Senior Advisor, Clinical Pharmacology

🕒 il y a 18 jours

🍂 Massachusetts – Distant

🍂 Massachusetts – Remote

💵 $168 000 - $268 400 / an

⏰ Temps Plein

🟠 Senior

👻 Score fantôme 10%

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

• Provide clinical pharmacology and PK/PD input to project teams, contributing to decisions on dose, patient population, and study design • Conduct and interpret noncompartmental and population PK analyses, including structural model development, covariate evaluation, and model diagnostics, for Phase 1–2 studies • Build and apply exposure–response and PK/PD analyses and PBPK models to support dose selection and drug–drug interaction risk assessment • Integrate nonclinical PK/PD, in vitro ADME, and biomarker data to support human PK and dose projections, interspecies scaling, and first-in-human rationale • Draft PK/PD sections of clinical development plans, protocols, analysis plans, investigator brochures, study reports, and regulatory documents including IND, CTA, and NDA/MAA submissions • Collaborate with experts across DMPK, translational sciences, clinical development, bioanalysis, biostatistics, regulatory affairs, and project leadership • Provide day-to-day scientific oversight of CRO and vendor deliverables • Participate in peer review of analyses and reports • Present findings to internal stakeholders • Contribute to external scientific publications and presentations • Report to the Executive Director, Clinical Pharmacology

🎯 Exigences

• PhD or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline, or a graduate degree in these areas with a strong demonstrated work history • 3+ years of industry experience in clinical pharmacology or pharmacometrics within biotech, pharmaceutical, or drug development environments; relevant postdoctoral experience considered • Solid working knowledge of PK/PD theory, ADME, DDI mechanisms including in vitro-to-clinical translation, and MIDD principles • Hands-on proficiency with NONMEM, Phoenix WinNonlin/NLME, Monolix, R, or similar software • Ability to choose an appropriate analysis, troubleshoot model problems, and clearly explain a model's assumptions and limitations • Working knowledge of FDA, EMA, and ICH guidance relevant to clinical pharmacology, including ICH M12 and ICH M15 • Interest in translational medicine, including target engagement, biomarkers, and nonclinical-to-clinical translation • Ability to work effectively in cross-functional, matrixed environments • Excellent communication and stakeholder management skills • Exposure to PBPK platforms such as Simcyp, GastroPlus, or PK-Sim, or QSP modeling is a plus • Curiosity and passion for the work • Ability to embrace ambiguity and push for new practices and technologies • Adaptive problem-solving ability • Technical depth and growth mindset • Curiosity and drive for self-identified innovation, especially in artificial intelligence and digital exploration

🏖️ Avantages

• Company bonus depending in part on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical benefits • Dental benefits • Vision benefits • Prescription drug benefits • 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

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