Clinical Program Leader

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Therapeutic Area: Clinical Development & Medical Affairs (CDMA)

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.

• Strategic Leadership: Proactively align clinical execution strategies with Life Cycle Teams (LCT), Project Teams (PT), and CDMA medical/clinical goals.

• Evidence Generation: Lead the end-to-end planning and delivery of evidence generation programs (registrational and non-registrational) with full accountability for progress, budgets, and timelines.

• Matrix Influence: Partner with Regulatory Affairs, R&D, Diagnostics Partners, and CDMA chapters to drive proactive risk management and strategic scenario assessments.

• Functional Partnership: Serve as the key strategic partner for LCTs, providing subject matter expertise to coordinate capacity, priority, and budgets within the chapter.

• Integrated Planning: Drive the creation of the Integrated Evidence Generation Plan in collaboration with internal stakeholders and external Key Opinion Leaders (KOLs).

• Resource & Financial Oversight: 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).

• Education: Bachelor's degree in a scientific discipline or related field (Advanced degree preferred).

• Experience: 10+ years of progressive experience in clinical trials within the Diagnostics, Biotech, or Pharmaceutical industries.

• Senior Leadership: Proven ability to lead by influence in a heavily matrixed, multi-site global organization; experience interacting with executive management.

• Regulatory Mastery: Deep knowledge of international standards (ICH-GCP, ISO, GMP, GLP) and medical testing environments (FDA, CAP, CLIA, WHO).

• Strategic Agility: Highly autonomous with the ability to initiate change, manage complex multi-million dollar budgets, and drive results through external resources.

Locations: Tucson, AZ | Penzberg, Germany | UK

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

Tucson, AZ Salary Range: $127,500.00 - $236,700.00 USD Annual Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law.

Roche Benefits Include:

• Discretionary Annual Bonus based on performance.

• Roche Long Term Incentive Plan (LTIP).

• Comprehensive Medical, Dental, and Vision insurance.

• 401(k) with company matching and paid time off.

Global Grade: SE8

Please note that the global grade displayed is a target global grade for the role and the actual global grade offered to a candidate may vary depending on several factors - including scope and breadth of the role. For further information relating to global grading in Roche please visit the global grading gSite.

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Roche is an equal opportunity employer.

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 make a global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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