Senior Advisor, Clinical Pharmacology

🔥 il y a 6 heures

🇺🇸 États-Unis – Télétravail

💵 $168 000 - $268 400 / an

⏰ Temps Plein

🟠 Senior

👻 Score fantôme 0%

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

• 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 for Phase 1–2 studies, including FIH, SAD/MAD, DDI, food effect, organ impairment, and patient studies • Develop structural models, evaluate covariates, and perform model diagnostics • 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 data, 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, NDA, and MAA submissions • Collaborate with 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 and contribute to external scientific publications and presentations

🎯 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, passion for the work, adaptability, problem-solving ability, growth mindset, and interest in artificial intelligence and digital innovation

🏖️ 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 • 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 • Employee resource groups open to all employees

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