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
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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.
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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.
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Ensure alignment of study strategy with regulatory requirements, product safety needs, and business objectives.
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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.
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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.
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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.
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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.
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Manage the study management team meetings and ensure aligned communication across functions and stakeholders.
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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.
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Make recommendations to PMO leadership on CRO synergies and CRO delivery escalations that limit internal resource needs and leverage CRO capabilities.
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Ensure data accuracy across tracking systems for studies to ensure accuracy at the portfolio level.
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Promote a culture of scientific integrity, transparency, and operational excellence.
2.
Project Management & Study Delivery
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Hold broader responsibilities at therapeutic area, molecule and indication level (e.g. attending relevant network builds and providing input on strategy).
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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.
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Lead, influence and project manage large, complex studies and/or multiple smaller studies.
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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.
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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.
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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.
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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.
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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.
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Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, and new technology.
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Leverage expertise to make timely decisions in ambiguous and complex situations. Uphold a consistent, solution-oriented approach to conducting daily business.
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Demonstrate credibility and influence to enable teams and multiple business partners, both internally and externally, to make effective and timely decisions.
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Manage the TPO qualification process, selection, and oversight.
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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
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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.
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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.
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Be knowledgeable on the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams.
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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.
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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.
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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.
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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.
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Maximize shared learning opportunities within the team, capitalizing on best practices.
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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.
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Lead decisively during ambiguity.
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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.
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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.
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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.
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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.
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Combine scientific, regional and operational knowledge as well as process expertise to impact study design, feasibility and implementation.
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Leverage drug development and epidemiologic knowledge, problem solving and critical thinking skills to support the scientific needs of the business.
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Function as a point of contact for therapeutic area and/or disease state expertise for others on the team.
5.
Functional Leadership & People Management
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Lead, motivate and work with team members to provide them with appropriate objectives/personal development plans/career opportunities.
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Ensure optimal resource and workload management/prioritization.
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Collaborate with colleagues to ensure a coordinated and consistent approach to operational issues and staff management across teams, functions and sites.
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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.
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Coach and mentor direct reports (supervisors and talented employees) to build strong leadership and technical capabilities for the future organizational needs.
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Partner with global GPS partners for efficiency, quality improvements, and process/technology changes as required.
6.
Site & Enterprise Leadership
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Drive strong partnership and engage with Cork Site Leadership, RDMC and other functional groups to support site strategy and effectiveness
7.
Quality & Compliance Management
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Lead or contribute to business process improvement initiatives.
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Stay updated on the changing global regulatory environment and proactively adapt the organization’s policies and practices.
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Support internal and external inspections through resource coordination, document collection, trained personnel, and direct participation.
8.
Company Presence / Influence Outside of GPS PE Organization
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Represent Lilly in relevant external groups/initiatives, including scientific, regulatory, and pharmacovigilance forums.
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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.