Clinical Imaging Medical Director- Oncology

The Clinical Imaging Medical Director will provide strategic and technical expertise on the conception and implementation of imaging strategies in all phases of clinical development (Phase I-III) within the Oncology portfolio. The role is focused on implementation of standard methodology imaging and tumor assessment for key primary, secondary and exploratory efficacy endpoints. This role will have expertise in common tumor response assessment algorithms, including RECIST 1.1, immune-related RECIST, RANO, etc., and how they are deployed in a clinical trial.

A key responsibility of the role is supporting sophisticated and cutting-edge clinical targeted drug development programs by improving imaging and tumor assessment processes within clinical research or developing and introducing new technologies and approaches at the national, regional or global level, consistent with AstraZeneca and Regulatory standards.
The role will interface strategically and operationally with other functional areas including medical development, clinical operations, data management, statistics, and regulatory affairs. This individual will liaise with both the internal clinical teams and external CROs where applicable. The role will work closely with clinical development teams, providing training, teaching, and consistent troubleshooting. Where there is a new requirement for imaging data collection, the the role will define with the drug project team efficient tumor assessment data collection methods and will support the AstraZeneca team with internal standard development and consistent implementation by clinical and imaging CROs for independent central review across the suite of studies requiring the assessment.
This is a vertical role with technical imaging support provided to all levels of the drug project team from the study delivery associate level through to the clinical science director, reporting to the AZ Head of Clinical Imaging.

Essential for the role

• M.D degree or international equivalent.
• 5 years of relevant experience required
• Imaging related degree and/or professional training preferably with practical clinical experience related to immuno-oncology/oncology imaging, either radiographic, medical or physical science based.
• Extensive experience in supporting Oncology clinical trials across phases I-III with the delivery of imaging components will be considered as an alternative to formal qualifications in this field.
• Good communication and influencing skills with the ability to work interactively within multidisciplinary teams.
• Focus on timely delivery of high-quality imaging results with a proactive, flexible approach.
• Understanding of the Blinded Independent Centralized Review process at external imaging CROs, including common review paradigms, radiologist reviewer analysis application and eCRFs, and operational and regulatory documents including Independent Review Imaging Charters.

Desirable for the role

• Experience in the use of Medical Imaging in IO/Oncology research, especially in clinical trials.
• Understanding of the end-to-end drug development process.
• Sufficient Immunology and Oncology disease area knowledge to be able to interact with confidence with internal and external IO partners.
• Technical experience and training on common clinical imaging modalities, including CT, MRI, PET/CT, bone scans, etc.
• Evidence of strong leadership of leading the imaging interface with the external community; e.g., CRO or third-party provider, site monitors, study team etc. with a focus on timely delivery of quality data is preferred.
• Experience providing advice on quality assurance and data integrity to uphold GCP and regulatory compliance at Investigative sites and external vendors, as well as troubleshooting issues
• Experience functioning as the Imaging subject matter expert working with clinical development teams (evidence of leading cross functional teams focusing on good communication, passion for customers and working collaboratively).
• Experience working with PACS systems and image analysis software and having a basic understanding of the emerging integration of AI and machine learning in imaging.