The Position

Who We Are
At Roche Diagnostics Solutions (RDS), our mission is clear: to diagnose earlier, develop faster, and personalize treatment because every patient is unique. Our Clinical Development & Medical Affairs (CDMA) team drives innovation to improve healthcare outcomes globally.

We see ourselves and our customers as a team that can only reach its full potential together. By listening closely to patients and physicians, and leveraging digitalization and new technologies, we get closer to their real-world needs. This collaborative spirit creates an environment where ideas can grow and new ways of doing things can be tried - resulting in competitive products that get to patients faster.

Our work spans the entire product lifecycle, from discovery to post-launch. By collaborating with internal teams, external partners, and patients, the CDMA chapter provides crucial medical insights, designs and executes clinical studies, and offers on-market support. Ultimately, we generate comprehensive clinical evidence that demonstrates product safety, effectiveness, and scientific validity - facilitating smooth product registration, adoption and reimbursement globally so we can save lives and improve patient quality of life.

The Opportunity
In this role, you will be the driving force behind the design and execution of our global clinical studies. As a Global Study Lead, you ensure that scientific innovation reaches patients through meticulously planned and high-quality clinical evidence generation.

• Lead with Impact: Direct global study teams with full accountability for study deliverables, ensuring quality, budget, and timelines are met with excellence.
• Shape Evidence Strategy: Collaborate with cross-functional partners to develop innovative evidence-generation scenarios, including real-world evidence and global clinical strategies.
• Master Study Design: Develop high-quality study protocols, validation plans, and essential documentation to guide the successful delivery of clinical research.
• Drive Collaboration: Build and maintain strong relationships with internal experts, Pharma partners, and international investigators to bring external know-how into our innovation process.
• Oversee Operational Excellence: Provide strategic oversight for outsourced activities, including CRO management and consultant relationships, to ensure seamless study execution.
• Ensure Readiness: Champion compliance with global standards (such as ICH-GCP) and ensure audit and inspection readiness at every stage of the study lifecycle.

Who You Are
You are a strategic thinker and a collaborative leader who thrives in a fast-paced, matrixed environment. You are passionate about putting patients first and are committed to maintaining the highest standards of integrity in clinical research.

• Experienced Leader: You bring established experience in Clinical Operations or Product Development within the Healthcare industry, with a proven track record of leading complex projects.
• Academic Foundation: You hold a Bachelor's degree in Life Sciences or a related field (an advanced degree is a plus).
• Strategic Partner: You are skilled at building consensus, negotiating with stakeholders, and explaining complex information to diverse audiences.
• Agile Problem Solver: You take a new perspective on existing solutions, solve complex problems with analytical thought, and adapt quickly to changing priorities.
• Compliance Minded: You have a solid understanding of international standards and regulations (e.g., IVDR, MDR, FDA) and their application in clinical studies.
• Cultural Champion: You value diversity and inclusion, working effectively across different cultures and time zones to create an environment where everyone belongs.

Roche is an Equal Opportunity Employer.