Director - PK/PD & Pharmacometrics

Eli Lilly and Company•Us, IN

14h•$177,000 - $308,000

About The Position

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 are the Global Pharmacokinetics/Pharmacodynamics and Pharmacometrics Department at Lilly, and we're looking for top talent to join our team. Our PK/PD & Pharmacometrics scientists are the functional leaders from drug discovery to clinical development, approval, and life-cycle management. We work with the goal of identifying the right dose of the right drug for the right patient and living the model-informed drug discovery and development (MIDD) paradigm. We seek dynamic, energetic, curious, and collaborative scientists ready to engage and work on life-changing therapies for patients. We are passionate about making an impact in the lives of our patients and pushing the boundaries of science. Consider joining Team Lilly in Indianapolis to contribute to Lilly's drug discovery and development efforts. Responsibilities: You will be responsible for applying PK/PD and Clinical Pharmacology scientific acumen on 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 dose, patient population, and development strategies. Understand the challenges faced during the drug development process and drive effective decision-making and solutions. Lead PK/PD aspects of project team plans and integrate quantitative approaches into drug development. Lead and support the preparation and delivery of Phase I, II, and III study protocols, analysis plans, data analysis and interpretation, and study reports. Prepare relevant regulatory documents (INDs, IBs, CTDs, etc.) for development and registration of new drugs and line extensions across geographies. Apply PK/PD and pharmacometric approaches to translate from preclinical to clinical settings by integrating all relevant inputs. Communicate quantitative data and advocate for model-based decision-making within project teams and to external stakeholders. Provide coaching and mentoring to other scientists within the department and beyond; interact, teach, 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.

Requirements

Ph.D. in Pharmaceutical Sciences, Pharmacy, Pharmacokinetics, Clinical Pharmacology, Pharmacometrics, Engineering, Statistics, or a related discipline
At least 7 years of relevant drug development and regulatory experience within the field of PK/PD, Pharmacometrics, Clinical Pharmacology, Translational Medicine, or a closely related field

Nice To Haves

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 drug development and/or regulatory decision-making
Hands-on experience applying non-linear mixed effect software and principles such as NONMEM, Monolix, and R, and/or physiologically-based pharmacokinetic (PBPK) modeling software and principles such as SimCYP, GastroPlus, PK-Sim, MATLAB, and R
Excellent communication, collaboration, and leadership skills and the ability to influence cross-functional teams
Strong track record of scientific contributions to the field of pharmacokinetics, pharmacodynamics, clinical pharmacology, and/or pharmaceutical sciences

Responsibilities

Provide PK/PD scientific leadership to project teams to support the selection of the right dose, patient population, and development strategies.
Understand the challenges faced during the drug development process and drive effective decision-making and solutions.
Lead PK/PD aspects of project team plans and integrate quantitative approaches into drug development.
Lead and support the preparation and delivery of Phase I, II, and III study protocols, analysis plans, data analysis and interpretation, and study reports.
Prepare relevant regulatory documents (INDs, IBs, CTDs, etc.) for development and registration of new drugs and line extensions across geographies.
Apply PK/PD and pharmacometric approaches to translate from preclinical to clinical settings by integrating all relevant inputs.
Communicate quantitative data and advocate for model-based decision-making within project teams and to external stakeholders.
Provide coaching and mentoring to other scientists within the department and beyond; interact, teach, 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.

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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