Sr Associate

Sr Associate / Manager - Clinical Operations PK/PD page is loaded Sr Associate / Manager - Clinical Operations PK/PD Apply locations IE: Global Business Solutions - Cork time type Full time posted on Posted 2 Days Ago job requisition id R-60844

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.

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. We’re looking for people who are determined to make life better for patients around the world.

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. 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:

• 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.

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.

#WeAreLilly

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe