Sr Associate / Manager - Clinical Operations PK / PD

JOB DESCRIPTION

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!

Reports to : PK / PD Operations Lead

We are the Global Pharmacokinetics / Pharmacodynamics (PK / PD) and Pharmacometrics Department at Lilly, and we're looking for talent to join our newly formed PK / PD Operations Team. 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 PK / PD Operations Team will work to streamline, manage, and oversee departmental deliverables.

As a PK / PD Operations Associate, 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. 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 data scientists, project managers, clinical operations specialists or general scientists 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 :

• PK / PD Process Oversight : Collaborate with PK / PD scientists to develop data analysis plans, oversee timelines for document preparation and submission, and coordinate / prepare drafts of PK / PD documents.
• Data Management & Analysis : Collaborate with data management teams to ensure accurate collection, processing, delivery and analysis of PK / PD data, adhering to established standards and protocols. Create and / or review clinical trial datasets for key PK analyses. Perform basic PK and / or PK / PD analyses and prepare graphs and tables to communicate analysis results clearly and concisely.
• Issue Resolution : Identify and address operational challenges promptly, implementing effective solutions to mitigate risks and ensure successful delivery of PK / PD analyses and documents.
• 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.
• Vendor Management : Oversee relationships with external vendors, including CROs (Contract Research Organizations) and other service providers, to ensure timely delivery of high-quality studies, datasets, analyses or submission activities.
• 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. 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.

Basic Requirements :

Additional preferred criteria

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 (

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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