Sr Associate / Manager - Clinical Operations PK/PD

Key Skills

Data Analysis, Data management, Data science techniques, Operations

Job Description

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:

• 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.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.