Clinical Trial Program Lead

Role Summary

The Clinical Trial Program Lead will lead 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 within the development plan. Location: UK Bracknell (3/2 hybrid) or US Indianapolis Corporate Center. You will plan and deliver exploratory and biopharmaceutics milestones on time and on budget throughout the molecule lifecycle, and serve as the single operational contact for global trial design through close out, including timeline creation and management, outsourcing plans, vendor management, patient recruitment and retention, and budget management. Additional trial level management support may be assigned from internal or external resources.

Responsibilities

• 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.
• 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.
• 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.

Qualifications

• 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

Skills

• Mentoring and developing others
• Strong leadership and networking capabilities
• Problem solving through root cause analysis
• Time management
• Adaptability to diverse settings and stakeholders
• Clear and confident communication, written and verbal
• Ability to influence and build relationships across internal and external teams

Additional Requirements

• Travel: Willing to travel up to 10%