AstraZeneca Pharmaceuticals LP Clinical Imaging Scientist, Immuno-Oncology in Gaithersburg, Maryland

Job Description: Clinical Imaging Scientist, Immuno-Oncology

Location: Gaithersburg, United States

Salary: We offer a competitive salary and benefits package.

This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our portfolio means we have a late stage pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines.

AstraZeneca is a leader in Immuno-Oncology (IO) therapy, with a pipeline focused on exploring the potential of IO combinations with new-mechanism immunotherapy, targeted therapy, chemotherapy, radiotherapy, etc. We believe our unique IO development program will play a critical role in continuing to redefine the cancer treatment paradigm for clinicians, patients and their families.

Main Duties and Responsibilities:

The Clinical Imaging Scientist (“CIS”) 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 Immuno-Oncology portfolio. This includes conducting research through the literature and interacting with internal key stakeholders and external key opinion leaders. The role is focused on implementation of best practice imaging and tumor assessment for key primary or secondary efficacy endpoints. The CIS will have expertise in common tumor response assessment algorithms, including RECIST 1.1, immune-related RECIST, etc., and how they are deployed.

A key responsibility of the role is supporting complex and cutting-edge clinical IO 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 CIS will interface strategically and operationally with other functional areas including medical development, clinical operations, data management, statistics, and regulatory affairs. The CIS will liaise with both the internal clinical teams and external CROs where applicable. The CIS will work closely with clinical development teams, providing training, teaching, and consistent troubleshooting. Where there is a new requirement for imaging data collection, the CIS will define with the drug project team optimal 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 Global Imaging Lead in IO Global Medicines Development.

Essential Requirements:

Experience / Qualifications / Skills:

  • 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 IO/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, negotiation and influencing skills with the ability to work interactively within multiple multidisciplinary teams.

  • Focus on timely delivery of high quality imaging results with a proactive, flexible approach.

  • Demonstrated 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.

  • Ability to work on multiple projects and under strict deadlines.

  • Strong analytical skills.

  • Experience in authoring scientific documents.

  • Creative, inquisitive, knowledgeable, and results-oriented.

Preferred Background:

  • 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 managing 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.

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.