Director of IVD Test Development at Cleveland Diagnostics Inc.

Job Overview

Essential Responsibilities and Duties

• Build and manage a team to support the development and validation of products using Cleveland Diagnostics' proprietary IsoClear platform.
• Lead development and validation of new products, using Good Laboratory Practice (GLP) and aligned with regulatory requirements to support PMA, 510K, and/or IVDR approval.
• Design and execute complete analytical validation packages in support of regulatory submissions.
• In collaboration with statistics/data analysis team and in alignment with CLSI guidelines and regulatory agencies, ensure appropriateness of sample sizes and acceptance criteria for analytical validation studies.
• Ensure appropriate analysis and result interpretation for internal reports, regulatory filings and as needed, for external publications (may include scientific meetings and support of manuscript development).
• Maintain a positive culture by championing inclusion, respect and empathy toward all Cleveland Diagnostics colleagues, collaborators, and its community.
• Develop and manage budget related to product validation projects.
• Communicate any product related risks, obstacles, and/or challenges that could delay projects or lead to product failure to leadership.
• Stay current of all relevant CLSI and regulatory guidelines.
• Ensure compliance to all applicable FDA, ISO, Cleveland Diagnostics' Quality System, and safety requirements.
• Responsible for managing large and/or multiple concurrent projects.

Qualifications/Requirements

• Minimum of bachelor's degree in chemistry, biochemistry, or related field (master's or PhD preferred).
• Minimum of 10 years of experience in designing and executing validation plans for In Vitro Diagnostics (IVD). Must have a proven track record with Class III devices (immunoassay and oncology experience preferred).
• Extensive knowledge of immunoassay protocols, analyzers, (research and clinical) and workflows.
• Knowledge of advanced assay technologies, including molecular and protein assays and combination thereof preferred.
• Strong knowledge of CLSI Guidelines, FDA regulations (e.g., 21 CFR 820) and IVDR standards including prior experience with validation of in vitro diagnostics for PMA and 510K approval.
• Demonstrated proficiency managing product development and lifecycle under Design Control (21 CFR 820).
• Minimum 5 years of experience in a leadership role managing scientific staff in diagnostics company (e.g., manager, director).
• Demonstrated experience managing multiple complex projects; proven track record of delivering projects on time and on budget.
• Must possess strong verbal and written communication skills with demonstrated ability leading effective collaboration and building team cohesion, Demonstrable ability to adapt communication style to suit different internal and external audiences, such as employees, colleagues, management, regulatory bodies, scientific audiences, etc.
• Ability to work effectively in a cross-functional team environment.
• Critical thinking and independent decision-making skills.
• Excellent aptitude for troubleshooting assay workflows and laboratory equipment.
• Self-starter with high motivation level and eagerness to learn.

Physical Requirements/Working Conditions/Equipment Used:

• Fine motor skills and manual dexterity to handle specimens and lab equipment required to process specimens, troubleshoot and repair instrumentation.
• Visual acuity to examine specimens and reagents
• Offices reachable by elevator but should be able to climb stairs in case elevator out
• Heavier lifting may be required (up to 50 pounds)
• Ability to operate a computer and other technology related lab equipment through course of day
• Ability to work in an environment with exposure to hazardous chemicals and biohazards
• Ability to comply with all appropriate job PPE requirements
• General office noise and HVAC

Other Requirements

• Full-time on-site position. This is not a remote position.
• Position may require some infrequent travel