Senior Director, Medical Review

Syneos Health is seeking a Senior Director, Medical Review to lead a team of Medical Review Directors. The successful candidate will be responsible for performing physician review and medical interpretation of patient profiles, validating medically significant findings, and preparing concise medical data review summaries.

Patient Profile Review

• Perform physician review and medical interpretation of patient profiles in accordance with study procedures, project plans, and timelines.
• Document findings and identify issues requiring clarification, follow-up, or escalation.

Medical Validation and Triage

• Validate medically significant findings identified through Medical Scientist-led data review without duplicating the primary review.
• Assess the medical relevance of trends, potential signals, protocol-related concerns, and subject-level findings; determine appropriate disposition and escalation.
• Provide medical clarification and guidance to Medical Scientists regarding review findings.

Medical Review Reporting and Escalation

• Prepare concise medical data review summaries for Regional Medical Directors highlighting significant findings, emerging trends, potential subject safety concerns, outstanding questions, and items requiring action.
• Communicate and escalate validated findings with sufficient clinical context and medical rationale to support Regional Medical Director site and sponsor guidance, Medical Director assessment, and study oversight.

Quality, Collaboration, and Compliance

• Participate in calibration, quality review, and process improvement activities to promote consistent, timely, and traceable medical review outputs.
• Partner with Medical Scientists and relevant project functions to support effective review handoffs and timely awareness of emerging concerns.
• Adhere to enterprise policies, SOPs, work instructions, project plans, customer requirements, ICH-GCP guidelines, and applicable regulations.

Team Leadership

• Represents the Team in cross-departmental meetings and activities in support of MSM initiatives and objectives.
• Leads and develops a team of Medical Review Directors building a culture that develops, attracts, and retains key talent and fosters a high-performance culture.