Senior Director, Clinical Endpoint Adjudication Services

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 skills