Senior Director - Oncology and Peripheral Imaging Clinical Development
Eli Lilly and Company
8 hours ago
Remote friendly (Philadelphia, PA)
United States
Clinical Research and Development
Key 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 vs. standard-of-care imaging.
- Serve as a scientific expert in oncology imaging modalities (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, and longitudinal response assessment; evaluate imaging biomarkers for patient stratification, response, and disease monitoring.
- Evaluate imaging performance metrics (sensitivity, specificity, SUVs, tumor-to-background ratios).
- Provide strategic input into development, validation, and quantitative evaluation of advanced image analysis methods.
- Support imaging programs beyond oncology using immune-mediated, cardiovascular, and metabolic disease biology (as applicable).
- Collaborate with imaging physicians, medical oncologists, medical physicists, imaging operations, and advanced analysis teams.
- Lead cross-functional projects and coordinate with external partners (CROs, academic institutions, software developers, scanner manufacturers) for imaging method validation and implementation.
- Evaluate emerging imaging scientific/technological advances (modeling, AI) and drive their application.
- Author/review key clinical and regulatory documents (Investigator’s Brochures, protocols/amendments, clinical study reports, regulatory briefing documents).
- Contribute to technical manuals and imaging-related trial documentation.
- Communicate findings via internal presentations, conference abstracts, and peer-reviewed publications.
Qualifications:
- Medical Doctor: board eligible/certified in a relevant specialty or completed comparable post-medical-school clinical training for the hiring country.
- Non-U.S. trained physicians: education/training from an LCME-compliant medical school.
- Minimum 3 years of clinical development industry experience.
Additional Skills/Preferences:
- Tracer development experience; oncology and peripheral (non-CNS) imaging experience (highly preferred).
- Strong problem-solving skills and root-cause diagnosis.
- Familiarity with Good Clinical Practice (GCP) and regulatory requirements.
- Ability to balance scientific and business priorities.
- Demonstrated communication, collaboration, organizational, and influencing skills.
- Fluency in written and spoken English.
- Travel: ~10–15%.
Benefits (as stated):
- Eligibility to participate in company-sponsored 401(k) and pension; vacation; medical/dental/vision/prescription drug; flexible benefits (e.g., healthcare/dependent day care FSAs); life insurance/death benefits; certain time off/leave of absence; well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
- 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 vs. standard-of-care imaging.
- Serve as a scientific expert in oncology imaging modalities (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, and longitudinal response assessment; evaluate imaging biomarkers for patient stratification, response, and disease monitoring.
- Evaluate imaging performance metrics (sensitivity, specificity, SUVs, tumor-to-background ratios).
- Provide strategic input into development, validation, and quantitative evaluation of advanced image analysis methods.
- Support imaging programs beyond oncology using immune-mediated, cardiovascular, and metabolic disease biology (as applicable).
- Collaborate with imaging physicians, medical oncologists, medical physicists, imaging operations, and advanced analysis teams.
- Lead cross-functional projects and coordinate with external partners (CROs, academic institutions, software developers, scanner manufacturers) for imaging method validation and implementation.
- Evaluate emerging imaging scientific/technological advances (modeling, AI) and drive their application.
- Author/review key clinical and regulatory documents (Investigator’s Brochures, protocols/amendments, clinical study reports, regulatory briefing documents).
- Contribute to technical manuals and imaging-related trial documentation.
- Communicate findings via internal presentations, conference abstracts, and peer-reviewed publications.
Qualifications:
- Medical Doctor: board eligible/certified in a relevant specialty or completed comparable post-medical-school clinical training for the hiring country.
- Non-U.S. trained physicians: education/training from an LCME-compliant medical school.
- Minimum 3 years of clinical development industry experience.
Additional Skills/Preferences:
- Tracer development experience; oncology and peripheral (non-CNS) imaging experience (highly preferred).
- Strong problem-solving skills and root-cause diagnosis.
- Familiarity with Good Clinical Practice (GCP) and regulatory requirements.
- Ability to balance scientific and business priorities.
- Demonstrated communication, collaboration, organizational, and influencing skills.
- Fluency in written and spoken English.
- Travel: ~10–15%.
Benefits (as stated):
- Eligibility to participate in company-sponsored 401(k) and pension; vacation; medical/dental/vision/prescription drug; flexible benefits (e.g., healthcare/dependent day care FSAs); life insurance/death benefits; certain time off/leave of absence; well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).