Director of Clinical/Regulatory Affairs

SUMMARY:

The Director of Clinical/Regulatory Affairs will be responsible for managing all aspects of Clinical Study related activities for assigned projects, and accountable for timely delivery of clinical tasks at the project level as defined by the project scope and timeline.

The Director of Clinical/Regulatory Affairs will also support/guide global product market clearance/registration, including 510k and IVDR.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

To perform this job successfully, an individual must be able to perform essential duties and responsibilities satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Work closely with Cytek personnel and clinical trial project teams to develop clinical study strategies according to the characteristics of the product and intended use
• Work closely with clinical trial project teams to develop informed consent, obtain IRB approval, and investigate financial statements
• Develop clinical study protocol synopsis, including performing literature reviews and analyses to provide clinical and scientific evidence to support clinical study designs
• Work closely with clinical trial project teams to write, review, and approve clinical study protocols and reports, address protocol deviation, obtain required regulatory approval before enrollment
• Work closely with a biostatistician on statistical plans such as sample size, statistical method, primary objective and the statistical acceptance criteria
• Work closely with clinical trial project teams to coordinate/facilitate investigator meetings and adverse event reporting
• Work closely with clinical data management teams to develop electronic data capturing (EDC) systems and data management plans
• Work closely with clinical trial project teams to develop/review site monitoring plans, coordinate/facilitate site audits, identify potential compliance and data discrepancy issues, and ensure that all clinical study participants follow protocols with data sets captured accurately
• Develop/review clinical study operation plans and budgets, coordinate clinical site selection, site qualification, site initiation, site training and site monitoring
• Coordinate/facilitate dataset validation and pre-analysis to ensure clinical data integrity and consistency
• Effectively communicate pertinent data-related information to appropriate project team members
• Work with key opinion leaders in the field to obtain feedback to align product definition and intended use with clinical study protocol development
• Function as a clinical area expert on project teams and contribute to assay development, data analysis, interpretation, and software feature evaluation
• Be able to conduct firsthand laboratory testing, data analysis and troubleshooting to assist clinical study design and protocol development
• Support FDA Q-submissions, assist in preparation and publishing of 510(k) and EU IVDR regulatory submissions/registrations
• Assist in preparing regulatory documents to support global product market clearance and registration

REQUIREMENTS & QUALIFICATIONS:

The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Demonstrated success in conducting clinical trials in United States and Europe preferred
• BS, MS or PhD in medical technology or related field with at least 10 years of laboratory experience in medical device or biotechnology industry, CLIA lab experience preferred.
• Demonstrated knowledge and firsthand experience with flow cytometry practices in clinical applications, such as immunodeficiency diagnosis/monitoring, leukemia and lymphoma diagnosis and minimum residual disease monitoring
• Experience with clinical study protocol development following GCP, GLP and applicable regulatory requirements
• Experience with successfully managing clinical studies for medical device/IVD supporting 510(k) or CE IVD submissions
• Deep understanding of CLIA, GLP, and GCP requirements
• Firsthand experience in blood sample preparation and flow cytometry operations for sample data collection and data analysis is a plus
• Experience with statistical analysis and software development required
• Demonstrated success in guiding medical device or IVD device product approval/clearance for United States, Europe, and other global clinical markets
• Established prior working relationships with regulatory authorities, e.g., FDA, MHRA, EU Notified Body and Competent Authority, etc.
• Strong verbal and written communication skills, and the willingness to coordinate clinical trials in a functionally fast paced and dynamic environment

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

The physical demands described here are representative of those that an employee must meet to perform the essential functions of this job successfully.Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.