Senior Executive Director, PK/PD & Pharmacometrics

Eli Lilly and Company; Indianapolis (IN); Hybrid; USD 250,000 - 320,000; Full time

Job summary

Eli Lilly and Company in Indianapolis and Bracknell seeks a Director–Executive Director for PK/PD & Pharmacometrics. Lead modeling, regulatory strategy, and cross-functional teams to drive drug development decisions. Drives model-informed drug discovery across multiple programs and geographies.

The role requires a PhD with extensive PK/PD expertise, strong communication, and a track record in regulatory interactions. Hybrid work setup with global collaboration and leadership responsibilities.

Qualifications

• PhD in a relevant discipline with 8+ years of PK/PD or Clinical Pharmacology experience.
• Strong understanding of pharmacokinetics, pharmacodynamics, pharmacometrics, and clinical pharmacology principles.
• Experience with regulatory interactions (FDA, EMA, PMDA, etc.).

Responsibilities

• Provide PK/PD leadership to project teams to support target, molecule, dose, and population decisions.
• Lead exploratory MIDD and PK/PD analyses across development stages.
• Drive data-driven decision-making and provide solutions to development challenges.
• Lead and coordinate PK/PD aspects of program plans and integration into discovery or development.
• Support preparation of study protocols, analysis plans, data interpretation, and reports for Phase I–III.
• Prepare regulatory documents (INDs, IBs, CTDs) for global submissions and interact with agencies.
• Communicate quantitative data clearly and advocate model-based decisions with stakeholders.
• Mentor scientists and collaborate with academia; increase external visibility via publications.

Skills

PK/PD expertise

Clinical pharmacology

Regulatory interactions

Cross-functional collaboration

Quantitative modeling

Communication skills

Education

PhD in a relevant discipline

Job description

Eli Lilly and Company in Indianapolis and Bracknell seeks a Director–Executive Director for PK/PD & Pharmacometrics. Lead modeling, regulatory strategy, and cross-functional teams to drive drug development decisions. Drives model-informed drug discovery across multiple programs and geographies.

The role requires a PhD with extensive PK/PD expertise, strong communication, and a track record in regulatory interactions. Hybrid work setup with global collaboration and leadership responsibilities.