Director - PK​/PD & Pharmacometrics

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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 worldwide 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.

• Provide PK/PD scientific leadership to project teams to support the selection notions of theosan and 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 ( mettent 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 cons proporciona.

• Ph.D. in Pharmaceutical Sciences, Pharmacy, Pharmac طرح, 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 Horrorto 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.

We are an EEO/Affirmative Action Employer. Lilly, Lilly USA, LLC and our wholly owned subsidiaries (collectively Lilly
) are committed to ensuring equal opportunity for all and do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

The anticipated wage for this position is $177,000 - $308,000.