Director, Clinical Affairs

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

Benefits offered by this job

Health care plan

Annual incentive bonus

Paid time off

Parental leave

Bereavement leave

401(K)

Job summary

Sysmex Corporation in Lincolnshire, Illinois, is seeking a Director of Clinical Affairs to develop and execute clinical strategies for new and modified IVD products. You will oversee preclinical/clinical evaluations, ensure FDA/GCP/GLP compliance, and manage IRB-approved studies in the RACA Laboratory.

You will lead cross-functional teams, coordinate with internal Sysmex affiliates, and mentor staff to deliver high-quality clinical documentation and regulatory submissions.

Qualifications

• Minimum 10+ years of clinical research experience.
• Experience leading clinical projects, including military exposure.
• In-depth knowledge of preclinical and clinical study evaluations.
• Knowledge of FDA/CLS and GCP/GLP guidelines.
• Strong communication and interpersonal skills.

Responsibilities

• Develop and execute clinical strategies for Sysmex IVD products, including preclinical and clinical evaluation plans.
• Manage clinical documentation: CRFs, informed consent, monitoring plans, and regulatory filings.
• Oversee IRB-approved studies and operations of the RACA Laboratory; act as Principal Investigator.
• Coordinate with external institutions, investigators, and budget/contract activities.
• Ensure timely milestone delivery and data management across projects.

Skills

Clinical research

Regulatory knowledge

GCP/GLP knowledge

Leadership

English

Education

Master’s degree

PhD

Tools

Microsoft Office/Outlook

Adobe

LIS

Job description

Overview

Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois.

Responsibilities

We currently have a great opportunity available for a Clinical Affairs Director. The Director, Clinical Affairs will be responsible for developing, coordinating, and executing the clinical strategy for new and modified Sysmex IVD products. This position will be responsible for understanding the operating principles of the devices required, developing preclinical and clinical evaluation plans including study protocols, determining study documentation requirements, and generating final reports and sections of FDA applications. The position will also be responsible for ensuring the operations of the Sysmex clinical laboratory, including functioning as the Principal Investigator for IRB‑approved studies conducted in the RACA Laboratory. The Director will also be responsible for maintaining relationships with outside institutions required to conduct the evaluations.

Essential Duties and Responsibilities:

• Direct and comply with all policies, established procedures, and regulations related to the studies. Maintain professional, product and market expertise via independent reading, networking and training.
• Develop and execute clinical strategies for new/modified Sysmex IVD products, including the development of preclinical and clinical evaluation plans in compliance with FDA and CLSI guidelines, GCP requirements, and recent FDA submissions for similar products. Function as a subject‑matter expert where appropriate. Integrate clinical strategy with colleagues at S‑Corp and other Sysmex affiliates.
• Execute evaluations as above in alignment with business goals and objectives. Responsible for establishing, managing, and achieving project milestones with internal staff, other departments, and all study investigators and research coordinators.
• Ensure that associates are accountable for timely development of clinical trial documentation including instructions for use, case report forms (CRFs), CRF guidelines, informed consent, monitoring plans and reports, assisting with study protocol development and other necessary clinical/regulatory documentation. Mentor and support staff to achieve success and excellence in these areas.
• Oversee the progress of projects and assure adherence to intended timelines including enrollment, clinical supplies, and data management/delivery. Identify issues that may impact the overall project plan and initiate contingency plans, communicating with leadership as appropriate.
• Direct the operations of the Sysmex RACA Laboratory in close alignment with the Laboratory Manager and function as the Principal Investigator for IRB‑approved studies.
• Establish and maintain relationships with outside institutions required to conduct the appropriate evaluations, including recruiting investigational sites, negotiating and maintaining budgets and contracts.
• Contribute to clinical sections of regulatory submissions.
• Generate and author final reports appropriate to support regulatory filings.
• Other duties as required.

Percentage of Travel: Up to 35% of time

Physical Risk: Regular exposure to risk that may require alertness, but with minimal precautions.

Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.

Qualifications

• Master’s degree required (Medical/Science background highly desired), PhD degree desired. A minimum of 10+ years of clinical research experience required with a minimum of 8 years’ experience leading clinical projects, including experience in the Armed Forces.
• Experience in all aspects of preclinical and clinical study evaluations.
• Technical laboratory instrument expertise/experience.
• In‑depth knowledge of regulations and industry standards affecting preclinical and clinical studies of IVD products, including GCP & GLP.
• Technical expert in the various aspects of the clinical evaluation process.
• History of significant contribution to the success of planning and executing clinical strategies in support of product clearance.
• Knowledge of regulations and standards affecting clinical and preclinical studies of Sysmex products.
• English.
• Excellent general IT skills i.e. Microsoft Office/Outlook, Adobe, etc., and basic statistics. Laboratory &/or LIS computer skills would be a plus.
• Ability to follow guidelines and effectively communicate scientific data in a structured manner. Understands and interprets scientific data related to regulatory requirements and strategy and provides knowledge and expertise to guide others.
• Strong interpersonal skills, ability to interface effectively with all levels of staff and management, both internally and externally.
• Excellent organizational skills and attention to detail.
• Ability to manage multiple priorities.

The salary range for this role is $168,490 - $264,000. Within this range, individual pay is determined by work location and additional factors, including job‑related skills, experience, and relevant education or training. The total compensation package for this position also includes a choice of health care plan (medical, vision, and dental insurance), an annual incentive bonus, paid time off, parental leave, bereavement leave and a 401(K) for all eligible employees.

This job requires satisfaction of the credentialing requirements of Sysmex’s customers, including hospitals and other healthcare facilities, which generally includes proof of current vaccinations for measles, mumps, rubella, varicella (chicken pox), and COVID‑19.

Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug‑free workplace and perform pre‑employment substance abuse testing.