Senior Advisor, Clinical Pharmacology & PK/PD Modeling

BioSpace; Indianapolis (IN); Presencial; USD 153.000 - 268.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus program

Comprehensive benefits

Descripción de la vacante

Lilly in Indianapolis seeks a Senior Advisor, Clinical Pharmacology to lead PK/PD modeling for early and mid-stage programs. You will build and interpret population PK analyses, translate nonclinical data into clinical decisions, and contribute to dose selection and study designs.

You will collaborate with DMPK, translational sciences, regulatory affairs, and project leadership, oversee CROs, and help prepare regulatory documents. A PhD/PharmD and 3+ years of industry experience are required.

Formación

• PhD or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmacokinetics, Pharmaceutical Sciences, or related field.
• 3+ years of industry experience in clinical pharmacology/pharmacometrics.
• Strong knowledge of PK/PD, ADME, DDI, and MIDD principles.
• Experience with NONMEM, Phoenix WinNonlin/NLME, Monolix, R or similar tools.
• Ability to explain model assumptions and limitations clearly.

Responsabilidades

• Provide clinical pharmacology and PK/PD input to project teams for dose and study design decisions.
• Conduct noncompartmental and population PK analyses for Phase 1–2 studies.
• Build exposure–response and PK/PD analyses and PBPK models.
• Integrate nonclinical PK/PD and biomarker data to support human PK and dose projections.
• Draft PK/PD sections for development plans, protocols, analyses, and regulatory documents.
• Collaborate across DMPK, translational sciences, clinical development, and regulatory affairs.
• Oversee CROs and vendor analyses; participate in peer reviews.
• Present findings to internal stakeholders and contribute to publications.

Conocimientos

PK/PD theory

Nonclinical to clinical translation

Cross-functional collaboration

Communication skills

Educación

PhD or PharmD in Clinical Pharmacology/Pharmacokinetics

Herramientas

NONMEM

Phoenix WinNonlin/NLME

Monolix

R

Descripción del empleo

Lilly in Indianapolis seeks a Senior Advisor, Clinical Pharmacology to lead PK/PD modeling for early and mid-stage programs. You will build and interpret population PK analyses, translate nonclinical data into clinical decisions, and contribute to dose selection and study designs.

You will collaborate with DMPK, translational sciences, regulatory affairs, and project leadership, oversee CROs, and help prepare regulatory documents. A PhD/PharmD and 3+ years of industry experience are required.