Executive Director Early Development Clinical Research Physician - Neuroscience
Eli Lilly and Company
10 hours ago
Remote friendly (Indiana, United States)
United States
Clinical Research and Development
Purpose and Role
- Serve as Clinical Research Physician (CRP) clinical lead to progress early clinical assets into first-in-human studies and support further development through clinical pharmacology and mechanistic studies.
- Participate in development, conduct, and reporting of global clinical trials; implementation of global clinical trials; reporting adverse events as required.
- Review protocols, study reports, publications, data dissemination, labels, grant submissions, contracts, and regulatory communications; support external clinical customer outreach.
Basic Qualifications
- M.D. or D.O. (non-U.S. trained physicians must meet LCME requirements).
- Board eligible or certified in appropriate specialty/subspecialty, or completed comparable post-medical school clinical training relevant to hiring country.
- U.S.-trained physicians: board eligible or certified.
- Foreign medical graduates (if not U.S. board eligible/certified) may be hired at discretion of the Chief Medical Officer.
- At least 5 years of pharmaceutical industry, research, or clinical experience relevant to Phase 1/Phase 2 clinical trial design and conduct.
Additional Skills/Preferences
- Pharmaceutical company experience.
- Neuroscience/neurodegeneration/pain research experience.
- Clinical Pharmacology experience.
- Genetic therapy modality experience (e.g., siRNA, ASO, gene therapy).
- Additional scientific training/degree (M.S., Ph.D.).
- Fluent English (written and verbal).
- Strong communication, interpersonal, organizational, teamwork, negotiation skills; ability to influence in matrix environments.
- Ability to travel domestically/internationally (~10–15%).
Core Job Responsibilities
- Clinical planning: develop clinical strategy/plan; support first-in-human biomarker plans; plan Phase 2/3 and submission plans; collaborate with safety, PK/PD, ADME, Statistics, Tailored Therapeutics; integrate models; support Exploratory Medicine/Pharmacology Phase 1/2 and submission planning; partner with discovery and Brand/Business Unit colleagues.
- Clinical research/trial execution: design/oversee clinical pharmacology studies (SAD/MAD, PK/BA/BE, DDI, food effect, renal/hepatic impairment, mechanistic); biomarker qualification; protocol development; GCP/local requirements documentation; develop protocols/data requirements with internal/external partners; investigator selection; risk profile and informed consent input; study initiation oversight; investigator/site training; resource for monitors/ETBs/investigators; safety monitoring and adverse event tracking; pharmacovigilance; oversight with third-party organizations.
- Scientific data dissemination/exchange: comply with data dissemination and interactions guidelines; address unsolicited HCP questions; clinical trial registry reporting; publication strategy; present/publish results; pharmacoepidemiology/health economics considerations; support meetings with HCPs; final reports/publications; regulatory clinical reports.
- Regulatory support: support preparation of regulatory reports (IND medical sections, Investigator Brochure, FDA advisory committee/label discussions) and resolution of regulatory issues.
- People management/development: develop and retain workforce; foster inclusion/innovation/continual improvement; develop talent base for judgment-based risk-taking.
- Business customer support (pre/post launch): develop medical strategies for commercialization; understand information needs of business/payers/patients/HCPs; maintain expert/opinion leader relationships; support B2B/B2G as medical expert; support brand strategic planning; understand market archetypes and influence on medical interventions.
Benefits (as stated)
- Company bonus (for full-time equivalent employees, depending on company/individual performance).
- 401(k), pension; vacation.
- Medical, dental, vision, prescription drug benefits.
- Flexible benefits (e.g., healthcare and/or dependent day care FSA).
- Life insurance and death benefits; time off/leave benefits.
- Well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
- Serve as Clinical Research Physician (CRP) clinical lead to progress early clinical assets into first-in-human studies and support further development through clinical pharmacology and mechanistic studies.
- Participate in development, conduct, and reporting of global clinical trials; implementation of global clinical trials; reporting adverse events as required.
- Review protocols, study reports, publications, data dissemination, labels, grant submissions, contracts, and regulatory communications; support external clinical customer outreach.
Basic Qualifications
- M.D. or D.O. (non-U.S. trained physicians must meet LCME requirements).
- Board eligible or certified in appropriate specialty/subspecialty, or completed comparable post-medical school clinical training relevant to hiring country.
- U.S.-trained physicians: board eligible or certified.
- Foreign medical graduates (if not U.S. board eligible/certified) may be hired at discretion of the Chief Medical Officer.
- At least 5 years of pharmaceutical industry, research, or clinical experience relevant to Phase 1/Phase 2 clinical trial design and conduct.
Additional Skills/Preferences
- Pharmaceutical company experience.
- Neuroscience/neurodegeneration/pain research experience.
- Clinical Pharmacology experience.
- Genetic therapy modality experience (e.g., siRNA, ASO, gene therapy).
- Additional scientific training/degree (M.S., Ph.D.).
- Fluent English (written and verbal).
- Strong communication, interpersonal, organizational, teamwork, negotiation skills; ability to influence in matrix environments.
- Ability to travel domestically/internationally (~10–15%).
Core Job Responsibilities
- Clinical planning: develop clinical strategy/plan; support first-in-human biomarker plans; plan Phase 2/3 and submission plans; collaborate with safety, PK/PD, ADME, Statistics, Tailored Therapeutics; integrate models; support Exploratory Medicine/Pharmacology Phase 1/2 and submission planning; partner with discovery and Brand/Business Unit colleagues.
- Clinical research/trial execution: design/oversee clinical pharmacology studies (SAD/MAD, PK/BA/BE, DDI, food effect, renal/hepatic impairment, mechanistic); biomarker qualification; protocol development; GCP/local requirements documentation; develop protocols/data requirements with internal/external partners; investigator selection; risk profile and informed consent input; study initiation oversight; investigator/site training; resource for monitors/ETBs/investigators; safety monitoring and adverse event tracking; pharmacovigilance; oversight with third-party organizations.
- Scientific data dissemination/exchange: comply with data dissemination and interactions guidelines; address unsolicited HCP questions; clinical trial registry reporting; publication strategy; present/publish results; pharmacoepidemiology/health economics considerations; support meetings with HCPs; final reports/publications; regulatory clinical reports.
- Regulatory support: support preparation of regulatory reports (IND medical sections, Investigator Brochure, FDA advisory committee/label discussions) and resolution of regulatory issues.
- People management/development: develop and retain workforce; foster inclusion/innovation/continual improvement; develop talent base for judgment-based risk-taking.
- Business customer support (pre/post launch): develop medical strategies for commercialization; understand information needs of business/payers/patients/HCPs; maintain expert/opinion leader relationships; support B2B/B2G as medical expert; support brand strategic planning; understand market archetypes and influence on medical interventions.
Benefits (as stated)
- Company bonus (for full-time equivalent employees, depending on company/individual performance).
- 401(k), pension; vacation.
- Medical, dental, vision, prescription drug benefits.
- Flexible benefits (e.g., healthcare and/or dependent day care FSA).
- Life insurance and death benefits; time off/leave benefits.
- Well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).