Director, Clinical Strategy & Regulatory Affairs

Sysmex America, Inc; Lincolnshire (IL); On-site; USD 168,490 - 264,000; Full time

Benefits offered by this job

Health insurance

Annual incentive bonus

Paid time off

Parental leave

401(k)

Job summary

Sysmex America, Inc is seeking a Director, Clinical Affairs in Lincolnshire, IL. This senior role develops and executes the clinical strategy for Sysmex IVD products and acts as Principal Investigator for IRB-approved studies in the RACA Laboratory.

You will coordinate with internal teams and external institutions to drive clinical programs and regulatory submissions. The candidate will lead multi-disciplinary efforts, ensure compliance with FDA/GLP/GCP guidelines, and direct documentation,

Qualifications

• Requires 10+ years in clinical research with 8+ years leading clinical projects
• Experience in preclinical and clinical study evaluations
• Knowledge of FDA/CLS I guidelines, GCP & GLP

Responsibilities

• Develop and execute clinical strategies for new/modified Sysmex IVD products
• Serve as Principal Investigator for IRB-approved studies in the RACA Laboratory
• Manage project milestones, timelines, budgets, and cross-functional coordination
• Prepare clinical trial documentation and regulatory submissions sections
• Build and maintain relationships with external institutions and investigators
• Oversee laboratory operations and ensure adherence to regulatory standards

Skills

Clinical leadership

Regulatory knowledge

GCP/GLP knowledge

Project management

Communication of scientific data

Interpersonal skills

Statistics basics

English proficiency

Education

Master's degree

PhD preferred

Tools

Microsoft Office

Job description

Sysmex America, Inc is seeking a Director, Clinical Affairs in Lincolnshire, IL. This senior role develops and executes the clinical strategy for Sysmex IVD products and acts as Principal Investigator for IRB-approved studies in the RACA Laboratory.

You will coordinate with internal teams and external institutions to drive clinical programs and regulatory submissions. The candidate will lead multi-disciplinary efforts, ensure compliance with FDA/GLP/GCP guidelines, and direct documentation,