Clinical Pharmacology Lead — PK/PD & Modeling

Eli Lilly and Company

United States

Remote

USD 153,000 - 268,000

Full time

3 days ago
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Benefits offered by this job

Performance bonus
401(k) plan with company match
Healthcare, dental, vision benefits
Paid time off

Job summary

Lilly in Indianapolis, IN is seeking a Senior Advisor, Clinical Pharmacology to lead quantitative PK/PD work for early- to mid-stage clinical programs. You will build and interpret PK/PD models, translate nonclinical data to humans, and shape dose/exposure decisions in cross‑functional teams.

The role demands deep pharmacometrics expertise, regulatory awareness, and a collaborative, problem-solving mindset in a fast-paced environment.

Qualifications

  • PhD or PharmD in Clinical Pharmacology or related discipline.
  • 3+ years in clinical pharmacology or pharmacometrics in biotech/pharma.
  • Strong PK/PD, ADME, DDI knowledge and translational skills.
  • Experience with regulatory guidance (FDA/EMA/ICH) preferred.

Responsibilities

  • Provide PK/PD input to dose, population, and study design decisions.
  • Perform noncompartmental and population PK analyses for Phase 1–2 studies.
  • Develop exposure–response and PBPK analyses to aid dose selection.
  • Translate nonclinical data to clinical projections and SM/DDI risk.
  • Draft PK/PD sections for clinical development plans and regulatory documents.
  • Lead CRO oversight and present findings to stakeholders.

Skills

PK/PD modelling
NONMEM
R / NLME
Pharmacometrics
Cross-functional collab

Education

PhD or PharmD in Clinical Pharmacology or related
3+ years industry experience in pharmacology

Tools

Phoenix WinNonlin
Monolix
NONMEM
R

Job description

Lilly in Indianapolis, IN is seeking a Senior Advisor, Clinical Pharmacology to lead quantitative PK/PD work for early- to mid-stage clinical programs. You will build and interpret PK/PD models, translate nonclinical data to humans, and shape dose/exposure decisions in cross‑functional teams.

The role demands deep pharmacometrics expertise, regulatory awareness, and a collaborative, problem-solving mindset in a fast-paced environment.

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