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 interpretation, study reports. Prepare relevant regulatory documents (INDs, IBs, CTDs) for development registration of new drugs line extensions across geographies. Apply PK/PD pharmacometric approaches to translate from preclinical clinical settings by integrating all relevant inputs. Communicate quantitative data;
Responsibilities
- Provide PK/PD scientific leadership to project teams to support the selection of the right dose patient population development strategies.
- Understand challenges faced during drug development process drive effective decision-making solutions.
- Lead PK/PD aspects of project team plans integrate quantitative approaches into drug development.
- Lead support preparation delivery of Phase I II III study protocols analysis plans data analysis interpretation study reports.
- Prepare relevant regulatory documents INDs IBs CTDs for development registration new drugs line extensions across geographies.
- Apply PK/PD pharmacometric approaches translate from preclinical clinical settings integrating all relevant inputs.
- Communicate quantitative data advocate model-based decision-making within project teams external stakeholders.
- Provide coaching mentoring scientists department beyond interact teach collaborate academia.','Represent group increase visibility externally through key publications active leadership key scientific organizations industry trade groups consortia.
Skills & Qualifications
- Ph.D. in Pharmaceutical Sciences Pharmacy Pharmacokinetics Clinical Pharmacology Pharmacometrics Engineering Statistics related discipline
Experience
- Minimum 4 years relevant drug development regulatory experience field PK/PD Pharmacometrics Clinical Pharmacology Translational Medicine closely related field.
- Thorough understanding experience applying pharmacokinetics pharmacodynamics pharmacometrics clinical pharmacology principles within drug development teams
- Track record applying model-informed drug development MIDD approaches inform drug development regulatory decision-making
- Hands-on experience applying non-linear mixed effect software principles such as NONMEM Monolix R physiologically-based pharmacokinetic PBPK modeling software principles such as SimCYP GastroPlus PK-Sim MATLAB R
- Excellent communication collaboration leadership skills ability influence cross-functional teams
- Strong track record scientific contributions field pharmacokinetics pharmacodynamics clinical pharmacology pharmaceutical sciences
Education
- Ph.D. in Pharmaceutical Sciences Pharmacy Pharmacokinetics Clinical Pharmacology Pharmacometrics Engineering Statistics related discipline
Why Join Us
- At Lilly we strive ensure employees part team cares about them shared purpose making life better people worldwide. Continue look ways include innovate accelerate deliver maintaining integrity excellence respect people.
Benefits
- Eligibility participate company-sponsored 401k pension vacation benefits eligibility medical dental vision prescription drug benefits flexible benefits e.g healthcare dependent daycare flexible spending accounts life insurance death benefits certain time off leave absence benefits well-being benefits e.g employee assistance program fitness benefits employee clubs activities Company bonus depending company performance