Senior Advisor, Clinical Science

🕒 il y a 27 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 multinationale qui recherche, développe, fabrique et commercialise des médicaments sur ordonnance dans plusieurs domaines thérapeutiques, y compris le diabète, l'oncologie, l'immunologie, les neurosciences et la douleur. Basée à Indianapolis, dans l'Indiana, Lilly est reconnue pour sa vaste R&D, le développement clinique et la commercialisation mondiale de médicaments biologiques et de petites molécules. L'entreprise se concentre sur la découverte de médicaments, les essais cliniques, les approbations réglementaires et la fabrication et distribution pharmaceutique à grande échelle.

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 • Support creation and review of clinical slides for internal and external meetings, including Investigator Meetings, SIVs, IDMCs, and Advisory Boards • Assist in authoring 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 primary contact for clinical inquiries from sites, CROs, site monitors, and health authorities; answer or triage questions and integrate clinical/regulatory strategy into global product development strategy • Perform ongoing clinical data review to monitor safety, data integrity, protocol compliance, and study performance • Serve as a core scientific leader on cross-functional program and study teams • Drive alignment and execution across functions to support high-quality, timely 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 preparation of abstracts, posters, manuscripts, and presentations for scientific meetings and publications • Provide scientific leadership in interactions with investigators, CROs, vendors, and external experts • Represent clinical science in interactions with key opinion leaders and scientific advisory boards in sleep/wake disorders • Manage deliverables across assigned studies and workstreams

🎯 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 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

🏖️ 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 • Occasional travel

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