading in matrix teams
• Strong collaborative communications skills including the ability to engage with a diverse client base and manage through conflict
• Proven ability in problem solving and issues management that is solution focused
• Experience in providing clear requirements for external contracts
• Experience in selection of external providers and development/review of contracts
• Proven oversight of external providers
• Experience of early phase oncology clinical delivery

At AstraZeneca, we follow the science and pioneer new frontiers. Our Oncology team is dedicated to eliminating cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025. We make bold decisions driven by patient outcomes and have built an unrivalled scientific community both internally and externally. 

Are you ready to join a team committed to improving the lives of millions with cancer? Apply now and be part of our journey to eliminate cancer as a cause of death.

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.