Associate Director/Director, Pharmacoepidemiology Project Manager

527 Eli Lilly Cork Limited; Cork; Hybrid; EUR 72,000 - 106,000; Full time

Benefits offered by this job

Pension plan

Vacation benefits

Healthcare benefits

Flexible benefits

Life insurance

Time off and leave benefits

Well-being benefits

Job summary

Eli Lilly Cork Limited is seeking a Clinical Development Project Manager (PEPM), Associate Director/Director, to lead cross-functional teams in complex pharmacoepidemiology studies and global trial execution.

You will drive planning, risk management, and budget oversight while coordinating with regulatory and scientific leadership to meet milestones and ensure quality outcomes.

Qualifications

• Bachelor's degree in a scientific or health-related field; 5+ years in clinical research.
• Advanced degree welcomed; proven cross-functional leadership in trials.
• Experience with pharma/clinical trial governance and PMO activities.

Responsibilities

• Lead planning, execution and delivery of diverse pharmacoepidemiology studies.
• Provide strategic input on study design, feasibility, and data source selection.
• Manage budgets, timelines and risks across global trials.
• Coordinate cross-functional teams and external partners to meet milestones.
• Ensure regulatory alignment and inspection readiness for trials.

Skills

Project management

Cross-functional collaboration

Stakeholder communication

Risk management

Leadership

Education

Bachelor's degree in scientific/health-related field

Advanced degree

Tools

Veeva

MS Project

MS Excel

PowerBI

Critical Chain tooling

Job description

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.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

Overview

The Clinical Development Project Manager (PEPM), Associate Director/Director independently leads the cross‑functional study team in the development and execution of complex clinical trials 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.

Primary Responsibilities

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. The primary purpose of the GPS PEPM is to support the planning, contracting, execution and tracking of complex pharmacoepidemiology 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 pharmacoepidemiology department; building and maintaining effective relationships with the pharmacoepidemiology team as well as partners involved in pharmacoepidemiology 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.

Strategic Leadership and 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, building and operations 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 a committed trial. Lead the monthly PE study review with KPI’s and metrics. Collaborate with the Pharmacoepidemiology 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. Partners with the Pharmacoepidemiology 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 regulatory obligations with minimal protocol amendments.

Lead weekly team reviews of studies to address risks, issues, vendor noncompliance and overall pharmacoepi 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.

Project Management, and 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. Drive to solutions across the molecule/program. Be accountable for trial/regional/program/molecule enrollment strategy and execution from country allocation through Last Patient enrolled. Partner with the Regional Operations to achieve regional enrollment goals. Foster relationships and serve as a single point of contact and central owner for trial communication, to and from the CDDA Organization, Regional Clinical Operations, and Third‑Party Organizations (TPOs). Effectively manage and influence upward. Anticipate and resolve complex and key technical operational or business problems with cross‑functional study team (including vendors, affiliates/regions, global team members, and other business partners) with little/ no need for direct management support. Evaluate and determine issues that require escalation. Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc. Leverage expertise to make timely decisions for ambiguous and complex situations. Uphold a consistent, solution‑oriented approach to conducting daily business. Demonstrate credibility and influence to enable teams and multiple business partners, both internally and externally, to make effective and timely decisions.

Scientific Expertise

Leverage and demonstrate broad understanding of therapeutic, clinical drug development, and process expertise in order to influence study design and program‑level decisions considering regional needs. Recognize inter‑relatedness of cross‑functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise across functional teams, regions, and external partners and make decisions on process and issues affecting study implementation and execution. Be knowledgeable on the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams. Single point of accountability for the Trial Master File for assigned trials, working closely with functional record owners to ensure the file is always current and inspection ready. Ensure inspection readiness of respective clinical trial(s). Ensures timely documentation of deviations, creation of story boards or issue summary documents (e.g. for high‑risk areas/hot topics) and coaches PEPMs in these activities. Network and leverage expertise to anticipate trial and regional issues, identify areas of process breakdown, analyze situations and propose innovative approaches that positively impact ability to deliver the clinical trial while reducing and/or mitigating risks. Share process learnings to benefit the Lilly portfolio. Contribute to the development of others by acting as a coach for peers as well as new PEPMs, cross‑functional team members and TPOs on aspects of CT process and regional specificities. Maximize shared learning opportunities within their clinical team, capitalizing on best practices. Identify and lead process improvement activities. Acts as a PEPM SME resource to peers and in the development and rollout of new tools, processes or methodologies to proceed as quickly as science allows. Lead decisively during ambiguity. Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools. Be instrumental in driving regional clinical operational processes and methodologies used. Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical trials. Liaise with affiliates and other appropriate resources to understand local regulatory requirements. Independently detect and resolve quality issues, escalating to functional leadership or consulting other functions (e.g., Medical Quality, Legal, Compliance, etc.) to arrive at the best solution.

Minimum Qualification Requirements

• Bachelors or University degree (scientific or health‑related field preferred) and 5 years clinical research experience or relevant experience in a scientific or health‑related field
• or an advanced degree

Highly Desired Skills

• Applied knowledge of project management methodology, processes and tools
• Demonstrated ability to lead and work effectively cross‑culturally with global colleagues and with TPOs
• Be recognized as a leader with demonstrated ability to coach others in process expertise
• Embrace strategic organizational changes and lead others effectively through these, exhibiting flexibility to adjust quickly and effectively to frequent change and altered priorities
• Ability to influence without authority
• Previous experience working in cross‑functional teams/ projects and/or ability to establish and manage relationships
• Effective and influential communication, self‑management, and organizational skills
• Demonstrated ability to manage complex situations through problem‑solving, critical thinking and navigating ambiguity

Other Information/Additional Preferences

• Minimum of 6 years clinical trial experience with a strong working knowledge of the clinical research process
• Prior clinical trial site‑level or affiliate experience
• Prior experience with local/country regional requirements
• Strong analytical skills
• Proficiency in use of project management tools and techniques (e.g., Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI)
• Need to travel periodically to AST/ ISST and potentially other scientific/ regional meetings

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.

The anticipated wage for this position is €72,300 - €106,040 Full‑time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance).

• including eligibility to participate in a pension plan
• vacation benefits
• eligibility for healthcare benefits
• flexible benefits (if applicable) life insurance and death benefits
• certain time off and leave of absence benefits
• well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLillyUKandIreland At Lilly we strive to ensure our employees are part of a group 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!