Senior Director, Clinical Endpoint Adjudication Services

at Cytel in Topeka, Kansas, United States

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 skills

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.