Infectious Disease Clinical Research Physician
Eli Lilly and Company
18 days ago
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
Responsibilities:
- Design and develop clinical trial protocols, statistical analysis plans, and other essential study documents for infectious disease programs.
- Serve as a medical expert for assigned clinical trials, providing medical input and oversight throughout the study lifecycle (site selection, investigator meetings, data review).
- Monitor and interpret clinical trial data; identify safety signals, efficacy trends, and potential issues; propose appropriate actions.
- Lead and participate in interactions with regulatory authorities (e.g., FDA, EMA) regarding clinical trial design, data submission, and labeling.
- Collaborate with cross-functional teams (preclinical research, biostatistics, regulatory affairs, clinical operations, commercial); supervise teams as assigned.
- Contribute to preparation of clinical study reports, publications, and conference presentations.
- Provide medical expertise to internal project teams and external investigators.
- Stay abreast of scientific/clinical developments in infectious diseases and clinical research methodology.
- Ensure compliance with applicable regulations, Good Clinical Practice (GCP), and company SOPs.
Basic Qualifications:
- M.D. or D.O. (non-U.S. trained must meet LCME education/training requirements).
- Board eligible/certified in relevant specialty/subspecialty (or equivalent post-medical clinical training).
- U.S. trained physicians must have achieved board eligibility/certification (foreign grads may be hired at Chief Medical Officer discretion).
- Minimum 5 years’ clinical research experience in pharmaceutical industry or academic research.
Additional Preferences:
- Pediatric or adult infectious disease board eligibility/certification (highly desirable).
- Significant infectious disease focus in industry/academia.
- Experience designing, conducting, and interpreting Phase 1/2/3 trials.
- Knowledge of drug development, regulatory requirements, and GCP.
- Strong communication and presentation skills; ability to work in a fast-paced matrix environment.
- Ability to analyze/interpret complex scientific and clinical data.
- Global clinical trial experience (highly desirable).
- Peer-reviewed publications (plus).
Benefits:
- Company bonus (full-time equivalent; based on company/individual performance).
- Eligible benefits include 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave of absence, and well-being benefits.
Application:
- If you need accommodation to submit a resume, complete: https://careers.lilly.com/us/en/workplace-accommodation
- Design and develop clinical trial protocols, statistical analysis plans, and other essential study documents for infectious disease programs.
- Serve as a medical expert for assigned clinical trials, providing medical input and oversight throughout the study lifecycle (site selection, investigator meetings, data review).
- Monitor and interpret clinical trial data; identify safety signals, efficacy trends, and potential issues; propose appropriate actions.
- Lead and participate in interactions with regulatory authorities (e.g., FDA, EMA) regarding clinical trial design, data submission, and labeling.
- Collaborate with cross-functional teams (preclinical research, biostatistics, regulatory affairs, clinical operations, commercial); supervise teams as assigned.
- Contribute to preparation of clinical study reports, publications, and conference presentations.
- Provide medical expertise to internal project teams and external investigators.
- Stay abreast of scientific/clinical developments in infectious diseases and clinical research methodology.
- Ensure compliance with applicable regulations, Good Clinical Practice (GCP), and company SOPs.
Basic Qualifications:
- M.D. or D.O. (non-U.S. trained must meet LCME education/training requirements).
- Board eligible/certified in relevant specialty/subspecialty (or equivalent post-medical clinical training).
- U.S. trained physicians must have achieved board eligibility/certification (foreign grads may be hired at Chief Medical Officer discretion).
- Minimum 5 years’ clinical research experience in pharmaceutical industry or academic research.
Additional Preferences:
- Pediatric or adult infectious disease board eligibility/certification (highly desirable).
- Significant infectious disease focus in industry/academia.
- Experience designing, conducting, and interpreting Phase 1/2/3 trials.
- Knowledge of drug development, regulatory requirements, and GCP.
- Strong communication and presentation skills; ability to work in a fast-paced matrix environment.
- Ability to analyze/interpret complex scientific and clinical data.
- Global clinical trial experience (highly desirable).
- Peer-reviewed publications (plus).
Benefits:
- Company bonus (full-time equivalent; based on company/individual performance).
- Eligible benefits include 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave of absence, and well-being benefits.
Application:
- If you need accommodation to submit a resume, complete: https://careers.lilly.com/us/en/workplace-accommodation