Clinical Trial Program Lead

Eli Lilly and Company
  • Indianapolis, IN
    11 days ago

    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.

    Job title: Clinical Trial Program Lead

    Location:

    • UK: Bracknell (3/2 hybrid) OR
    • US: Indianapolis Corporate Center

    Reports to: Executive Director-Exploratory Medicine and Pharmacology- Portfolio Delivery

    ABOUT LILLY:

    Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

    ROLE PURPOSE AND OVERVIEW:

    The purpose of the Clinical Delivery Program Lead is to lead the creation and execution of the exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan.

    As the Clinical Delivery Program Lead you will be responsible for planning and delivering exploratory and biopharmaceutics clinical molecules and submissions milestones on time and on budget throughout the molecule lifecycle. Additionally, taking responsibility for all aspects of global clinical trial operations within the plan, as the single operational point of contact from trial design through execution and close out, including timeline creation and management, outsourcing plan, vendor management (including direct oversight of the operational deliverables), patient recruitment and retention and budget management.

    You may also be assigned additional trial level management support from internal or external resources.

    MAIN RESPONSIBILITIES INCLUDE:

    Scientific and Therapeutic Area Expertise

    • Lead Phase 1 clinical asset strategy using quality decision-making.
    • Deep understanding of therapeutic area, trial design, risks, and best practices.
    • Advise on clinical and regulatory documents (e.g., protocols, IBs, NDAs, CSRs).
    • Stay current on disease knowledge, competitors, and industry trends.
    • Understand operational needs for early-phase studies and submissions.

    Clinical Project Management

    • Lead clinical project management processes and tools.
    • Collaborate with TPOs to execute clinical strategy and oversee trial outcomes.
    • Maintain clinical timelines and communicate progress to stakeholders.
    • Manage clinical budgets and change processes with cross-functional teams.
    • Identify and communicate clinical risks and mitigation plans.

    Clinical Operations

    • Oversee clinical trial operations to meet timelines and budgets.
    • Lead trial planning and execution activities.
    • Select and manage vendors to ensure quality and timely delivery.
    • Act as main contact for global clinical team, resolving issues and managing risks.
    • Partner with regulatory and medical teams on safety processes.

    Communication and Team Management

    • Promote quality mindset and document key decisions and metrics.
    • Lead clinical team interactions and governance participation.
    • Communicate clearly across all levels to support decision-making.

    Leadership

    • Collaborate across levels and functions; deliver through others.
    • Navigate ambiguity with strong problem-solving and strategic thinking.
    • Influence and negotiate effectively in a matrix environment.
    • Foster learning, critical thinking, and innovation.
    • Mentor and provide constructive feedback to colleagues.

    ESSENTIAL REQUIREMENTS:

    • Bachelor's degree in a science related field
    • Few years of experience in the pharmaceutical industry managing clinical studies
    • Few years of experience managing Phase 1 studies including exploratory and biopharmaceutics clinical development.
    • Vendor and contract management
    • Proficient in end-user computing and Microsoft Office (Word, Excel, PowerPoint, Project)
    • Strong knowledge of clinical trial regulations and guidelines
    • Skilled in managing TPOs to ensure trial deliverables
    • Experienced with project management tools and methodologies
    • Willing to travel up to 10%

    YOU WILL SUCCEED IN THIS ROLE IF:

    You thrive in mentoring and developing others, excel in cross-cultural and virtual team environments, and bring strong leadership and networking capabilities. Your ability to solve problems through root cause analysis, manage your time effectively, and adapt to diverse settings and stakeholders will be key. Clear and confident communication, both written and verbal, along with the ability to influence and build strong relationships across internal and external teams, will set you apart.

    EMBRACING DIVERSITY:

    Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines.

    For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.

    #LI-LD2

    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.

    #WeAreLillyUKandIreland

    Numbers & Facts

    LocationIndianapolis, IN

    Skills

    • Best Practicesunmatched
    • Biotech and Pharmaceuticalunmatched
    • Budget Managementunmatched
    • Budgetingunmatched
    • Clinical Adviceunmatched
    • Clinical Practices/Protocolsunmatched
    • Clinical Researchunmatched
    • Clinical Study Publicationsunmatched
    • Clinical Trialunmatched
    • Clinical Trial Managementunmatched
    • Communication Skillsunmatched
    • Community Supportunmatched
    • Cross-Functionalunmatched
    • Decision Supportunmatched
    • Disease Prevention and Controlunmatched
    • Diversityunmatched
    • Drug Developmentunmatched
    • Employee Retentionunmatched
    • International Healthunmatched
    • Leadershipunmatched
    • Medical Productsunmatched
    • Medicineunmatched
    • Mentoringunmatched
    • Microsoft Excelunmatched
    • Microsoft Officeunmatched
    • Microsoft PowerPointunmatched
    • Microsoft Wordunmatched
    • Needs Assessmentunmatched
    • Negotiation Skillsunmatched
    • New Drug Applicationunmatched
    • Operations Planningunmatched
    • Outsourcingunmatched
    • Pharmacologyunmatched
    • Problem Solving Skillsunmatched
    • Project Management Softwareunmatched
    • Regulationsunmatched
    • Risk Managementunmatched
    • Root Cause Analysisunmatched
    • Safety Processunmatched
    • Team Lead/Managerunmatched
    • Technical Leadershipunmatched
    • Time Managementunmatched
    • Vendor/Supplier Managementunmatched
    • Vendor/Supplier Planningunmatched
    • Vendor/Supplier Selectionunmatched
    • Volunteer Experienceunmatched
    • Willing to Travelunmatched

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