Associate Director/Director, Pharmacoepidemiology Project Manager

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 Yourself!

Purpose:

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. 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.

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.

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, 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. This includes an evaluation of like trials run by PE historically to assess ability to meet timelines prior to regulatory commitment.
• 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 or regulatory obligations with minimal protocol amendments. Leads 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:
• o 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.
• o 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)
• o 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.
• o 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.
• o 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.
• Manage TPO (third party organization) qualification process, selection, and oversight.
• Serve as the CRO (Clinical Research Organization) point of contact for outsourced and fully outsourced trial execution.
• Ensure CRO delivery of project milestones.

Clinical Trial Process Leadership and 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.

Scientific Expertise

• Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.
• Combine scientific regional, operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.
• Leverage clinical development 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 their clinical team.

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 () 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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