Lilly
Healthcare
PK/PDOperationsAssociate
Neural analysis suggests this role is
optimal for Mid candidates.
“PK/PD Operations Associate at Lilly. Skills: PK/PD Operations, NCA Oversight, Clinical Operations Support. Manage and track timelines for clinical PK/PD deliverables. Perform and coordinate Quality Check (QC)”
What You'll Achieve.
Ensuring high quality and on-time delivery; Ensuring timely and high-quality execution; Achieve project milestones
Industry & Context.
Streamline and automate for continuous improvement; Process improvement initiatives; Streamline and automate such processes
What They're Looking For.
Must Have
BSc or MS in a relevant scientific field, such as biological/pharmaceutical sciences, chemistry, engineering, statistics, data science or a health-related field or Doctor of Pharmacy (PharmD), Minimum of 3 years of industry/regulatory experience with a background in clinical pharmacokinetics or a closely related field, Extensive knowledge of pharmacokinetics, including drug metabolism and PK/PD evaluation, and a sound awareness of current developments in drug development and regulatory sciences, Hands-on expertise in PK data analysis using industry-standard tools such as Phoenix WinNonlin and R, Excellent interpersonal and communication skills, with a proven ability to collaborate effectively with both internal teams and external partners
Nice to Have
Demonstrated success operating in a cross-functional, matrixed, project-team environment, with the ability to drive alignment and deliver results across organisational boundaries, An influential teammate and skilled negotiator, with oral and written communication abilities and the confidence to engage effectively with diverse stacollaborators all levels, understanding of clinical pharmacology principles, including pharmacokinetics, pharmacodynamics, and pharmacometrics, and their application in drug development, Proficiency in programming or statistical languages (e. g. , R, SAS) to support data analysis and operational automation, Self-directed and adaptable, with a track record of working independently and thriving in a dynamic, fast-paced environment with evolving priorities
What You'll Do.
Manage and track timelines for clinical PK/PD deliverables
Perform and coordinate Quality Check (QC)
Oversee and support NCA activities
Conduct and coordinate Quality Check (QC)
Maintain relationships with NCA vendors
Provide end-to-end operational support
Contribute to process improvement initiatives
Function as process driver for PK/PD-owned processes
Oversee outsourced PK/PD activities
Ensure contractual obligations are met
or serve as content expert for departmental SOPs
Ensure compliance with relevant regulatory guidelines
Perform quality checks and quality review of datasets
Work closely with cross-functional teams
How You'll Work.
Team & Collaboration
Collaborate effectively with both internal teams and external partners; Serve as a key liaison between clinical operations, data management, and PK/PD scientists; Work closely with cross-functional teams to drive integrated PK/PD strategies; Interact and communicate with coworkers outside PK/PD department
Communication Scope
Excellent interpersonal and communication skills; Oral and written communication abilities
Process & Methodology
Manage and track timelines, Coordinate study timelines and deliverables, Drive alignment and deliver results
Full 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
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