Senior Clinical Pharmacology Scientist: PK/PD & Modeling

Eli Lilly and Company; Indianapolis (IN); Sur place; USD 153 000 - 268 000; Plein temps

Avantages offerts par ce poste

Annual bonus

401(k) plan

Comprehensive benefits

Paid time off

Résumé du poste

Eli Lilly and Company is seeking a Senior Advisor, Clinical Pharmacology to bring deep PK/PD and pharmacometrics expertise to our clinical programs. You will translate nonclinical and biomarker data into clinical decisions and actively contribute to dose selection and study design in a fast-paced environment.

Reporting to the Executive Director, Clinical Pharmacology, you will work across DMPK, translational sciences, and clinical development, preparing regulatory documents and influencing

Qualifications

• PhD or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmacokinetics, Pharmaceutical Sciences, or related discipline; or graduate degree with strong work history.
• 3+ years of industry experience in clinical pharmacology/pharmacometrics in biotech/pharma.
• Solid knowledge of PK/PD theory, ADME, DDI, and MIDD.
• Hands-on proficiency with NONMEM, Phoenix WinNonlin/NLME, Monolix, R, or similar software.
• Ability to explain model assumptions and limitations clearly.
• Working knowledge of FDA/EMA/ICH guidance related to clinical pharmacology.

Responsabilités

• Provide clinical pharmacology and PK/PD input to project teams for dose, patient population, and study design decisions.
• Conduct noncompartmental and population PK analyses, model diagnostics, covariate evaluation for Phase 1–2 studies.
• Build exposure–response and PK/PD analyses and PBPK models for dose selection and DDI risk assessment.
• Integrate nonclinical PK/PD, ADME, and biomarker data to support human PK and dose projections and first-in-human rationale.
• Draft PK/PD sections of development plans, protocols, analysis plans, and regulatory documents (IND, CTA, NDA/MAA).
• Collaborate with DMPK, translational sciences, clinical development, bioanalysis, biostatistics, and regulatory affairs.
• Provide day-to-day oversight of CROs and vendor deliverables; participate in peer reviews.
• Present findings to internal stakeholders and contribute to publications and presentations.

Connaissances

Clinical pharmacology

PK/PD theory

Cross-functional teamwork

Communication

Formation

PhD or PharmD in Clinical Pharmacology

Outils

NONMEM

Phoenix WinNonlin/NLME

Monolix

R

Description du poste

Eli Lilly and Company is seeking a Senior Advisor, Clinical Pharmacology to bring deep PK/PD and pharmacometrics expertise to our clinical programs. You will translate nonclinical and biomarker data into clinical decisions and actively contribute to dose selection and study design in a fast-paced environment.

Reporting to the Executive Director, Clinical Pharmacology, you will work across DMPK, translational sciences, and clinical development, preparing regulatory documents and influencing