Sr Associate / Manager - Clinical Operations PK/PD
Join Eli Lilly and Company as a Sr Associate / Manager - Clinical Operations PK/PD.
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.
We’re looking for people who are determined to make life better for people around the world.
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.
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.
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.
* 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.
* Vendor Management: Oversee relationships with external vendors, including CROs (Contract Research Organizations) and other service providers.
* Compliance: Write, revise, review, or serve as content expert for departmental SOPs (Standard Operating Procedures) and methods, when appropriate.
* 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 pharmacometrics, 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 is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.
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.
#J-18808-Ljbffr