Senior Advisor, Clinical Pharmacology

🔥 4 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $153k - $268.4k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 0%

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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 multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 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 • 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 • 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 and participate in peer review of analyses and reports • Present findings to internal stakeholders and contribute to external scientific publications and presentations • Report to the Executive Director, Clinical Pharmacology • Build, evaluate, and explain quantitative models and take growing ownership of clinical pharmacology deliverables within project teams

🎯 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

🏖️ Benefits

• Company bonus depending, in part, on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and 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