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Senior Director, Clinical Endpoint Adjudication Services
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Cytel
Pierre, SD (In Person)
Full-Time
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Job Description
The Senior Director, Clinical Endpoint Adjudication Services is a strategic and operational leader responsible for the delivery, quality, and growth of endpoint adjudication services within Axio. This role ensures the design and execution of independent, blinded, and regulatory-compliant adjudication processes meet sponsor expectations and support high-quality regulatory submissions. Key Responsibilities Strategic Leadership & Service Delivery
- Define and execute the strategy for clinical endpoint adjudication services within Axio.
- Ensure consistent, high-quality delivery across a portfolio of global clinical trials.
- Drive operational scalability, standardization, and innovation.
- Establish and monitor KPIs related to quality, timelines, and client satisfaction. Clinical Endpoint Committee (CEC) Management
- Support selection and management of independent physician adjudicators.
- Ensure training, calibration, and performance monitoring.
- Maintain independence and integrity of blinded adjudication processes. Operational Execution & Oversight
- Oversee end-to-end adjudication workflows.
- Ensure adherence to study timelines and milestones.
- Identify operational risks and optimize resources. Regulatory Compliance & Quality Assurance
- Ensure compliance with
ICH-GCP, FDA, EMA
requirements.- Maintain inspection-ready processes and documentation.
- Support audits and regulatory inspections. Client & Stakeholder Engagement
- Serve as senior contact for sponsors.
- Participate in RFPs, proposals, and bid defenses.
- Build strong client relationships. People Leadership & Development
- Lead and develop adjudication services teams.
- Foster a culture of excellence and continuous improvement. Education & Experience
- Bachelor's degree (Master's preferred)
- 12-15+ years in clinical research or adjudication
- CRO or sponsor-facing experience required
- Experience with adjudication services Skills & Competencies
- Knowledge of ICH-GCP and regulatory frameworks
- Understanding of clinical trial design and endpoints
- Strong leadership and communication skillsCytel Inc.