Senior Advisor, Clinical Pharmacology

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $168k - $268.4k / year

⏰ Full Time

🟠 Senior

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a global pharmaceutical company that researches, develops, manufactures, and distributes prescription medicines and provides patient support services. The company focuses on life-changing medicines across conditions such as diabetes, cancer, Alzheimer’s disease, autoimmune disorders, dermatology, migraine, obesity, and sleep apnea; it runs clinical trials, offers LillyDirect pharmacy services, and emphasizes manufacturing quality, medication safety, and research into genetic medicines. Eli Lilly also provides patient resources, condition education, and access programs to help people find care and participate in trials.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

• 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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