Senior Director Medical Review

Description

Senior Director, Medical Review

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
  
  

Job Responsibilities

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 subjectlevel
  
  

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.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

The Medical Director, Medical Data Review provides physician-level review of patient profiles and validation of medically significant findings generated through Medical Scientist-led data review. The role interprets patient-level information, prepares medical data review summaries, and escalates significant findings to Regional Medical Directors to inform site and sponsor guidance and study oversight. Serves as a mentor, consultant and manager to Medical Review Directors.

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