Senior Director - Oncology and Peripheral Imaging Clinical Development
Eli Lilly and Company
9 hours ago
Remote friendly (Indiana, United States)
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, 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, and longitudinal response assessment; evaluate imaging biomarkers for stratification, response, and monitoring across solid tumors and hematologic malignancies.
- Evaluate imaging performance metrics (sensitivity, specificity, standardized uptake values/SUVs, tumor-to-background ratios).
- Provide strategic input into 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.
- 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/implementation.
- Evaluate emerging imaging scientific/technological advances (modeling, AI) and drive adoption in clinical programs.
- Author and review key clinical/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.
Basic Requirements:
- Medical Doctor board eligible/certified in a relevant specialty (or completed comparable post-medical school clinical training for the hiring country). U.S. physicians must have achieved board eligibility or certification.
- Non-U.S. trained physicians: education/training at 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%.
Compensation/Benefits:
- Anticipated wage: $198,000–$356,400.
- Eligibility for company bonus (dependent on company/individual performance).
- Company-sponsored 401(k), pension, vacation benefits, medical/dental/vision/prescription benefits, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- 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, 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, and longitudinal response assessment; evaluate imaging biomarkers for stratification, response, and monitoring across solid tumors and hematologic malignancies.
- Evaluate imaging performance metrics (sensitivity, specificity, standardized uptake values/SUVs, tumor-to-background ratios).
- Provide strategic input into 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.
- 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/implementation.
- Evaluate emerging imaging scientific/technological advances (modeling, AI) and drive adoption in clinical programs.
- Author and review key clinical/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.
Basic Requirements:
- Medical Doctor board eligible/certified in a relevant specialty (or completed comparable post-medical school clinical training for the hiring country). U.S. physicians must have achieved board eligibility or certification.
- Non-U.S. trained physicians: education/training at 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%.
Compensation/Benefits:
- Anticipated wage: $198,000–$356,400.
- Eligibility for company bonus (dependent on company/individual performance).
- Company-sponsored 401(k), pension, vacation benefits, medical/dental/vision/prescription benefits, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation