Global Clinical Program Lead

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

About Roche Culture

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

The Opportunity

• As a Clinical Program Lead within the Clinical Development and Medical Affairs (CDMA) chapter, you will provide high-level strategic leadership and scientific rigor for global evidence generation programs. You act as the primary strategic architect between Life Cycle Teams (LCT) and clinical execution, ensuring diagnostic solutions are backed by robust data to improve patient outcomes. Operating in a matrixed global environment, you will drive the development of Integrated Evidence Generation Plans (IEGP) and oversee complex clinical trials from inception through regulatory success.
• Drive the planning, development, and delivery of global evidence generation programs, maintaining full accountability for program progress, budgets, timelines, and strategic risk management.
• Architect and lead the development of Integrated Evidence Generation Plans (IEGP) for assigned products in close partnership with internal and external stakeholders.
• Serve as a strategic partner and primary interface between CDMA and Life Cycle Teams (LCTs), aligning clinical evidence generation with broader business strategies.
• Partner with Functional Partners and Sub-Chapter Leads to define resource requirements and coordinate capacity across CDMA Networks and Project Teams.
• Oversee program-level budgets and trial timelines, performing proactive scenario assessments to mitigate operational and regulatory risks.
• Ensure proactive alignment across Regulatory Affairs, R&D, Diagnostics Partners, and cross-functional CDMA chapters to ensure seamless trial execution.
• Champion a patient- and customer-centric mindset while fostering an inclusive, collaborative environment across global matrixed teams.

Who you are (Required)

• Bachelor's degree in a scientific discipline or related field (Advanced degree preferred).
• 8+ years of project or clinical trial coordination/management experience 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).

Preferred

• Advanced degree (Master's, Ph.D., or PharmD) in a life sciences or clinical research discipline.
• Project Management Professional (PMP) or equivalent project management certification.
• Prior experience managing clinical programs bridging IVD (In Vitro Diagnostics) or companion diagnostics with therapeutic development.

Location

No relocation benefits are available for this posting. Local candidates are preferred, but remote work may be considered based on the candidate's experience and location.

Travel Requirements

Travel: Ability to travel approximately 20% (Domestic and International).

Salary

The expected salary range for this position based on the primary location of Tucson, AZ is $111,200 - $206,400 Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

• Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Tucson. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that m