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

We are the Global Pharmacokinetics/Pharmacodynamics (PK/PD) and Pharmacometrics Department at Lilly, and we're looking for talent to join our Clinical newly formed PK/PD Operations Team based in Cork, Ireland. We work with the goal of identifying the right dose of the right drug for the right patient and living the model-informed drug discovery and development (MIDD) paradigm. The Clinical PK/PD Operations Team will work to streamline, manage, and oversee departmental deliverables. 

As a Sr. Associate/Manager in Clinical Operations PK/PD, you will play a critical role in supporting the operational aspects of our drug discovery and clinical development programs. You will work closely with PK/PD scientists and cross-functional teams to oversee key PK/PD deliverables, ensuring high quality and on-time delivery. This role requires hands-on non-compartmental analysis using any industrial tools like Phoenix WinNonlin, Monolix experience and a minimum of ~3 years in clinical pharmacokinetics - applications without this background will not meet the minimum requirements. Your primary focus will Non-Compartmental Analysis (NCA) oversight, Phase 1 and Phase 2/3 clinical operations support, submissions operations, outsourcing oversight, and vendor management. You will apply your knowledge of data science, clinical trial operations, PK/PD or related scientific and technical knowledge to streamline and automate for continuous improvement. 

We seek dynamic, energetic, curious, and collaborative professionals with a strong foundation in clinical pharmacokinetics — from pharma, CRO, academic, or regulatory backgrounds with a passion for operations, ready to engage and work on life-changing therapies for patients. We are passionate about making an impact in the lives of our patients and pushing the boundaries of science. Consider joining Team Lilly in Cork to contribute to Lilly’s drug discovery and development efforts. 

• Clinical PK/PD Operations: Manage and track timelines for clinical PK/PD deliverables, including Tables, Figures, and Listings (TFLs) for clinical study reports and regulatory submissions. Perform and coordinate Quality Check (QC) and Quality Review (QR) activities to ensure accuracy and completeness of PK/PD analyses, reports, and supporting documentation. 

• Non-Compartmental Analysis (NCA) Operations: Oversee and support NCA activities across clinical programs, ensuring timely and high-quality execution. Conduct and coordinate Quality Check (QC) and Quality Review (QR) of NCA outputs, with primary focus on NCA deliverables today and expanding scope planned for future. Manage relationships with NCA vendors, ensuring contractual compliance, quality standards, and on-time delivery. Experience reviewing SDTM (PC, PP, EX, VS, LB, DM) and ADaM (ADNCA, ADPC, ADPP, ADSL) datasets in a clinical PK/PD context, with working knowledge of CDISC standards and the ability to liaise with data management teams to ensure data quality and readiness for analysis. 

• Phase 1-3 Clinical Operations Support: Provide end-to-end operational support across Phase 1 through Phase 3 PK/PD studies, including coordinating study timelines and deliverables, supporting dataset preparation, and managing PK/PD reporting milestones. Serve as a key liaison between clinical operations, data management, and PK/PD scientists to ensure seamless communication and cross-functional alignment — from first-in-human and early-phase programs through to later-phase clinical development - ensuring operational excellence at every stage of the program 

• Continuous Improvement & Automation: Contribute to process improvement initiatives to enhance the efficiency and quality of PK/PD operations, leveraging best practices and innovative approaches. Function as process driver for PK/PD-owned processes, acting to streamline and automate such processes. 

• Outsourcing & Vendor Oversight: Oversee outsourced PK/PD activities including NCA vendor management, CRO (Contract Research Organization) relationships, and other third-party service providers. Ensure contractual obligations are met, deliverable quality is maintained, and timelines are adhered to. Serve as the primary point of contact for vendor operational issues, escalating risks as needed. 

• Compliance: Write, revise, review, or serve as content expert for departmental SOPs (Standard Operating Procedures) and methods, when appropriate. Ensure compliance with relevant regulatory guidelines and internal SOPs. Perform quality checks and quality review of datasets, analyses and reports for completeness and accuracy. 

• Cross-Functional Collaboration: Work closely with cross-functional teams to drive integrated PK/PD strategies and achieve project milestones. Might serve as PK/PD Operations expert on appropriate intra-departmental committees. Interact and communicate with coworkers outside PK/PD department to facilitate and resolve issues pertaining to the timely completion of PK/PD deliverables. 

• Demonstrated success operating in a cross-functional, matrixed, project-team environment, with the ability to drive alignment and deliver results across organisational boundaries. 

• An influential team player and skilled negotiator, with strong oral and written communication abilities and the confidence to engage effectively with diverse stakeholders at all levels. 

• Strong understanding of clinical pharmacology principles, including pharmacokinetics, pharmacodynamics, and pharmacometrics, and their application in drug development. 

• Proficiency in programming or statistical languages (e.g., R, SAS) to support data analysis and operational automation. 

• Self-directed and adaptable, with a track record of working independently and thriving in a dynamic, fast-paced environment with evolving priorities.