This role will occupy a key position within the medical team to support development, pre-launch and launch activities for PET diagnostics and other imaging and biomarkers as well as coordinate and partner cross functionally with imaging, neuroscience, and oncology and clinical teams to ensure optimum integration of novel imaging and biomarker methods.

Purpose:

Through the application of scientific/medical training, clinical expertise, and relevant clinical experience, the Development Clinical Research Physician (CRP) participates in: the development, conduct and reporting of clinical trials in support of clinical trial use, registration and commercialization of diagnostic products; the review process for protocols, study reports, and publications and data dissemination for products, outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product. The Clinical Research Physician serves as a scientific resource for study teams, departments, and others as needed.

The CRP must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.

Responsibilities:

The primary responsibilities of the Development CRP are generally related to compounds that are in development and include the following:

• Collaborate with clinical research staff in the design, conduct and reporting of clinical trials
• Analyze and summarize the clinical findings from studies to support decisions regarding safety and efficacy as well as regulatory strategy, results summarization and publications
• Provide expert interpretation of scans obtained in clinical trials
• Collaborate with Imaging Research and Development by providing imaging analysis expertise and making appropriate recommendations
• Contribute to business unit and global alignment of clinical strategy and clinical plans
• Understand and keep updated with relevant pre-clinical and clinical data
• Anticipate the evolution of imaging and imaging applications and seek ways to position Lilly to best evaluate the potential value of these directions
• Assist in developing, reviewing, and approving Phase 1-3 and post-market clinical imaging studies
• Interface with scientific and educational organizations involved in clinical imaging
• Support review of data analysis and the development of slide decks and publications (abstracts, posters, manuscripts)
• Seek out opportunities to stay abreast of new developments in diagnostic imaging technology
• Serve as resource to clinical operations personnel/ clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study
• Understand and actively address the scientific information needs of all investigators and personnel
• Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures
• Other duties as assigned

Minimum Qualification Requirements:

• Advanced degree required (MD/DO) with 3+ years’ experience post training in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification
• Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME).

Additional Preferences:

• Medical residency/fellowship in Radiology, nuclear medicine or oncology preferred
• Demonstrated knowledge of drug development process
• Fluent in English; strong written and verbal communications
• Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills
• Demonstrated ability to influence others (both cross-functionally and within the function) to create a positive working environment
• Domestic and international travel estimated at 30%