Associate Director/Director 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), Associate Director/Director independently leads the cross-functional study team in the development and execution of complex pharmacoepidemiology (PE) studies and is accountable both regionally and globally to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget. The PEPM Associate Director/Director consistently demonstrates independent leadership, influence when working with study teams, management, and business partners, and prospective identification of potential issues and resolution thereof.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 observational 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. Lead across all studies and bring connectivity to themes, risks, resource management, and vendor oversight. Provide strategic input on epidemiologic study design, feasibility, analytic approaches, and data source selection. Be a team resource for good design, building and operations reviews for feasibility. 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. Lead the monthly PE study review with KPI's and metrics. Collaborate with the PE scientist to align on the operational strategy to successfully implement the trial strategy. Create a shared learning environment that carries lessons learned back to the team. Partners with Regulatory and PE scientists/leadership on PMR/PMC dates to ensure dates are achievable. This includes an evaluation of like trials run 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 with minimal protocol amendments. Leads weekly team reviews of studies to address risks, issues, vendor noncompliance and overall PE book of work. Manages the Study Management team meetings and ensure aligned communication across functions and stakeholders. Assess the needs for master protocols vs. Individual trial protocols based on the similarity of trials at the molecule level as well as across molecules to ensure strategic delivery is achieved and optimized. Be a consultant to support reviews and learnings across protocols. Makes recommendations to PMO leadership on CRO synergies, CRO delivery escalations, that limit internal resource needs and leverages CRO capabilities. Ensures data accuracy across tracking systems for studies to ensure accuracy at the portfolio level. Promote a culture of scientific integrity, transparency, and operational excellence.2. Project Management & Regional Operational Knowledge Broader responsibilities at Therapeutic Area/ Molecule/Indication level (e.g. attending relative Critical Chain network builds, providing input on strategy). Use project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials (CT) as described: + Scope - Understand the scope of work required to complete the successfully. Monitor the status and make adjustments and changes (per change control process) as needed to meet the deliverables of the trial. + Timeline - Develop and track global pharmacoepidemiology trial alignment and integrating inputs across functions and geographies. Provide consultation and guidance to PE scientists on their Integrated Plans. Enter key milestones into the dedicated tracking system (i.e., Pangea, Prism, Veeva Clinical) + Risk - Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan. + Budget - Understand the cross-functional, trial-level budget components. Create and monitor the budget grants and non-grants, and assumptions using financial tracking tools. Routinely network with appropriate business partners on trial-level budget status and changes. Function as point of contact for other PEPMs on their team as needed regarding budget items. Lead, influence and project manage large, complex studies and/or multiple smaller studies. Partner with other organizations to coordinate and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs) as required. Independently drive and influence local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including proactive issue management, contingency planning and issue resolution.