Director - PK​/PD & Pharmacometrics

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.

• 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

• 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, Gastro Plus, 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

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$177,000 - $308,000

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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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