Physician - Translational Medicine
Eli Lilly - Indianapolis, IN

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The DEM CRP, a member of the multidisciplinary Translational Medicine and Tailored Therapeutics function, 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.

Key Objectives/Deliverables:
1. Work closely with Oncology Discovery, Translational Sciences, BioTDR/AME and the Oncology 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.

Basic Requirements:
Medical Doctor or Doctor of Osteopathy.
Must be board eligible or certified in anatomic and/or clinical pathology or internal medicine and additional subspecialty training.
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

Additional Preferences:
  • Laboratory experience in a subspecialty of medicine related to Oncology.
  • Experience in cancer biology, therapeutics and/or diagnostics.
  • Clinical research or pharmaceutical medicine experience.
  • Knowledge of drug development process.
  • Fluent in English; both written and verbal communications.
  • Interpersonal, organizational and negotiation skills.
  • Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
  • Excellent teamwork skills.
  • Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.
Other Information:
  • Position located in Indianapolis, IN
  • Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.
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:

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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in...