Clinical Research Physician - Ophthalmology
Eli Lilly and Company
8 hours ago
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
Primary Responsibilities
Clinical Planning
- Understand and keep updated with pre-clinical and clinical data relevant to the product(s).
- Contribute to business unit and global alignment of clinical strategy and clinical plans.
- Collaborate with LRM leaders to develop and maintain a Draft Launch Label and Value Proposition addressing key customer needs (patient, provider, payer), including product lifecycle plan, clinical strategies, development plans, and study protocol design.
Clinical Research/Trial Execution and Support
- Plan, collaborate on, and review scientific content of clinical documents (protocols, informed consent, final study reports, and submissions such as annual reports) per project timeline.
- Provide oversight and input into integrated clinical development plans (ICDs).
- Collaborate with clinical research staff on design, conduct, and reporting of clinical trials (e.g., sample size, patient commitment, timelines, grants, governance review interactions).
- Review and approve risk profiles to ensure appropriate risk communication to study subjects.
- Participate in investigator identification and selection for clinical trials (including center of excellence identification as relevant).
- Ensure operational teams complete administrative requirements for study initiation/conduct in line with GCPs and local laws (e.g., ethical review board, informed consent, regulatory approval/notification).
- Support study start-up planning and meetings; provide training and information to investigators and site personnel.
- Serve as a resource to clinical operations/monitors, investigators, and ethical review boards; address questions and clarify issues.
- Track and monitor patient safety during studies; follow up on adverse events per corporate patient safety policies.
- Review IIT proposals and publications (as requested by Director-Clinical/Medical).
Scientific Data Dissemination/Exchange
- Comply with local laws, global policies, and procedures for data dissemination and interactions with external health care professionals.
- Address unsolicited scientific information needs of external HCPs per guidelines.
- Participate in clinical trial registry reporting.
- Support planning of symposia, advisory boards, and other HCP meetings.
- Support medical information teams with medical letters and other materials.
- Support data analysis and development/approval of slide sets and publications (abstracts, posters, manuscripts).
- Establish and maintain collaborations with external experts/thought leaders/general medical community locally, nationally, regionally, and possibly internationally.
- Steward relationships with relevant professional societies.
- Support design of stakeholder research (e.g., patients, HCPs, payers) as medical expert.
- Provide congress support (e.g., exhibits, oral/poster presentations, medical booth staffing, thought leader meetings, customer events).
- Participate in data analysis and preparation of final reports and publications.
Regulatory Support Activities
- Participate in development and review of label changes/modifications with affiliates, brand teams, regulatory, and legal.
- Provide medical expertise to regulatory scientists.
- Support preparation of regulatory reports (e.g., NDAs, FDA annual reports, Periodic Adverse Drug Experience Reports/PADERS), FDA advisory committee preparation, label discussions, local registration efforts, and resolution/communication of regulatory issues globally.
- Participate in advisory committees.
- Participate in risk management planning with affiliates and Global Patient Safety (GPS).
Business/Customer Support (Pre- and Post-Launch)
- Contribute to development and execution of medical strategies supporting brand commercialization in partnership with LRM leadership, brand teams, clinical plans personnel, and cross-functional management for global/local business plans.
- Understand and anticipate scientific information needs of development customers (payers, patients, HCPs, policymakers).
- Timely address customer questions by leading data analyses and new clinical/global patient outcomes research.
- Establish and maintain contact with external experts/opinion leaders and maintain credible scientific expertise.
- Provide clinical input to commercial organization deliverables, including PRA strategy and partnerships to demonstrate product value.
- Support ongoing strategic planning for the brand.
- Provide scientific/creative input to develop, review, and approve promotional materials and tactics.
- Understand market archetypes and potential influence on medical interventions.
- Lead definition of Patient Journey and Moments of Truth based on medical knowledge; serve as patient advocate and medical expert.
Scientific/Technical Expertise and Continued Development
- Critically read and evaluate medical literature; track competitor product status/data; stay current on relevant medical/scientific developments.
- Understand trends and projections for clinical practice and access in relevant therapeutic areas (1–2 and 3–5 years).
- Responsible for scientific training of the clinical study team.
- Act as scientific consultant and protocol expert for study team members and others.
- Seek extramural scientific experiences and attend scientific symposia.
Minimum Qualifications
- Medical Doctor (MD).
- Must be board-eligible or certified in the appropriate specialty/subspecialty, or have completed comparable post-medical school clinical training relevant to the country of hiring.
- US-trained physicians: must have achieved board eligibility or certification.
- Non-US trained physicians: may be hired in the US at the discretion of the Chief Medical Officer if they are not US board-eligible/certified.
- Non-US trained physicians: education and training at a medical school meeting LCME requirements.
- Board-eligibility or certification in ophthalmology.
Additional Preferences (Desirable)
- At least 5 years clinical research or pharmaceutical medicine experience (especially in biotechnology).
- Demonstrated knowledge of drug development process.
- Fluent English (written and verbal).
- Strong communication, interpersonal, organizational, teamwork, and negotiation skills.
- Ability to influence others cross-functionally and within the function.
- Ability to travel domestically and internationally as needed.
Benefits (explicitly stated)
- Eligible for a company bonus (full-time equivalent employees).
- Comprehensive benefits program for eligible employees, including 401(k), pension, vacation; medical/dental/vision/prescription coverage; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; time off and leave of absence; and well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
Application Instructions
- If you require an accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Clinical Planning
- Understand and keep updated with pre-clinical and clinical data relevant to the product(s).
- Contribute to business unit and global alignment of clinical strategy and clinical plans.
- Collaborate with LRM leaders to develop and maintain a Draft Launch Label and Value Proposition addressing key customer needs (patient, provider, payer), including product lifecycle plan, clinical strategies, development plans, and study protocol design.
Clinical Research/Trial Execution and Support
- Plan, collaborate on, and review scientific content of clinical documents (protocols, informed consent, final study reports, and submissions such as annual reports) per project timeline.
- Provide oversight and input into integrated clinical development plans (ICDs).
- Collaborate with clinical research staff on design, conduct, and reporting of clinical trials (e.g., sample size, patient commitment, timelines, grants, governance review interactions).
- Review and approve risk profiles to ensure appropriate risk communication to study subjects.
- Participate in investigator identification and selection for clinical trials (including center of excellence identification as relevant).
- Ensure operational teams complete administrative requirements for study initiation/conduct in line with GCPs and local laws (e.g., ethical review board, informed consent, regulatory approval/notification).
- Support study start-up planning and meetings; provide training and information to investigators and site personnel.
- Serve as a resource to clinical operations/monitors, investigators, and ethical review boards; address questions and clarify issues.
- Track and monitor patient safety during studies; follow up on adverse events per corporate patient safety policies.
- Review IIT proposals and publications (as requested by Director-Clinical/Medical).
Scientific Data Dissemination/Exchange
- Comply with local laws, global policies, and procedures for data dissemination and interactions with external health care professionals.
- Address unsolicited scientific information needs of external HCPs per guidelines.
- Participate in clinical trial registry reporting.
- Support planning of symposia, advisory boards, and other HCP meetings.
- Support medical information teams with medical letters and other materials.
- Support data analysis and development/approval of slide sets and publications (abstracts, posters, manuscripts).
- Establish and maintain collaborations with external experts/thought leaders/general medical community locally, nationally, regionally, and possibly internationally.
- Steward relationships with relevant professional societies.
- Support design of stakeholder research (e.g., patients, HCPs, payers) as medical expert.
- Provide congress support (e.g., exhibits, oral/poster presentations, medical booth staffing, thought leader meetings, customer events).
- Participate in data analysis and preparation of final reports and publications.
Regulatory Support Activities
- Participate in development and review of label changes/modifications with affiliates, brand teams, regulatory, and legal.
- Provide medical expertise to regulatory scientists.
- Support preparation of regulatory reports (e.g., NDAs, FDA annual reports, Periodic Adverse Drug Experience Reports/PADERS), FDA advisory committee preparation, label discussions, local registration efforts, and resolution/communication of regulatory issues globally.
- Participate in advisory committees.
- Participate in risk management planning with affiliates and Global Patient Safety (GPS).
Business/Customer Support (Pre- and Post-Launch)
- Contribute to development and execution of medical strategies supporting brand commercialization in partnership with LRM leadership, brand teams, clinical plans personnel, and cross-functional management for global/local business plans.
- Understand and anticipate scientific information needs of development customers (payers, patients, HCPs, policymakers).
- Timely address customer questions by leading data analyses and new clinical/global patient outcomes research.
- Establish and maintain contact with external experts/opinion leaders and maintain credible scientific expertise.
- Provide clinical input to commercial organization deliverables, including PRA strategy and partnerships to demonstrate product value.
- Support ongoing strategic planning for the brand.
- Provide scientific/creative input to develop, review, and approve promotional materials and tactics.
- Understand market archetypes and potential influence on medical interventions.
- Lead definition of Patient Journey and Moments of Truth based on medical knowledge; serve as patient advocate and medical expert.
Scientific/Technical Expertise and Continued Development
- Critically read and evaluate medical literature; track competitor product status/data; stay current on relevant medical/scientific developments.
- Understand trends and projections for clinical practice and access in relevant therapeutic areas (1–2 and 3–5 years).
- Responsible for scientific training of the clinical study team.
- Act as scientific consultant and protocol expert for study team members and others.
- Seek extramural scientific experiences and attend scientific symposia.
Minimum Qualifications
- Medical Doctor (MD).
- Must be board-eligible or certified in the appropriate specialty/subspecialty, or have completed comparable post-medical school clinical training relevant to the country of hiring.
- US-trained physicians: must have achieved board eligibility or certification.
- Non-US trained physicians: may be hired in the US at the discretion of the Chief Medical Officer if they are not US board-eligible/certified.
- Non-US trained physicians: education and training at a medical school meeting LCME requirements.
- Board-eligibility or certification in ophthalmology.
Additional Preferences (Desirable)
- At least 5 years clinical research or pharmaceutical medicine experience (especially in biotechnology).
- Demonstrated knowledge of drug development process.
- Fluent English (written and verbal).
- Strong communication, interpersonal, organizational, teamwork, and negotiation skills.
- Ability to influence others cross-functionally and within the function.
- Ability to travel domestically and internationally as needed.
Benefits (explicitly stated)
- Eligible for a company bonus (full-time equivalent employees).
- Comprehensive benefits program for eligible employees, including 401(k), pension, vacation; medical/dental/vision/prescription coverage; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; time off and leave of absence; and well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
Application Instructions
- If you require an accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation