Senior Advisor, Clinical Science

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $168k - $283.8k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $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.

📋 Description

• Serve as clinical scientist lead on one or more early-stage Phase 1/2 clinical trials for Orexin-targeted programs • Contribute to clinical development plan strategy, including study design, dose-escalation/titration strategy, and data interpretation • Lead development, authorship, and review of clinical and cross-functional documents, including protocols, amendments, investigator brochures, eCRFs, completion guidelines, SAP/TLF shells, and regulatory briefing materials • Serve as study medical/scientific lead from study start-up through clinical study report completion • Drive dose-escalation and study conduct discussions through review and interpretation of emerging safety, PK/PD, and biomarker data • Provide scientific leadership in data review meetings, safety review committees, governance forums, and cross-functional discussions • Partner with Clinical Operations, Translational Science, Regulatory Affairs, Biostatistics, and Safety/Pharmacovigilance • Drive cross-functional alignment and execution for timely, high-quality study delivery • Integrate biomarker and mechanistic hypotheses into clinical studies and broader development strategy • Identify and address scientific, operational, and strategic risks and gaps • Review and interpret clinical data, including safety, efficacy, PK/PD, and exploratory biomarkers • Develop scientific insights and recommendations for clinical development strategy and decision-making • Contribute to regulatory submissions, health authority responses, governance materials, and external scientific communications • Support abstracts, posters, manuscripts, and presentations for scientific meetings and publications • Provide scientific leadership with investigators, CROs, vendors, external experts, key opinion leaders, and scientific advisory boards • Lead or support investigator meetings and scientific training sessions • Ensure organization, follow-through, and proactive management of deliverables • Mentor and support junior clinical scientists, scope dependent on level

🎯 Requirements

• Advanced scientific/clinical degree (PhD or PharmD strongly preferred) • 8–10 years of experience in clinical research or clinical development within the biotechnology or pharmaceutical industry • Strong scientific foundation in neuroscience/neurology required • Experience in neurodegeneration and/or neuropsychiatric indications strongly preferred • Familiarity with Orexin biology or related sleep/wake and neurocircuitry mechanisms is a plus • Deep understanding of clinical trial design, clinical data analysis, and drug development principles • Direct experience leading or supporting early-phase (Phase 1/2) clinical trials • Demonstrated ability to independently lead complex scientific workstreams and influence cross-functional teams • Proven experience leading the development and authorship of clinical and regulatory documents, such as protocols, IBs, CSRs, and briefing documents • Strong analytical and scientific interpretation skills • Excellent written and verbal communication skills • Ability to work remotely from the United States • Occasional travel

🏖️ Benefits

• Company bonus depending in part 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 • Certain time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Remote work arrangement • Occasional travel