At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world.
The Global PK/PD and Pharmacometrics Department is the functional leader in R&D across the value chain. We are seeking a dynamic, curious, and collaborative scientist to provide PK/PD scientific leadership on project teams.
MAIN RESPONSIBILITIES INCLUDE:- Provide PK/PD and quantitative clinical pharmacology leadership to project teams.
- Conduct exploratory MIDD and PK/PD analysis across development stages.
- Lead PK/PD aspects of program and product team plans.
- Lead preparation of Phase I, II and III protocols, analysis plans and study reports.
- Prepare INDs, IBs, CTDs and other regulatory documents, interacting with FDA, EMA, PMDA and other agencies.
- Communicate quantitative data and advocate model-based decision making with senior stakeholders.
- Provide coaching and mentoring; collaborate with academia.
- Represent the group through publications and scientific organizations.
BASIC REQUIREMENTS:- PhD in a relevant discipline and at least 8 years of relevant work experience in PK/PD or Clinical Pharmacology.
ADDITIONAL SKILLS & PREFERENCES:- Thorough understanding of pharmacokinetics, pharmacodynamics and pharmacometrics.
- Strong cross-functional collaboration and communication skills.
- Experience with regulatory interactions preferred.
Lilly does not discriminate on the basis of age, race, colour, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.