Global Director, Clinical Strategy & Trials

Sysmex America, Inc.; Mundelein (IL); On-site; USD 210,000 - 330,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Parental leave

Job summary

Sysmex America, Inc. in Lincolnshire, IL, invites a Senior Director, Clinical Affairs to lead clinical strategy for new and modified IVD products, develop preclinical and clinical evaluation plans, ensure FDA/CLS I guidelines, GCP/GLP compliance, and serve as Principal Investigator for IRB-approved studies in the RACA Laboratory.

You will manage timelines and budgets, coordinate with internal teams and external investigators, author clinical/regulatory documentation, generate final reports, and

Qualifications

• Minimum 15+ years of clinical research experience; 8+ years leading clinical projects.
• Experience in preclinical and clinical study evaluations.
• Knowledge of FDA/CLS I guidelines, GCP, GLP.
• Experience with regulatory submissions for IVD products.
• Strong IT skills and ability to communicate scientific data.

Responsibilities

• Develop and execute clinical strategy for Sysmex IVD products.
• Coordinate preclinical/clinical evaluation plans in line with FDA/CLSI/GCP.
• Lead IRB-approved studies and act as Principal Investigator in RACA Lab.
• Manage project milestones with internal teams and investigators.
• Prepare regulatory submission sections and final reports.
• Oversee Sysmex RACA Laboratory operations.
• Maintain relationships with external institutions and budgets.

Skills

Clinical leadership

GCP/GLP knowledge

Regulatory knowledge

Project management

English

Data interpretation

Interpersonal skills

MS Office

Education

Master’s degree in Medical/Science

PhD desirable

Tools

Laboratory instruments

LIS systems knowledge

Job description

Sysmex America, Inc. in Lincolnshire, IL, invites a Senior Director, Clinical Affairs to lead clinical strategy for new and modified IVD products, develop preclinical and clinical evaluation plans, ensure FDA/CLS I guidelines, GCP/GLP compliance, and serve as Principal Investigator for IRB-approved studies in the RACA Laboratory.

You will manage timelines and budgets, coordinate with internal teams and external investigators, author clinical/regulatory documentation, generate final reports, and