Senior Associate/Manager - Clinical Pharmacokinetics Operations (PK/PD)

About Eli Lilly Cork

Based in Cork, Ireland, Eli Lilly is a global healthcare leader striving to improve lives worldwide through innovative medicines and philanthropic efforts. The Cork site hosts over 2000 employees representing 60 nationalities, delivering value across various business services such as Finance, IT, Medical, and Clinical Trials. The campus offers top-tier facilities including flexible hybrid work, healthcare benefits, pension, life assurance, a subsidised canteen, onsite gym, parking, and travel subsidies. Comprehensive development support, educational assistance, and wellbeing initiatives foster a positive career environment.

Eli Lilly Cork promotes diversity, equity, and inclusion across ethnicity, cultural backgrounds, generations, gender, disabilities, and more, supported by dedicated networks and initiatives to ensure accessible environments and disability confidence.

Role Overview

The Clinical PK/PD Operations team supports drug discovery by managing key clinical pharmacokinetics/pharmacodynamics deliverables and streamlining operations in line with model-informed drug development. You will work closely with scientists and cross-functional groups to oversee deliverables, ensuring quality and timely completion. This position requires hands-on expertise in Non-Compartmental Analysis (NCA) with tools such as Phoenix WinNonlin or Monolix, and at least three years of clinical PK experience.

Responsibilities

• Manage and track timelines for clinical PK/PD deliverables including TFLs for study reports and regulatory submissions.
• Perform and coordinate Quality Check and Quality Review of PK/PD analyses, reports, and data.
• Oversee NCA operations ensuring quality execution and timely delivery across clinical studies.
• Manage vendor relationships related to NCA and outsourced PK/PD services ensuring compliance and quality standards.
• Review clinical dataset standards (SDTM, ADaM) pertinent to PK/PD and collaborate with data management to ensure data readiness.
• Support Phase 1-3 clinical operations by coordinating timelines, deliverables, dataset preparation, and PK/PD reporting milestones.
• Drive continuous process improvements and automation initiatives within PK/PD operations.
• Contribute to SOP development, compliance monitoring with regulatory guidelines, and quality assessments.
• Engage with cross-functional teams to integrate PK/PD strategies and serve as an operations expert on relevant committees.

Requirements

• Hands-on NCA data analysis experience with industry tools such as Phoenix WinNonlin, Monolix, and R; candidates lacking this hands-on skill do not meet minimal criteria.
• BSc or MSc in biological sciences, pharmaceutical sciences, chemistry, engineering, statistics, data science, health-related fields, or PharmD degree.
• At least 3 years of clinical pharmacokinetics experience in pharma, CRO, academia, or regulatory environments. Experience solely in QA, clinical trial coordination, or analytics without PK/PD background is insufficient.
• Thorough understanding of pharmacokinetics, drug metabolism, PK/PD evaluation, and current drug development regulatory knowledge.
• Strong interpersonal and communication skills to collaborate effectively with internal and external stakeholders.

Preferred Qualifications

• Proven success working in cross-functional, matrixed teams demonstrating alignment and delivery.
• Influential communicator with negotiation skills and confidence in engaging diverse stakeholders at multiple levels.
• In-depth knowledge of clinical pharmacology principles and their application in drug development.
• Proficiency in programming or statistical tools such as R or SAS to support data analysis and automate workflows.
• Self-motivated, adaptable to fast-paced environments with evolving priorities, able to work independently.

Diversity and Inclusion

Eli Lilly is committed to supporting individuals with disabilities, providing necessary accommodations during the application process, and fosters a non-discriminatory environment based on age, race, gender, sexual orientation, disability, and other protected statuses.