Imaging Clinical Research Scientist
BioSpace · Indianapolis, IN · 1 mo ago
Analyst$177k–$339k/yrFull-time
About the role
The Director/Senior Director, Imaging Clinical Research Scientist leads clinical development of diagnostic radiopharmaceutical imaging programs in oncology, immunology, and cardiovascular diseases. This role spans early and late-phase development and involves designing studies, evaluating imaging biomarkers, and collaborating with cross-functional teams.
Responsibilities
- Lead the design and execution of integrated clinical development programs for diagnostic radiopharmaceuticals in oncology, immunology, and cardiovascular diseases.
- Define clinical strategies, endpoints, patient populations, and imaging criteria for each phase of development.
- Design studies to evaluate diagnostic accuracy, optimal imaging timing, patient selection biomarkers, and comparative performance versus standard-of-care imaging.
- Evaluate and interpret molecular imaging data, including tumor localization, tracer biodistribution, dosimetry considerations, and longitudinal response assessment.
- Evaluate imaging performance metrics such as sensitivity, specificity, standardized uptake values (SUVs), and tumor to background ratios.
- Apply knowledge of oncology, immune-mediated, cardiovascular, and/or metabolic disease biology to guide the scientific strategy of diagnostic imaging programs.
- Collaborate internally with physicians, scientists, medical physicists, and with imaging operations and advanced image analysis teams.
- Lead cross-functional projects and coordinate with external partners, including CROs, academic institutions, software developers, and scanner manufacturers, to support imaging method validation and implementation.
- Evaluate emerging scientific and technological advances in imaging, including modeling approaches and artificial intelligence, and drive their application in clinical programs.
- Author and review key clinical and regulatory documents, including Investigator’s Brochures, protocols, protocol amendments, clinical study reports, and regulatory briefing documents.
- Contribute to the development of technical manuals and imaging-related trial documentation.
- Communicate scientific findings through internal presentations, conference abstracts, and peer-reviewed publications.
Requirements
- PhD in a relevant field.
- Minimum 5 years clinical development experience; minimum 3 years industry experience.
- Tracer development experience and experience in oncology, immunology, and/or cardiology is highly preferred.
- Strong problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes, and take corrective actions to prevent reoccurrence.
- Familiarity with Good Clinical Practice (GCP) and regulatory requirements.
- Strong ability to balance scientific and business priorities.
- Demonstrated communication, collaboration, and organizational skills.
- Fluency in written and spoken English.