Senior Advisor, Clinical Science

🕒 il y a 26 jours

🇺🇸 États-Unis – Télétravail

💵 $153 000 - $283 800 / an

⏰ Temps Plein

🟠 Senior

🗣️🇺🇸🇬🇧 Anglais requis

D'où vient cette offre

Publiée sur la page carrières de Eli Lilly and Company, pas via un site d'emploi

Repérée par Remote Rocketship il y a 26 jours

Toujours ouverte sur le site de Eli Lilly and Company. Vérifiée il y a 1 heure.

Logo of Eli Lilly and Company

Eli Lilly and Company

10 000+ employés

💊 Pharmaceutique

🏥 Santé

🧬 Biotechnologie

💰 €6 500 000 Post-IPO Debt - Eli Lilly en 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company est une entreprise pharmaceutique mondiale qui recherche, développe, fabrique et distribue des médicaments sur ordonnance et propose des services de soutien aux patients. L'entreprise se concentre sur des médicaments révolutionnaires pour des maladies telles que le diabète, le cancer, la maladie d'Alzheimer, les maladies auto-immunes, la dermatologie, la migraine, l'obésité et l'apnée du sommeil ; elle mène des essais cliniques, offre des services pharmaceutiques LillyDirect et met l'accent sur la qualité de fabrication, la sécurité des médicaments et la recherche sur les médicaments génétiques. Eli Lilly propose également des ressources pour les patients, des formations sur les maladies et des programmes d'accès pour aider les personnes à trouver des soins et à participer à des essais.

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, 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 • Lead CRF design, enrollment monitoring, and patient profile review • Drive dose-escalation and study conduct discussions through review 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 development strategy • Identify and address scientific, operational, and strategic risks and gaps • Review and interpret clinical safety, efficacy, PK/PD, and exploratory biomarker data • Develop scientific insights and recommendations for clinical development decisions • Contribute to regulatory submissions, health authority responses, governance materials, and external scientific communications • Support abstracts, posters, manuscripts, and scientific meeting presentations • 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 study deliverables • Mentor and support junior clinical scientists

🎯 Exigences

• 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 • Ability to independently lead complex scientific workstreams and influence cross-functional teams • Experience leading development and authorship of clinical and regulatory documents, such as protocols, IBs, CSRs, and briefing documents • Strong analytical and scientific interpretation skills • Ability to synthesize emerging clinical, safety, and biomarker data into actionable insights • Excellent written and verbal communication skills • Ability to communicate complex scientific concepts to diverse audiences • Must be based in the United States

🏖️ Avantages

• 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 • 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

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