Clinical Program Leader

Roche

21h

About The Position

As a Clinical Program Lead within the Clinical Development and Medical Affairs (CDMA) chapter, you 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 as a senior leader in a matrixed environment, you drive the development of Integrated Evidence Generation Plans (IEGP) and oversee the delivery of complex global clinical trials from inception through to regulatory success.

Requirements

Bachelor’s degree in a scientific discipline or related field (Advanced degree preferred).
10+ years of progressive experience in clinical trials within the Diagnostics, Biotech, or Pharmaceutical industries.
Proven ability to lead by influence in a heavily matrixed, multi-site global organization; experience interacting with executive management.
Deep knowledge of international standards (ICH-GCP, ISO, GMP, GLP) and medical testing environments (FDA, CAP, CLIA, WHO).
Highly autonomous with the ability to initiate change, manage complex multi-million dollar budgets, and drive results through external resources.

Responsibilities

Plan and execute registrational and research clinical trial programs (US and OUS) in compliance with Design Control requirements.
Provide technical expertise for the development of core trial documents (protocols, monitoring plans, CSRs) and overall trial conduct.
Foster strong, collaborative relationships with cross-functional leaders and alliance partners to ensure operational excellence.
Represent the department at SPC (Solution Portfolio Committee) and CA LT (Customer Areas Leadership Teams) to align strategic decisions.
Ensure all activities adhere to international regulations (FDA, CE-Mark, IVD) and departmental Standard Operating Procedures (SOPs).