Clinical Trial Program Lead

Lilly•Indianapolis, IN

5d•Hybrid

About The Position

The Clinical Trial Program Lead leads the creation and execution of exploratory and biopharmaceutics clinical development plans at the molecule level, providing technical leadership and operational oversight of clinical research trials. The role is responsible for delivering clinical milestones and submissions on time and within budget throughout the molecule lifecycle. The position owns global clinical trial operations across the plan as the single operational point of contact from trial design through execution and closeout. This includes creating and managing timelines, planning outsourcing, managing vendors and their operational deliverables, overseeing patient recruitment and retention, and managing budgets. Additional trial-level management support may be assigned from internal or external resources. The role requires scientific and therapeutic-area expertise, clinical project and operations leadership, clear communication across functions and levels, and the ability to influence and deliver through others in a matrix environment. The position is based in Bracknell, UK, with a 3/2 hybrid arrangement, or at the Indianapolis Corporate Center in the US.

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 experience.
Proficiency with end-user computing and Microsoft Office, including Word, Excel, PowerPoint, and Project.
Strong knowledge of clinical trial regulations and guidelines.
Skill in managing TPOs to ensure trial deliverables.
Experience with project management tools and methodologies.
Willingness to travel up to 10%.
Ability to mentor and develop others and work in cross-cultural and virtual team environments.
Strong leadership and networking capabilities.
Ability to solve problems through root cause analysis, manage time effectively, and adapt to diverse settings and stakeholders.
Clear and confident written and verbal communication skills, with the ability to influence and build relationships across internal and external teams.

Responsibilities

Lead Phase 1 clinical asset strategy and make quality decisions.
Apply knowledge of the therapeutic area, trial design, risks, and best practices.
Advise on clinical and regulatory documents, including protocols, investigator brochures, NDAs, and clinical study reports.
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.
Lead trial planning and execution activities.
Select and manage vendors to ensure quality and timely delivery.
Serve as the main contact for the global clinical team, resolving issues and managing risks.
Partner with regulatory and medical teams on safety processes.
Promote a quality mindset and document key decisions and metrics.
Lead clinical team interactions and participate in governance.
Communicate clearly across all levels to support decision-making.
Collaborate across levels and functions and deliver through others.
Navigate ambiguity using problem-solving and strategic thinking.
Influence and negotiate effectively in a matrix environment.
Foster learning, critical thinking, and innovation.
Mentor colleagues and provide constructive feedback.
Manage patient recruitment and retention, outsourcing plans, vendor deliverables, and trial budgets across the molecule lifecycle.