Associate, Sr. Associate, Manager Pharmacoepidemiology Project Manager (PEPM)

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 Yourself!

Overview

The Pharmacoepidemiology Project Manager (PEPM) leads the cross-functional study team in the development and execution of pharmacoepidemiology (PE) trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. The senior PEPM Manager/Lead leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables.

The primary purpose of the GPS PEPM is to support the planning, contracting, execution and tracking of complex PE studies through the application of project management and expert knowledge in PE studies. This includes supporting teams on the delivery of cross-functional initiatives and projects, accountability for delivery of project milestones through the utilization and development of project management tools, processes and standards; developing risk analysis, implementation and contingency plans at the project level; influencing operational best practices across the PE department; building and maintaining effective relationships with the PE team as well as partners involved in PE studies & other projects; effectively managing upward and cross-functional communications; and ensuring documentation of key team information and decisions. The PEPM will work with Subject Matter Experts (SMEs) within GPS and non-GPS functions on department projects as appropriate.

Primary Responsibilities:

1. Strategic Leadership & Portfolio Oversight

• Lead the planning, execution, and delivery of a diverse portfolio of PE studies.
• Provide strategic input on epidemiologic study design, feasibility, analytic approaches, and data source selection.
• Ensure alignment of study strategy with regulatory requirements, product safety needs, and business objectives.
• Understand the PE study commitments across a molecule to ensure solutions meet the needs of the molecule by delivering a committed trial.
• Collaborate with the PE scientist to align on the operational strategy to successfully implement the trial strategy.
• Partners with Regulatory and PE scientists/leadership on PMR/PMC dates to ensure dates are achievable. This includes an evaluation of like trials ran by PE historically to assess ability to meet timelines prior to regulatory commitment.
• Partners with the PE scientists, GPS Medical Leadership to ensure the Trial strategy, Molecule Strategy and Cross-Molecule Strategy meets the needs of the organization with a focus on cost, time and resource management to ensure on time or early delivery that meets or regulatory obligations