Clinical Trial Program Lead

About the role

The Clinical Delivery Program Lead at Lilly is responsible for leading the creation and execution of exploratory and biopharmaceutics clinical development plans at a molecule level. This role involves technical leadership and operational oversight of clinical research trials within the development plan. Key responsibilities include scientific expertise, clinical project management, clinical operations, communication, and team management.

Responsibilities

• Lead phase 1 clinical asset strategy using quality decision-making.
• Deeply understand 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.
• 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.
• Oversee clinical trial operations to meet timelines and budgets.
• 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.
• 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.
• 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.

Requirements

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