Director/Senior Director, Oncology and Peripheral Imaging Clinical Development
BioSpace · Philadelphia, PA · 3 wk ago
Analyst$177k–$260k/yrFull-time
About the role
The Senior Director, Imaging Clinical Research Scientist (CRS) is a key member of the medical development team, leading the clinical development of oncology and peripheral imaging. This role spans both diagnostic and therapeutic applications and contributes across the full clinical development lifecycle, from early phase studies through registrational trials for oncology, immunology, and cardiometabolic disease.
Responsibilities
- Lead the design and execution of integrated clinical development programs for oncology and peripheral imaging across early and late-phase development.
- 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.
- Serve as a scientific expert in oncology imaging modalities, including PET, SPECT, CT, MRI, and emerging theranostic platforms.
- Analyze and interpret molecular imaging data (e.g., PET/CT, SPECT/CT), including tumor localization, tracer biodistribution, dosimetry considerations, and longitudinal response assessment. Evaluate and interpret imaging biomarkers for patient stratification, response assessment, and disease monitoring across solid tumors and hematologic malignancies.
- Evaluate imaging performance metrics such as sensitivity, specificity, standardized uptake values (SUVs), and tumor to background ratios.
- Provide strategic input into the development, validation, and quantitative evaluation of advanced image analysis methods.
- Apply knowledge of immune-mediated, cardiovascular, and metabolic disease biology to support imaging programs beyond oncology, as applicable.
- Collaborate internally with imaging physicians, medical oncologists, medical physicists, as well as with imaging operations and advanced 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
- Advanced scientific degree (PhD).
- Minimum 3 years clinical development experience (Industry experience will be considered).
Qualifications
- 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, organizational, and influencing skills.
- Fluency in written and spoken English.
- Travel estimated at 10-15%.