Director, Clinical Affairs

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.

Essential Duties and Responsibilities:

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.

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.

• 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.