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-functional study team throughout study implementation, execution and closure, empowering them to meet the study deliverables, including proactive issue management, contingency planning and issue resolution. Drive to solutions across the molecule/program.
• Be accountable for study delivery from data source selection and country allocation through database lock and final study report, including the recruitment strategy and its execution where primary data collection applies.
• Foster relationships and serve as a single point of contact and central owner for study communication to and from GPS, regional and affiliate organizations, and Third-Party Organizations (TPOs). Effectively manage and influence upward.
• Anticipate and resolve complex and key technical, operational or business problems with the cross-functional study team (including vendors, affiliates/regions, global team members, and other business partners) with little or 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, and new technology.
• Leverage expertise to make timely decisions in 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.
• Manage the TPO qualification process, selection, and oversight.
• Serve as the CRO (Contract Research Organization) point of contact for outsourced and fully outsourced study execution. Ensure CRO delivery of project milestones.

3. Study Process Leadership & Expertise

• Leverage and demonstrate broad understanding of therapeutic, drug development, epidemiologic method and process expertise in order to influence study design and program-level decisions, considering data source and regional needs.
• Recognize the inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall study. Look for opportunities to expand and deepen study 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.
• Act as single point of accountability for the study master file for assigned studies, working closely with functional record owners to ensure the file is always current and inspection ready.
• Ensure inspection readiness of respective pharmacoepidemiology studies. Ensure timely documentation of deviations and creation of story boards or issue summary documents (e.g. for high-risk areas/hot topics), and coach PEPMs in these activities.
• Network and leverage expertise to anticipate study and regional issues, identify areas of process breakdown, analyze situations and propose innovative approaches that positively impact the ability to deliver the study 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 the PE study process and regional specificities.
• Maximize shared learning opportunities within the team, capitalizing on best practices.
• Identify and lead process improvement activities. Act as a PEPM subject matter expert resource to peers and in the development and rollout of new tools, processes or methodologies, to proceed as quickly as the science allows.
• Lead decisively during ambiguity.
• Report, manage and interpret information for assigned studies, including completeness and accuracy across multiple business systems and tools. Be instrumental in driving the operational processes and methodologies used.
• Apply expertise and knowledge of global and regional regulations, Good Pharmacovigilance Practices (GVP), Good Pharmacoepidemiology Practices (GPP) and Lilly standards of operation in the conduct of pharmacoepidemiology studies. Liaise with affiliates and other appropriate resources to understand local regulatory and data protection requirements.
• Independently detect and resolve quality issues, escalating to functional leadership or consulting other functions (e.g. Medical Quality, Legal, Compliance) to arrive at the best solution.

4. Scientific Expertise

• Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for scientific and regulatory documents, prepare for meetings with regulatory agencies, and draft responses to questions from regulatory agencies, TPOs and affiliates.
• Combine scientific, regional and operational knowledge as well as process expertise to impact study design, feasibility and implementation.
• Leverage drug development and epidemiologic knowledge, problem solving and critical thinking skills to support the scientific needs of the business.
• Function as a point of contact for therapeutic area and/or disease state expertise for others on the team.

5. Functional Leadership & People Management

• Lead, motivate and work with team members to provide them with appropriate objectives/personal development plans/career opportunities.
• Ensure optimal resource and workload management/prioritization.
• Collaborate with colleagues to ensure a coordinated and consistent approach to operational issues and staff management across teams, functions and sites.
• Recruit, develop, and retain a strategic and talented workforce with strong epidemiology expertise and pharmacovigilance skills to deliver high performance in their area of work and potential to learn and evolve for current and future needs of the organization.
• Coach and mentor direct reports (supervisors and talented employees) to build strong leadership and technical capabilities for the future organizational needs.
• Partner with global GPS partners for efficiency, quality improvements, and process/technology changes as required.

6. Site & Enterprise Leadership

• Drive strong partnership and engage with Cork Site Leadership, RDMC and other functional groups to support site strategy and effectiveness

7. Quality & Compliance Management

• Lead or contribute to business process improvement initiatives.
• Stay updated on the changing global regulatory environment and proactively adapt the organization’s policies and practices.
• Support internal and external inspections through resource coordination, document collection, trained personnel, and direct participation.

8. Company Presence / Influence Outside of GPS PE Organization

• Represent Lilly in relevant external groups/initiatives, including scientific, regulatory, and pharmacovigilance forums.
• Build effective relationships and collaborations that will facilitate external influence.

9. Understand the roles and responsibilities of the EU qualified person (QP) and support the fulfilment of the QP’s legal responsibilities when required.

Minimum Qualification Requirements:

• Master’s degree in a health-related field (preferably PhD in Epidemiology or related Public Health field) and 3+ years of experience in scientific research or the pharmaceutical industry; or a Bachelor’s/University degree in a scientific or health-related field and 5+ years of relevant clinical research, observational research or pharmacoepidemiology experience.
• Management or Supervisory experience (2 years or more) with demonstrated effective leadership and interpersonal skills.
• Applied knowledge of project management methodology, processes and tools, with demonstrated experience delivering complex studies or projects to time, cost and quality.
• Expertise in the design, conduct, analysis, interpretation, and communication of scientific research and/or observational studies.
• Ability to develop and implement strategies across people, processes, organizations, and technology based on data and sound judgment.
• Ability to work in a multicultural virtual global environment and partner across a matrix organization to collaborate with peers locally and globally.
• Strong ability to influence across boundaries, with strong business partner and customer focus.
• Strong communication skills, both verbal and written (in English).
• Availability to travel when required.

Highly Desired Skills:

• Demonstrated ability to lead and work effectively cross-culturally with global colleagues and with Third-Party Organizations.
• 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:

• Proficiency with standard desktop and pharmacovigilance computing programs including signal detection and data mining software, and databases (e.g. FDA AERS) supportive of drug safety research.
• Experience using longitudinal national databases, claims databases, or electronic medical records (e.g. CPRD) for epidemiologic research.
• Minimum of 6 years of study delivery experience with a strong working knowledge of the observational and/or clinical research process.
• Prior experience with local and country-level regulatory and data protection requirements.
• Strong analytical skills.
• Proficiency in the use of project management tools and techniques (e.g. Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, Power BI).
• Need to travel periodically to investigator/affiliate study training and potentially other scientific or regional meetings.
• Role to be located in the Republic of Ireland.

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). In addition, Lilly offers a comprehensive benefit program to eligible employees, 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; and 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.

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About Us

At Lilly we strive to ensure our employees are part of a team 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!

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