Clinical Research Physician - Development, Neuroscience
Eli Lilly and Company
6 hours ago
Remote friendly (Indianapolis, IN)
United States
$198,000 - $356,400 USD yearly
Clinical Research and Development
Development Clinical Research Physician (CRP)
Responsibilities:
- Monitor ongoing corporate/global clinical trials; ensure patient safety; track and follow adverse events.
- Collaborate to develop/maintain draft launch label & value proposition, product lifecycle plan, clinical strategies, development plans, and protocol design.
- Plan, review, and oversee clinical documents (protocols, informed consents, final reports, submissions); provide input into ICDs.
- Support local trial design/conduct/reporting (e.g., sample size, timelines, grants, governance interactions) and approve risk profiles.
- Ensure study start-up administrative requirements are completed (IRB/ethics review, informed consent, regulatory approval/notification) in line with GCP and local laws.
- Disseminate clinical data (registries, publications, slide sets), plan meetings/symposia, and provide scientific input to investigators, healthcare professionals, and customers.
- Provide regulatory support (label changes/modifications, NDA/FDA reporting, PADERS, advisory committees, risk management planning).
- Support brand commercialization and customer needs (payer/patient/provider), promotional materials review, and patient journey definition.
Minimum Qualifications:
- Psychiatrist: MD or DO; board eligible/certified in psychiatry (or equivalent post-medical clinical training per country of hiring).
- Non-US trained physicians: medical education/training at an LCME-compliant medical school.
Preferred Qualifications/Skills:
- Psychiatry clinical research strongly preferred.
- 3+ years industry clinical development (incl. medical monitoring and/or regulatory submissions) or 5 years academic clinical research.
- Knowledge of drug development; fluent English; strong communication/interpersonal/organizational/teamwork/negotiation; ability to influence cross-functionally; domestic/international travel.
Benefits (as stated): 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
Location: Indianapolis, US; remote/hybrid may be considered with periodic travel to headquarters.
Responsibilities:
- Monitor ongoing corporate/global clinical trials; ensure patient safety; track and follow adverse events.
- Collaborate to develop/maintain draft launch label & value proposition, product lifecycle plan, clinical strategies, development plans, and protocol design.
- Plan, review, and oversee clinical documents (protocols, informed consents, final reports, submissions); provide input into ICDs.
- Support local trial design/conduct/reporting (e.g., sample size, timelines, grants, governance interactions) and approve risk profiles.
- Ensure study start-up administrative requirements are completed (IRB/ethics review, informed consent, regulatory approval/notification) in line with GCP and local laws.
- Disseminate clinical data (registries, publications, slide sets), plan meetings/symposia, and provide scientific input to investigators, healthcare professionals, and customers.
- Provide regulatory support (label changes/modifications, NDA/FDA reporting, PADERS, advisory committees, risk management planning).
- Support brand commercialization and customer needs (payer/patient/provider), promotional materials review, and patient journey definition.
Minimum Qualifications:
- Psychiatrist: MD or DO; board eligible/certified in psychiatry (or equivalent post-medical clinical training per country of hiring).
- Non-US trained physicians: medical education/training at an LCME-compliant medical school.
Preferred Qualifications/Skills:
- Psychiatry clinical research strongly preferred.
- 3+ years industry clinical development (incl. medical monitoring and/or regulatory submissions) or 5 years academic clinical research.
- Knowledge of drug development; fluent English; strong communication/interpersonal/organizational/teamwork/negotiation; ability to influence cross-functionally; domestic/international travel.
Benefits (as stated): 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
Location: Indianapolis, US; remote/hybrid may be considered with periodic travel to headquarters.