Clinical Advisor

• 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

Explore Senior Advisor, Clinical Pharmacology at Eli Lilly and Company. Review requirements and application details.

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