Senior Advisor - PK/PD & Pharmacometrics Project Leader

Role Summary

Senior Advisor - PK/PD & Pharmacometrics Project Leader applies PK/PD, pharmacometrics, and clinical pharmacology expertise to project teams to support optimal dosing and development strategies across Phase I–III. The role translates preclinical data to clinical settings using model-informed drug discovery and development (MIDD) approaches, leads PK/PD activities within programs, and mentors colleagues. This position is based in Indianapolis, IN, with opportunities to contribute to publications and scientific leadership.

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 publications, leadership in scientific organizations, industry groups, or consortia.

Qualifications

• Required: Ph.D. in Pharmaceutical Sciences, Pharmacy, Pharmacokinetics, Clinical Pharmacology, Pharmacometrics, Engineering, Statistics, or a related discipline.
• Required: Minimum of 4 years of relevant drug development and regulatory experience within the field of PK/PD, Pharmacometrics, Clinical Pharmacology, Translational Medicine, or a closely related field.
• Preferred: Thorough understanding and experience applying pharmacokinetics, pharmacodynamics, pharmacometrics, and clinical pharmacology principles within drug development teams.
• Preferred: Track record of applying model-informed drug development (MIDD) approaches to inform drug development and/or regulatory decision-making.
• Preferred: 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.
• Preferred: Excellent communication, collaboration, and leadership skills and the ability to influence cross-functional teams.
• Preferred: Strong track record of scientific contributions to the field of pharmacokinetics, pharmacodynamics, clinical pharmacology, and/or pharmaceutical sciences.