Director, Clinical Affairs

Sysmex•Buffalo Grove, IL

2d•$168,490 - $264,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

Medical/Science background highly desired
PhD degree desired
Laboratory &/or LIS computer skills would be a plus.

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, 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.