Strategic Global Clinical Programs Leader

Roche; United States; On-site; USD 111,000 - 206,000; Full time

Job summary

Roche is seeking a Clinical Program Lead to provide strategic leadership for global evidence generation programs, guiding cross-functional teams and ensuring robust data to support regulatory success. You will architect Integrated Evidence Generation Plans and manage complex trials from inception through regulatory milestones.

The role requires 8+ years in clinical trial management, deep regulatory knowledge (ICH-GCP, ISO, GMP, GLP), and proven ability to navigate a matrixed global organization.

Qualifications

• Bachelor's degree in a scientific discipline (Advanced degree preferred).
• 8+ years of project or clinical trial coordination/management within a regulated CRO, diagnostic, or pharmaceutical environment.
• Proven track record managing clinical trial execution, bio-sample testing/management, and quality assurance processes under strict timelines.
• Demonstrated ability to lead by influence and drive consensus within a heavily matrixed, multi-site global organization.
• Deep mastery of international regulatory standards (ICH-GCP, ISO, GMP, GLP) and diagnostic/medical testing environments (FDA, CAP, CLIA, WHO).

Responsibilities

• Provide high-level strategic leadership and scientific rigor for global evidence generation programs.
• Drive planning, development, and delivery of global evidence generation programs including budgets and timelines.
• Architect and lead Integrated Evidence Generation Plans (IEGP) for assigned products.
• Serve as strategic partner between CDMA and Life Cycle Teams (LCTs) to align clinical evidence with broader strategies.
• Define resource requirements and coordinate capacity across CDMA Networks and Project Teams.
• Oversee program budgets and trial timelines, assess risks and mitigate issues.
• Ensure alignment across Regulatory Affairs, R&D, Diagnostics Partners, and cross-functional CDMA chapters.
• Champion patient- and customer-centric mindset within global matrixed teams.

Skills

Clinical trial management

Regulatory compliance

Cross-functional leadership

Budget management

Risk management

Leadership by influence

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Roche is seeking a Clinical Program Lead to provide strategic leadership for global evidence generation programs, guiding cross-functional teams and ensuring robust data to support regulatory success. You will architect Integrated Evidence Generation Plans and manage complex trials from inception through regulatory milestones.

The role requires 8+ years in clinical trial management, deep regulatory knowledge (ICH-GCP, ISO, GMP, GLP), and proven ability to navigate a matrixed global organization.