Senior PK/PD Operations Lead: NCA & Data Automation

Eli Lilly and Company; Cork; Hybrid; EUR 85,000 - 130,000; Full time

Benefits offered by this job

Flexible hybrid working

Healthcare

Pension

Life assurance

On-site parking

On-site gym

Travel subsidies

Educational assistance

Wellbeing initiatives

Job summary

Eli Lilly Cork is recruiting for a Senior Associate/Manager in Clinical PK/PD Operations to support drug discovery and clinical development programs. You will oversee PK/PD deliverables, ensure data quality, and work with PK/PD scientists and cross-functional teams to drive on-time delivery.

Responsibilities include managing NCA activities, coordinating QC/QR, and contributing to process improvements and automation within PK/PD operations.

Qualifications

• Hands-on experience in PK/NCA data analysis using industry-standard tools such as Phoenix WinNonlin, Monolix and R.
• Minimum of 3 years of industry/regulatory experience with a background in clinical pharmacokinetics or a closely related discipline.
• Experience with SDTM/ADaM datasets and CDISC standards is desirable.

Responsibilities

• Manage and track timelines for clinical PK/PD deliverables, including Tables, Figures, and Listings for clinical study reports and regulatory submissions.
• Coordinate Quality Check and Quality Review of PK/PD analyses, reports, and supporting documentation.
• Provide end-to-end operational support across Phase 1 through Phase 3 PK/PD studies, including datasets preparation and PK/PD reporting milestones.
• Oversee outsourced PK/PD activities including NCA vendor management and CRO relationships, ensuring timely delivery and compliance.

Skills

PK/NCA data analysis

Phoenix WinNonlin

Monolix

R

Education

BSc or MS in relevant scientific field

PharmD

Tools

Phoenix WinNonlin

Monolix

R

Job description

Eli Lilly Cork is recruiting for a Senior Associate/Manager in Clinical PK/PD Operations to support drug discovery and clinical development programs. You will oversee PK/PD deliverables, ensure data quality, and work with PK/PD scientists and cross-functional teams to drive on-time delivery.

Responsibilities include managing NCA activities, coordinating QC/QR, and contributing to process improvements and automation within PK/PD operations.