New · posted Oct 31
Sysmex America · Medical Devices
Director, Clinical Affairs
- Lincolnshire, IL
- On-site
- Full-time
- Director
The role
Find a Better Way...
...to use your skills and experience.
This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.
...to improve the lives of others.
Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.
...to build a promising future.
What you need
Master’s degree required (Medical/Science background highly desired), PhD degree desired. A minimum of 10+ years of clinical research experience required with 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.
Skills named in this posting
What you'll do
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, to develop preclinical and clinical evaluation plans including study protocols; determine study documentation requirements; and generate 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.
1. 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. 2. 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.3. 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.4. 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.5. 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, communicate with leadership as appropriate.6. 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.7. Establish and maintain relationships with outside institutions required to conduct the appropriate evaluations including recruiting investigational sites, negotiating and maintaining budgets and contracts. 8. Contribute to clinical sections of regulatory submissions 9. Generate and author final reports appropriate to support regulatory filings.10. Other duties as required.
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.
Pay and benefits
$168,490 – $264,000 a year
Employer providedHealth care plan (medical, vision, dental)
Annual incentive bonus
Paid time off
Parental leave
Bereavement leave
401(k)
Where you'll work
Lincolnshire, ILOn-siteOpen in Maps (opens in a new tab)
More jobs in Lincolnshire, ILWorking conditions
Percentage of Travel: Up to 35% of time
Physical Risk: Regular exposure to risk that may require alertness, but with minimal precautions.
Equal opportunity, accessibility and legal noticesSysmex America's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This roleEmployer provided
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $168,490 | — | $264,000 |
This role: Sysmex America's own published range.
Career trajectory
Where this role sits in Clinical Affairs
The general path across 4 open Clinical Affairs roles on Regulatory Jobs, with the titles they carry most. Not Sysmex America's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct6
- Lab testing and methods5
- Collaboration and leadership4
- GMP and compliance3
- Documentation and SOPs2
- Investigations and CAPA2
- Data and digital systems2
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Sysmex America on Regulatory Jobs
- 2
- Open roles
- 2
- Distinct roles
- 1
- Locations
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