Clinical Strategy Director, IVD Innovations

Sysmex America, Inc; Mundelein (IL); Presencial; USD 210.000 - 330.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health plan

Annual incentive bonus

Paid time off

Parental leave

Bereavement leave

401(k)

Descripción de la vacante

Sysmex America, Inc. seeks a Senior Director, Clinical Affairs to lead clinical strategy for new and modified IVD products and manage preclinical and clinical evaluation plans in line with FDA and CLSI guidelines.

The role oversees the Sysmex RACA Laboratory operations, maintains external collaborations, and ensures timely completion of clinical and regulatory documentation, with travel up to 35%.

Formación

• Master’s degree required with 15+ years of clinical research experience.
• Minimum 8 years’ experience leading clinical projects, including Armed Forces experience.
• Strong knowledge of FDA, GCP/GLP, and CLSI guidelines.

Responsabilidades

• Develop and coordinate clinical strategy for new/modified Sysmex IVD products.
• Serve as Principal Investigator for IRB-approved studies and manage study documentation.
• Ensure timely clinical trial documentation, monitoring plans, and regulatory deliverables.

Conocimientos

English language proficiency

Interpersonal skills

Project management

Regulatory & clinical knowledge

Educación

Master’s degree

PhD preferred

Herramientas

Microsoft Office

Adobe

LIS systems

Descripción del empleo

Sysmex America, Inc. seeks a Senior Director, Clinical Affairs to lead clinical strategy for new and modified IVD products and manage preclinical and clinical evaluation plans in line with FDA and CLSI guidelines.

The role oversees the Sysmex RACA Laboratory operations, maintains external collaborations, and ensures timely completion of clinical and regulatory documentation, with travel up to 35%.