Associate Director/Director, Pharmacoepidemiology Project Manager (PEPM) & Team Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
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 Yourse!
Purpose
Pharmacoepidemiology Project Manager (PEPM), RDMC Cork, Global Patient Safety Pharmacoepidemiology (GPS PE) is to lead the planning, contracting, execution and tracking of complex pharmacoepidemiology studies through the application of project management discipline and expert knowledge of pharmacoepidemiology, and to provide personnel leadership to the GPS PE team based in Cork. The Associate Director/Director, in conjunction with the GPS PE Leadership Team, will optimize PE capacity in support of risk assessment and risk management activities for assigned Lilly products.
The role is accountable for the delivery of study milestones through the utilization and development of project management tools, processes and standards; for developing risk analysis, implementation and contingency plans at study and portfolio level; for influencing operational best practice across the pharmacoepidemiology department; for building and maintaining effective relationships with the pharmacoepidemiology team and with partners involved in pharmacoepidemiology studies and other projects; for effectively managing upward and cross-functional communications; and for ensuring documentation of key team information and decisions. The Associate Director/Director will work with Subject Matter Experts (SMEs) within GPS and non-GPS functions on department projects as appropriate.
The Associate Director/Director will also work in close collaboration with global leaders responsible for relevant function(s) and will ensure the GPS PE Team’s alignment to and integration with the global business needs and strategy. The Associate Director/Director will provide tactical direction to ensure the GPS PE team at Cork demonstrates strong technical capabilities, maintains a high level of compliance (to both internal and external global regulatory expectations) and continues to evolve and grow to meet the organizational needs and external environment.
Primary Responsibilities:
This job description is intended to provide a general overview of the job requirements at the time it was prepared.
1. Strategic Leadership & Portfolio Oversight
Lead the planning, execution, and delivery of a diverse portfolio of pharmacoepidemiology 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, and lead operational reviews for feasibility.
Ensure alignment of study strategy with regulatory requirements, product safety needs, and business objectives.
Understand the pharmacoepidemiology (PE) study commitments across a molecule to ensure solutions meet the needs of the molecule by delivering the committed study. Lead the monthly PE study review with KPIs and metrics.
Collaborate with the pharmacoepidemiology scientist to align on the operational strategy to successfully implement the study strategy. Create a shared learning environment that carries lessons learned back to the team.
Partner with Regulatory and PE scientists/leadership on PMR/PMC dates to ensure dates are achievable. This includes an evaluation of comparable studies run by PE historically to assess ability to meet timelines prior to regulatory commitment.
Partner with the pharmacoepidemiology scientists and GPS Medical Leadership to ensure the study strategy, molecule strategy and cross-molecule strategy meet the needs of the organization, with a focus on cost, time and resource management, to ensure on time or early delivery against regulatory obligations with minimal protocol amendments. Lead weekly team reviews of studies to address risks, issues, vendor non-compliance and the overall pharmacoepidemiology book of work.
Manage the study management team meetings and ensure aligned communication across functions and stakeholders.
Assess the need for master protocols versus individual study protocols based on the similarity of studies at the molecule level as well as across molecules, to ensure strategic delivery is achieved and optimized. Act as a consultant to support reviews and learnings across protocols.
Make recommendations to PMO leadership on CRO synergies and CRO delivery escalations that limit internal resource needs and leverage CRO capabilities.
Ensure 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 & Study Delivery
Hold broader responsibilities at therapeutic area, molecule and indication level (e.g. attending relevant network builds and providing input on strategy).
Use project management skills, processes, and tools to develop and execute local, regional and/or global pharmacoepidemiology studies as described:
Scope – Understand the scope of work required to complete the study successfully. Monitor the status and make adjustments and changes (per change control process) as needed to meet the deliverables of the study.
Timeline – Develop and track global pharmacoepidemiology study timelines, aligning and integrating inputs across functions and geographies. Provide consultation and guidance to PE scientists on their integrated plans. Enter key milestones into the
designated GPS tracking system.
Risk – Assess, identify and monitor study-level risks. Incorporate scientific knowledge, study process, data source and regional expertise to create one integrated study-level risk mitigation and contingency plan.
Budget – Understand the cross-functional, study-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 study-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.
Where a study involves primary data collection, partner with other organizations to coordinate and actively participate in investigator and affiliate study-specific training as required.
Independently drive and influence the local, regional and global cross-functiona