Clinical Trial Program 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.

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.

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.