Director - PK/PD & Pharmacometrics
Eli Lilly and Company
2 months ago
Remote friendly (Indianapolis, IN)
United States
$177,000 - $308,000 USD yearly
Clinical Research and Development
Responsibilities:
- Provide PK/PD scientific leadership to project teams to support selection of the right dose, patient population, and development strategies.
- Understand drug development challenges 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 preparation and delivery of Phase I, II, and III study protocols, analysis plans, data analysis/interpretation, and study reports.
- Prepare 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.
- Communicate quantitative data and advocate for model-based decision-making within teams and to external stakeholders.
- Coach and mentor scientists; interact/teach/collaborate with academia.
- Represent the group via key publications and leadership in scientific organizations/industry groups/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 in PK/PD, Pharmacometrics, Clinical Pharmacology, Translational Medicine, or closely related field.
Additional Skills/Preferences:
- Thorough understanding/experience applying pharmacokinetics, pharmacodynamics, pharmacometrics, and clinical pharmacology in drug development teams.
- Track record using model-informed drug development (MIDD) for drug development and/or regulatory decisions.
- Hands-on experience with NONMEM, Monolix, R and/or PBPK tools (SimCYP, GastroPlus, PK-Sim, MATLAB, R).
- Excellent communication, collaboration, and leadership; ability to influence cross-functional teams.
- Strong scientific publication/contribution record in PK/PD/clinical pharmacology/pharmaceutical sciences.
Benefits (if applicable):
- Full-time employees may be eligible for a company bonus.
- Comprehensive benefits program including 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
Application instructions:
- If you require accommodation to submit a resume, email Lilly Human Resources at Lilly_Recruiting_Compliance@lists.lilly.com (intended only for accommodation requests).
- Provide PK/PD scientific leadership to project teams to support selection of the right dose, patient population, and development strategies.
- Understand drug development challenges 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 preparation and delivery of Phase I, II, and III study protocols, analysis plans, data analysis/interpretation, and study reports.
- Prepare 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.
- Communicate quantitative data and advocate for model-based decision-making within teams and to external stakeholders.
- Coach and mentor scientists; interact/teach/collaborate with academia.
- Represent the group via key publications and leadership in scientific organizations/industry groups/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 in PK/PD, Pharmacometrics, Clinical Pharmacology, Translational Medicine, or closely related field.
Additional Skills/Preferences:
- Thorough understanding/experience applying pharmacokinetics, pharmacodynamics, pharmacometrics, and clinical pharmacology in drug development teams.
- Track record using model-informed drug development (MIDD) for drug development and/or regulatory decisions.
- Hands-on experience with NONMEM, Monolix, R and/or PBPK tools (SimCYP, GastroPlus, PK-Sim, MATLAB, R).
- Excellent communication, collaboration, and leadership; ability to influence cross-functional teams.
- Strong scientific publication/contribution record in PK/PD/clinical pharmacology/pharmaceutical sciences.
Benefits (if applicable):
- Full-time employees may be eligible for a company bonus.
- Comprehensive benefits program including 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
Application instructions:
- If you require accommodation to submit a resume, email Lilly Human Resources at Lilly_Recruiting_Compliance@lists.lilly.com (intended only for accommodation requests).