
10,000+ employees
đź’Š Pharmaceuticals
🏥 Healthcare
🧬 Biotechnology
đź’° $6.5M Post-IPO Debt - Eli Lilly on 2024-02
Pharmaceuticals • Healthcare • Biotechnology
Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.
🔥 13 hours ago
🇺🇸 United States – Remote
đź’µ $153k - $268.4k / year
⏰ Full Time
đźź Senior
đź‘» Ghost score 0%
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10,000+ employees
đź’Š Pharmaceuticals
🏥 Healthcare
🧬 Biotechnology
đź’° $6.5M Post-IPO Debt - Eli Lilly on 2024-02
Pharmaceuticals • Healthcare • Biotechnology
Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.
• Serve as clinical scientist on one or more late-stage (Phase 2-3) global clinical trials for Orexin-targeted programs in sleep/wake indications • Support creation and review of clinical slides for internal and external meetings, including Investigator Meetings, SIVs, IDMCs, and Advisory Boards • Assist in authoring protocols, Clinical Study Reports, Investigator Brochures, and Development Safety Update Reports • Serve as study scientific expert from study start-up through clinical study report completion, including CRF design, enrollment monitoring, and patient profile review • Liaise with Clinical Operations on site selection, site start-up, study management, and closeout activities • Serve as point of contact for clinical inquiries from sites, CROs, site monitors, and health authorities • Perform ongoing clinical data review to monitor safety, data integrity, protocol compliance, and study performance • Partner with Clinical Operations, Regulatory Affairs, Biostatistics, and Safety/Pharmacovigilance on cross-functional program and study teams • Drive alignment and execution across functions to support timely, high-quality study delivery • Identify and address scientific, operational, and strategic risks and gaps • Develop scientific insights and recommendations to inform clinical development strategy and decision-making • Partner with biostatistics on SAP development and review and interpretation of final clinical study TLFs • Support abstracts, posters, manuscripts, and presentations for scientific meetings and publications • Provide scientific leadership in interactions with investigators, CROs, vendors, external experts, key opinion leaders, and scientific advisory boards • Ensure organization, follow-through, and proactive management of deliverables across assigned studies and workstreams • Report to the Executive Director, Clinical Development
• Advanced scientific/clinical degree (PhD or PharmD) with 2+ years drug development experience in the biotech/pharma industry, OR BS/MS in a scientific discipline with 8+ years drug development experience in the biotech/pharma industry • Strong scientific foundation in neuroscience/neurology required • Understanding of clinical trial design, clinical data analysis, and drug development principles • Demonstrated accountability for delivery on clinical studies • Proven experience in the development and authorship of clinical and regulatory documents, including protocols, IBs, CSRs, and briefing documents • Familiarity with Orexin biology or related sleep/wake and neurocircuitry mechanisms • Detail oriented with exceptional organizational skills • Effective verbal and written communication skills • Ability to identify issues, analyze situations, and provide effective solutions • Demonstrated ability to partner with cross-functional teams in a fast-paced biotech environment • Role is based in the US with occasional travel
• Company bonus depending partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
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