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Sr Associate / Manager - Clinical Operations PK/PD, Cork
Client:
Lilly
Location:
Cork, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
31107afe6871
Job Views:
7
Posted:
15.03.2025
Expiry Date:
29.04.2025
Job Description:
We’re looking for people who are determined to make life better for people around the world.
Organisation Overview:
At Eli Lilly Cork, 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 41,000 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.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 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, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network.
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. 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.
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.
* 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.
Basic Requirements:
* 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)
* Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
Additional preferred criteria:
* Good understanding of clinical pharmacology (PK, PD and pharmacometrics) principles.
* Working knowledge of programming or statistical languages.
* Working experience with industry, regulatory, consulting, or academia.
* Experience or background in Project Management, with excellent organizational and time management skills.
* Proven ability to work independently and adapt to evolving priorities in a fast-paced environment.
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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