Advisor​/Senior Advisor - Clinical PK​/PD Project Leader

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, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

** Role Overview*
* The Global PK/PD and Pharmacometrics Department serves as the functional leader in research and development across the value chain - from preclinical lead molecule identification through clinical post-approval. Our mission is to accelerate the development of innovative medicines by applying mechanistic reasoning and quantitative modeling to complex systems. We partner across disciplines to simplify and enable critical decisions. We are leaders in model-informed drug discovery and development.

Using deep quantitative thinking, we work best with hard questions, and our insight shapes the medicines that reach patients.

** Role Overview*
* We are seeking a dynamic, curious, and collaborative Quantitative Clinical Pharmacologist ready to provide PK/PD scientific leadership on project teams and drive impactful, model-based decision-making across our portfolio.

Main Responsibilities

+ Provide PK/PD and quantitative clinical pharmacology scientific leadership to project teams to support selection of the right dose, patient population, and development strategy.

+ Partner with PBPK, QSP and Pharmacometrics modelers to bring the best quantitative answers and influence portfolio decisions

+ Conduct exploratory PK/PD analysis in early development stages.

+ Understand and anticipate high-level challenges in the drug development process and drive effective, data-driven decision-making and solutions.

+ Lead PK/PD aspects of program and product team plans as project leader; integrate quantitative approaches into drug development.

+ Lead and support preparation and delivery of Phase I, II, and III study protocols, analysis plans, data analysis and interpretation, and study reports.

+ Prepare relevant INDs, IBs, CTDs, and other regulatory documents supporting development and registration of new drugs and line extensions across multiple geographies; this may involve direct interaction with FDA, EMA, PMDA, and other regulatory agencies.

+ Communicate quantitative data clearly and advocate for model-based decision-making with cross-functional teams and senior stakeholders.

+ May coach and mentor other scientists within the department and beyond; interact, teach, and collaborate with academia.

+ May represent the group to increase external visibility through key publications and active leadership in scientific organizations, industry trade groups, or consortia.

** Basic Qualifications*
* + PhD in Pharmaceutical Sciences, Pharmacy, DMPK, Pharmacokinetics, Clinical Pharmacology, Pharmacometrics, Engineering, Statistics, or a related discipline.

+ Minimum of 2 years of relevant drug development and regulatory experience in areas such as Quantitative Clinical Pharmacology, Clinical PK/PD, Clinical PBPK modeling, and/or Pharmacometrics.

** Additional Skills/Preferences*
* + Thorough understanding and experience applying pharmacokinetics, pharmacodynamics, pharmacometrics, and clinical pharmacology principles within drug development teams.

+ Track record of applying model-informed drug development (MIDD) approaches to inform development and/or regulatory decision-making.

+ Hands-on experience with non-linear mixed-effect software and principles (NONMEM, Monolix, R) and/or PBPK modeling software (SimCYP, Gastro Plus, PK-Sim, MATLAB, R).

+ Excellent communication and collaboration skills; ability to influence cross-functional teams.

+ Strong track record of scientific contributions to the field of pharmacokinetics, pharmacodynamics, or clinical pharmacology.

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