Associate Director Clinical Development Trial Lead

BlueSteps Connect; United States; On-site; USD 150,000 - 230,000; Full time

Job summary

BlueSteps Connect in the United States is seeking an experienced Associate Director, Clinical Development Trial Lead to drive execution of complex global oncology clinical trials, overseeing study strategy, enrollment, budgets, CRO partnerships, and cross-functional teams.

This highly visible leadership role will influence clinical development decisions on a global scale, ensure on-time delivery within scope and budget, and maintain inspection readiness with Trial Master File accountability.

Qualifications

• Experience leading cross-functional study teams.
• Proven ability to manage study strategy and enrollment.
• Knowledge of oncology drug development.
• Experience with budgets and CRO partnerships.

Responsibilities

• Independently lead cross-functional study teams to develop and execute complex clinical trials.
• Ensure delivery of milestones on time, within scope and budget.
• Influence study design and program-level decisions considering regional needs.
• Coordinate regional input for study teams and manage Trial Master File accountability.
• Travel periodically to scientific and regional meetings to drive regional processes.

Skills

Cross-functional leadership

Clinical trial execution

Budget management

CRO partnerships

Job description

the client is seeking an experienced Associate Director, Clinical Development Trial Lead to drive the execution of complex global oncology clinical trials. This highly visible leadership role will oversee study strategy, enrollment, budgets, CRO partnerships, and cross-functional teams, and will influence clinical development decisions on a global scale.

Responsibilities include independently leading cross-functional study teams to develop and execute complex clinical trials and ensure delivery of clinical milestones with quality, on time, and within scope and budget. The role will demonstrate independent leadership and proactive issue identification and resolution, apply broad therapeutic and clinical drug development/process expertise to influence study design and program-level decisions while considering regional needs, and coordinate the capture of regional input for study teams.

The Associate Director, Clinical Development Trial Lead will serve as a single point of accountability for the Trial Master File for assigned trials, working closely with functional record owners to ensure it remains current and inspection ready. They will ensure inspection readiness by managing timely documentation of deviations and creation of summary materials for high-risk areas, report and interpret clinical trial information for completeness and accuracy across systems and tools, and drive regional clinical operational processes and methodologies, including periodic travel to scientific and regional meetings.