Sr. Director, Clinical Affairs

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

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 use your skills and experience.
• to improve the lives of others.
• to build a promising future.

Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the 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.

Responsibilities

We currently have a great opportunity available for a Senior Director, Clinical Affairs. The Senior Director, Clinical Affairs will be responsible for developing, coordinating, and executing the clinical strategy for new and modified Sysmex IVD products. This position will understand the operating principles of the devices required, 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 ensure the operations of the Sysmex clinical laboratory, functioning as the Principal Investigator for IRB‑approved studies conducted in the RACA Laboratory. The Senior Director will maintain 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 strategy 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 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, communicate 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 15+ 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 $210,000 – 330,000. 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.