Director - PK/PD & Pharmacometrics

We are the Global Pharmacokinetics/Pharmacodynamics and Pharmacometrics Department at Lilly, seeking top talent to join our team. Our scientists lead projects from drug discovery to clinical development, aiming to identify the right dose for the right patient through model‑informed drug discovery and development (MIDD).

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 scientific organizations, industry trade groups, or consortia.

Basic Qualifications

• 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 PK/PD, Pharmacometrics, Clinical Pharmacology, Translational Medicine, or a closely related field.

Additional Skills/Preferences

• Thorough understanding and experience in 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 with non‑linear mixed‑effect software such as NONMEM, Monolix, and R, and/or physiologically‑based pharmacokinetic (PBPK) modeling software 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 pharmacokinetics, pharmacodynamics, clinical pharmacology, and/or pharmaceutical sciences.

Compensation and Benefits

Salary range: $177,000 – $308,000 per year (full‑time equivalent). Eligible for company bonus, 401(k) matching, pension, vacation, medical, dental, vision, and prescription drug benefits, flexible spending accounts, life and disability insurance, well‑being benefits, and employee assistance program. Lilly reserves the right to modify its compensation and benefit programs.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sexual orientation, disability, or any other legally protected status.

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