Director of Clinical Strategy & Trials

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

Benefits offered by this job

Health care plan (medical, vision, and

dental insurance

Annual incentive bonus

Paid time off

Parental leave

Bereavement leave

401(k)

Job summary

Sysmex America, Inc. in Lincolnshire, IL, seeks a Director of Clinical Affairs to develop and execute clinical strategies for new and modified IVD products.

You will manage preclinical and clinical plans, ensure FDA/GLP/GCP compliance, and act as Principal Investigator for IRB-approved studies in the RACA Laboratory. This role requires a strong background in clinical research, leadership of cross-functional teams, and the ability to coordinate with external sites, budgets, and regulatory

Qualifications

• Master’s degree in a medical/science field; PhD desired.
• Minimum 10+ years of clinical research experience with 8+ years leading clinical projects.
• Experience with preclinical and clinical study evaluations.
• In-depth knowledge of regulations (GCP, GLP) affecting IVD studies.

Responsibilities

• Develop and execute clinical strategies for new/modified Sysmex IVD products.
• Ensure FDA/CLSI guidelines, GCP requirements, and regulatory submissions compliance.
• Serve as Principal Investigator for IRB-approved studies in the RACA Laboratory.
• Manage documentation: study protocols, CRFs, informed consent, monitoring plans.

Skills

GCP/GLP knowledge

Clinical project leadership

Regulatory knowledge

Laboratory IT skills

Strong communication

Interpersonal skills

English language

Statistics basics

Education

Master's degree in Medical/Science

PhD degree desired

Tools

Microsoft Office

LIS systems

Job description

Sysmex America, Inc. in Lincolnshire, IL, seeks a Director of Clinical Affairs to develop and execute clinical strategies for new and modified IVD products.

You will manage preclinical and clinical plans, ensure FDA/GLP/GCP compliance, and act as Principal Investigator for IRB-approved studies in the RACA Laboratory. This role requires a strong background in clinical research, leadership of cross-functional teams, and the ability to coordinate with external sites, budgets, and regulatory