Associate Director, Clinical Development Trial Lead (CDTL)

Role Summary

The Associate Director, Clinical Development Trial Lead (CDTL) independently leads the cross-functional study team in the development and execution of complex clinical trials and is accountable both regionally and globally to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget. The Associate Director, CDTL consistently demonstrates independent leadership, influence when working with study teams, management, and business partners, and prospective identification of issues and resolution thereof.

Responsibilities

• Lead, influence and project manage large, complex studies and/or multiple smaller studies; drive cross-functional study teams through study implementation, execution and closure.
• Develop and track global trial enrollment plans, integrate inputs across functions and geographies, and provide guidance to CDTLs on integrated plans; manage trial/regional enrollment strategy from country allocation through Last Patient Entered Treatment (LPET).
• Monitor scope, timeline, risk, and budget for clinical trials; adjust per change control; create and monitor budget status with cross-functional partners.
• Coordinate Investigator Study Specific Training (ISSTs) and Affiliate Study Training (ASTs); foster relationships with regional operations, vendors, affiliates/regions, and Third-Party Organizations (TPOs).
• Lead and influence local, regional and global cross-functional teams to meet deliverables, including proactive issue management, contingency planning, and issue resolution; escalate when needed.
• Ensure trial documentation readiness and quality, including Trial Master File accountability, deviations, and issue summaries; coach CDTLs in inspection readiness activities.
• Apply global/regional regulations, Good Clinical Practice (GCP), and Lilly standards; liaise with affiliates to understand local regulatory requirements.
• Manage Third-Party Organization qualification, selection, and oversight; serve as CRO clinical development point of contact for outsourced trial execution.
• Identify and lead process improvement activities; act as CDTL SME for peers and in development/rollout of new tools and methodologies.
• Anticipate and resolve complex operational or business problems with cross-functional teams; identify issues requiring escalation; drive solutions across the molecule/program.

Qualifications

• Required: Bachelor's degree (scientific or health-related field preferred).
• Required: 5+ years of clinical research experience or relevant experience in a scientific or health-related field.
• Required: legally authorized to be employed in the United States (sponsorship not anticipated).
• Preferred: Experience in oncology and radioligand therapy (RLT); applied knowledge of project management methodology, processes, and tools; demonstrated ability to lead cross-cultural teams and coach others in process expertise; ability to influence without authority; strong communication, self-management, and organizational skills; experience with cross-functional projects and relationship building; problem solving and navigating ambiguity.
• Other: Travel periodically to scientific/regional meetings as needed.

Skills

• Therapeutic area and disease-state expertise; ability to influence study design and program-level decisions with regional considerations.
• Strategic thinking with ability to manage ambiguity and drive timely decisions; strong analytical and problem-solving capabilities.
• Excellent coordination with global/regional teams, VPs, affiliates, vendors, and TPOs; strong communication and collaboration skills.

Additional Requirements

• Minimum of 5 years clinical trial experience with strong knowledge of the clinical research process; prior trial site-level or affiliate experience; familiarity with local/country/regional requirements.
• Proficiency with project management tools (e.g., MS Project, Excel, PowerPoint, PowerBI) and systems (e.g., Veeva).