Associate Director, Clinical Development Trial Lead (CDTL)

Role Summary

Associate Director, Clinical Development Trial Lead (CDTL) independently leads cross-functional study teams in the development and execution of complex clinical trials, accountable regionally and globally to deliver milestones with quality, on time, and within scope and budget.

Responsibilities

• Lead, influence, and project manage large, complex studies and/or multiple smaller studies.
• Develop and execute local, regional, and global clinical trials using project management skills, processes, and tools.
• Define and monitor scope, timelines, risks, and budget; adjust as needed per change control and financial tracking.
• Provide enrollment strategy and execution from country allocation through LPET; partner with Regional Operations to achieve regional enrollment goals.
• Serve as central owner for trial communication with the organization, regional clinical operations, and third-party organizations; manage expectations upward.
• Resolve complex operational or business problems with cross-functional teams and escalate issues as needed.
• Identify continuous improvement opportunities; coach peers and new CDTLs on CT processes and regional specifics.
• Ensure Trial Master File accuracy and inspection readiness; document deviations and prepare issue summaries.
• Apply global/regional regulations, GCP, and Lilly standards; liaise with affiliates to understand local regulatory requirements.
• Serve as CRO clinical development contact for outsourced trial execution; ensure CRO delivers project milestones.
• Lead process improvements and act as CDTL SME for tools, processes, or methodologies.

Qualifications

• Bachelor's degree (scientific or health-related field preferred).
• 5+ years clinical research experience or relevant experience in a scientific or health-related field.
• Legal authorization to work in the United States; sponsorship for visa status not anticipated.

Skills

• Experience with oncology and radioligand therapy (RLT) preferred.
• Applied knowledge of project management methodologies, processes, and tools.
• Strong cross-cultural leadership and ability to coach others in process expertise.
• Ability to influence without authority and manage relationships across global teams and TPOs.
• Excellent communication, self-management, and organizational skills; problem-solving and critical thinking to navigate ambiguity.
• Proficiency with project management tools (e.g., MS Project, Excel, PowerPoint, PowerBI) and related systems (e.g., Veeva).

Education

• As above in Qualifications.

Additional Requirements

• Travel periodically to scientific/regional meetings.