Clinical Program Leader

Roche•Tucson, AZ

11d•Remote

About The Position

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 Clinical Program Leader (CDMA) Therapeutic Area: Clinical Development & Medical Affairs (CDMA) The Opportunity 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. "This is a remote based role"

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

Responsibilities

Proactively align clinical execution strategies with Life Cycle Teams (LCT), Project Teams (PT), and CDMA medical/clinical goals.
Lead the end-to-end planning and delivery of evidence generation programs (registrational and non-registrational) with full accountability for progress, budgets, and timelines.
Partner with Regulatory Affairs, R&D, Diagnostics Partners, and CDMA chapters to drive proactive risk management and strategic scenario assessments.
Serve as the key strategic partner for LCTs, providing subject matter expertise to coordinate capacity, priority, and budgets within the chapter.
Drive the creation of the Integrated Evidence Generation Plan in collaboration with internal stakeholders and external Key Opinion Leaders (KOLs).
Accountable for program-level budgets and ensuring adequate resource allocation by communicating demands and skillset requirements to Sub-Chapter Leads.
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).