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.
ResponsibilitiesKey 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.
QualificationsEducation & 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 skills
Cytel Waltham, Massachusetts, USA Office
1050 Winter Street, Suite 2700, Waltham, MA, United States, 02451
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