Sr. Director, Clinical Affairs

Sysmex•Buffalo Grove, IL

2d•$210,000 - $330,000•Onsite

About The Position

Sysmex, headquartered in Kobe, Japan, with a location in Lincolnshire, Illinois, is a global leader in diagnostic equipment and information management systems. The company focuses on applying science to enhance the quality of life through breakthroughs in laboratory diagnostics, information technology, workflow analysis, and life sciences. They are seeking a Senior Director, Clinical Affairs to join their team.

Requirements

Master’s degree required (Medical/Science background highly desired).
A minimum of 15+ years of clinical research experience required.
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.
Excellent general IT skills (Microsoft Office/Outlook, Adobe, etc.) and basic statistics.
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.
English language proficiency.
Proof of current vaccinations for measles, mumps, rubella, varicella (chicken pox), and COVID-19.

Nice To Haves

PhD degree desired.
Laboratory &/or LIS computer skills would be a plus.

Responsibilities

Developing, coordinating, and executing the clinical strategy for new and modified Sysmex IVD products.
Understanding device operating principles to develop preclinical and clinical evaluation plans, including study protocols.
Determining study documentation requirements and generating final reports and sections of FDA applications.
Ensuring the operations of the Sysmex clinical laboratory and functioning as the Principal Investigator for IRB-approved studies.
Maintaining relationships with outside institutions for conducting evaluations.
Directing and complying with all policies, established procedures, and regulations related to studies.
Maintaining professional, product, and market expertise.
Integrating clinical strategy with colleagues at S-Corp and other Sysmex Affiliates.
Executing evaluations in alignment with business goals and objectives.
Establishing, managing, and achieving project milestones with internal staff, other departments, and study investigators/coordinators.
Ensuring associates are accountable for timely development of clinical trial documentation (instructions for use, CRFs, informed consent, monitoring plans/reports, etc.).
Mentoring and supporting staff to achieve success and excellence.
Overseeing project progress and assuring adherence to timelines, including enrollment, clinical supplies, and data management/delivery.
Identifying issues that may impact the project plan and initiating contingency plans.
Directing the operations of the Sysmex RACA Laboratory and functioning as the Principal Investigator for IRB-approved studies.
Establishing and maintaining relationships with outside institutions, including recruiting investigational sites and negotiating budgets/contracts.
Contributing to clinical sections of regulatory submissions.
Generating and authoring final reports to support regulatory filings.
Performing other duties as required.