Senior Advisor, Clinical Science

🕒 il y a 27 jours

🍂 Massachusetts – Distant

🍂 Massachusetts – Remote

💵 $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 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 • Oversee 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 and recommendations 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 • Lead interactions 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 junior clinical scientists as appropriate

🎯 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 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 in a fast-paced biotech environment • 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 • Remote role based in the US, with occasional travel

🏖️ 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 associated with the remote role

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