The Clinical Research Physician (CRP) role in Diagnostic and Experimental Medicine (DEM) is a key role in the Translational Medicine and Tailored Therapeutics area. The DEM CRP provides clinical and laboratory medicine expertise enabling the development of novel and routine biomarkers used to support clinical drug development. This involves providing laboratory-based subspecialty biomarker consultation across all phases of the development process; oversight of novel clinical biomarker discovery, validation and application; and the development and implementation of therapeutic area and molecule-specific biomarker strategies. In addition, the DEM CRP ensures that the pharmacogenomics strategy is fully integrated with the biomarker strategy for each asset.
1. Work closely with Discovery, Translational Science, BioTDR/AME and the Lilly Business Unit to ensure that all drug candidates moving to candidate selection have comprehensive biomarker and pharmacogenomic strategies in place; specifically strategies related to patient stratification¸ pharmacodynamic effects (such as target engagement/effect on target pathway) and safety. Adapt the strategy as new data emerges during drug development.
2. Direct the development and validation of novel biomarkers in collaboration with the Laboratory for Experimental Medicine, external academic collaborators and commercial partners.
3. Assist in the development of protocols (Phase I through Phase IV) for all assigned assets ensuring that protocol design supports the molecule-specific biomarker strategy.
4. Ensure that appropriate, technically sound biomarker assays are in place to support clinical studies. Work with Clinical Diagnostic Services to monitor performance of assays during execution of clinical studies.
5. Assist in statistical analysis plan development and execution for biomarker analysis and provide pertinent clinical/technical guidance.
6. Review and interpret interim and final laboratory/biomarker data, as required; address biomarker-related analytical and clinical validation, safety and patient management issues. Assist in writing and editing summaries of data analyses and related publications. Participate in internal and external presentation of clinical biomarker results.
7. Support external scientific and regulatory initiatives seeking to advance use of biomarkers in the development and approval of new chemical entities and biologics.
- Medical Doctor or Doctor of Osteopathy.
- Must be board eligible or certified in anatomic and/or clinical pathology or internal medicine with additional subspecialty training or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
- 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). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
- Laboratory experience in a subspecialty of medicine related to diabetes, cardiology, or nephrology.
- Experience and deep knowledge in related disease pathogenesis, therapeutics and/or diagnostics.
- Experience in novel clinical assay/biomarker development.
- Clinical research or pharmaceutical medicine experience.
- Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
- Excellent teamwork skills.
- Must demonstrate excellent analytical and problem solving skills.
- Detail oriented.
- Ability to prioritize effectively.
- Flexibility and adaptability needed to enhance success in the Lilly culture.
- Fluent in English; both written and verbal communications.
Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. A company rich in heritage, Lilly employs individuals, conducts research and markets products worldwide. By providing for the unmet needs of our customers through a continuous stream of innovation, we will outgrow all competitors. Lilly earns consistent and wide recognition for creating an exceptional work environment while maintaining our highly regarded reputation in the Pharmaceutical Industry and Community. The following is a selection of awards and recognition Lilly has received in recent years:
- Position located in Indianapolis, IN
- Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.
Awards and Recognition
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