[Hiring] Senior Director, Medical Review @Syneos Health

Role Description

Senior Director, Medical Review at Syneos Health® is responsible for the following:

• 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.

Qualifications

• Experience in medical review and interpretation.
• Strong leadership and team development skills.
• Ability to collaborate effectively across departments.
• Knowledge of ICH-GCP guidelines and applicable regulations.

Requirements

• Advanced degree in a relevant field (e.g., MD, PhD).
• Proven track record in medical review processes.
• Excellent communication and presentation skills.
• Ability to work in a fast-paced, dynamic environment.

Benefits

• Career development and progression opportunities.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Inclusive culture where you can authentically be yourself.