Senior Associate/ Manager - Clinical Pharmacokinetics Operations Associate (PK/PD)
Role Overview
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.
Primary Responsibilities
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.
Requirements and Qualifications
* Minimum of ~3 years in clinical pharmacokinetics.
* Hands-on non-compartmental analysis experience using industrial tools like Phoenix WinNonlin or Monolix.
* Strong foundation in clinical pharmacokinetics from pharma, CRO, academic, or regulatory backgrounds.
* Experience reviewing SDTM (PC, PP, EX, VS, LB, DM) and ADaM (ADNCA, ADPC, ADPP, ADSL) datasets in a clinical PK/PD context.
* Working knowledge of CDISC standards.
* Ability to liaise with data management teams to ensure data quality and readiness for analysis.
What They Offer
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.