Director - Pk/Pd & Pharmacometrics

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

We're the Global PK/PD and Pharmacometrics Department at Lilly, seeking top talent. Our scientists lead from drug discovery through to clinical development, approval, and beyond. Our aim is to find the right dose of the right drug for the right patient, embodying the model-informed drug discovery and development (MIDD) paradigm.

We seek dynamic, upbeat, curious, and collaborative scientists ready to engage and work on life-changing therapies for patients. Are you passionate about making an impact in the lives of patients and pushing the boundaries of science? Consider joining Team Lilly in Indianapolis to contribute to Lilly’s drug discovery and development efforts!

This role lets you apply your PK/PD and Clinical Pharmacology expertise as a key member of our project teams. We are seeking quantitative-minded scientists who will:

• Provide PK/PD scientific leadership to project teams to support the selection of the right target, molecule, dose, patient population, and development strategies.
• Apply PK/PD and pharmacometric approaches to translate from preclinical to the clinical setting by integrating all relevant inputs.
• Understand the challenges faced during the drug discovery/development process and drive effective decision-making and solutions.
• Lead PK/PD aspects of project team plans and integrate quantitative approaches into drug discovery and/or development
• Take charge of and assist in creating and presenting Phase I, II, and III study protocols, analysis plans, interpreting data, and preparing study reports.
• Prepare INDs, IBs, CTDs and other regulatory documents for development and registration of new drugs and line extensions across geographies. This may involve preparation of response documents as well as direct interactions with regulatory agencies.
• Communicate quantitative data and advocate for model-based decision making within project teams and to external partners
• Mentor other scientists within the department and beyond; Interact, instruct, and collaborate with academia.
• Represent the group to increase visibility externally, through key publications, active leadership in key scientific organizations, industry trade groups, or consortia.

• PhD and/or MD in Pharmacokinetics/Pharmacodynamics, Clinical Pharmacology, Pharmacometrics, Computational Sciences, Engineering, Statistics, or a related field
• At least 5 years of relevant work experience

• Detailed understanding and experience of applying pharmacokinetics, pharmacodynamics, pharmacometrics and clinical pharmacology principles within drug development teams

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