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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. 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.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

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.

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 s erve 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.

Basic Requirements:

Hands-on expertise in PK   (NCA)   data analysis using industry-standard tools such as Phoenix WinNonlin , Monolix   and R .   Candidates without hands-on NCA experience using industry-standard tools do not meet the minimum technical requirement .

BSc or MS in relevant scientific field, such as biological/pharmaceutical sciences, chemistry, engineering, statistics, data science or health-related discipline or Doctor of Pharmacy (PharmD) .

Minimum of   3   years of industry /regulatory   experience with a background in clinical pharmacokinetics or a closely related discipline.   Experience in QA, clinical trial   coordination, or general data analytics without PK/PD grounding does not satisfy this requirement .

Extensive knowledge of pharmacokinetics, including drug metabolism and PK/PD evaluation, and a sound awareness of current developments in drug development and regulatory sciences.

Excellent interpersonal and communication skills, with a proven ability to collaborate effectively with both internal teams and external stakeholders.

Additional preferred criteria

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 .

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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