Senior Advisor, Clinical Science

🕒 il y a 26 jours

🇺🇸 États-Unis – Télétravail

💵 $153 000 - $283 800 / an

⏰ Temps Plein

🟠 Senior

👻 Score fantôme 13%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Eli Lilly and Company

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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 on one or more late-stage (Phase 2-3) global clinical trials for Orexin-targeted programs in sleep/wake indications • Create and/or review clinical slides for internal and external meetings, including Investigator Meetings, SIVs, IDMCs, and Advisory Boards • Author key clinical study documents, including 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; answer or triage questions • Perform ongoing clinical data review to monitor safety, data integrity, protocol compliance, and study performance • Lead cross-functional program/study teams with Clinical Operations, Regulatory Affairs, Biostatistics, and Safety/Pharmacovigilance • Drive alignment and execution across functions for high-quality, timely study delivery • Identify and address scientific, operational, and strategic risks and gaps • Develop scientific insights and recommendations for clinical development strategy and decision-making • Partner with Biostatistics on SAP development and review and interpret 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

🎯 Exigences

• 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 • Understanding of clinical trial design, clinical data analysis, and drug development principles • Demonstrated accountability for delivery on clinical studies • Proven experience in developing and authoring clinical and regulatory documents, including protocols, IBs, CSRs, and briefing documents • Familiarity with Orexin biology or related sleep/wake and neurocircuitry mechanisms • Exceptional organizational skills • Strong verbal and written communication skills • Ability to identify issues, analyze situations, and provide effective solutions • Ability to partner with cross-functional teams in a fast-paced biotech environment

🏖️ 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 • Healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Employee assistance program • Fitness benefits • Employee clubs and activities • Occasional travel

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