Job Opportunity: Director of IVD Test Development
Title: Director of IVD Test Development
Location: Onsite – OH
Job Overview:
We are seeking a Director of IVD Test Development to lead the transformation of a novel class of In Vitro Diagnostics into commercially ready products for early cancer and neurological disease detection. This role involves overseeing product development and validation to support PMA, 510(k), and IVDR approvals. The position requires collaboration across Research and Development, Regulatory Affairs, Quality Assurance, and Marketing.
Key Responsibilities:
- Build and manage a team for developing and validating products based on a proprietary diagnostics platform.
- Lead development and validation efforts aligned with GLP and regulatory requirements (PMA, 510(k), IVDR).
- Design and execute comprehensive analytical validation studies for regulatory submissions.
- Collaborate with statistical teams to ensure proper study design and alignment with CLSI and regulatory guidelines.
- Analyze and interpret results for internal reports, regulatory filings, and external publications.
- Maintain a culture of inclusion, respect, and empathy across the organization.
- Develop and manage budgets for product validation projects.
- Communicate risks and challenges to leadership proactively.
- Stay current with CLSI guidelines and relevant regulatory standards.
- Ensure compliance with all applicable FDA, ISO, Quality System, and safety requirements.
- Oversee multiple large and complex projects concurrently.
Qualifications:
- Bachelor's degree in chemistry, biochemistry, or related field (Master's or PhD preferred).
- At least 10 years of experience in IVD validation, including Class III devices (immunoassay and oncology experience preferred).
- Strong knowledge of immunoassay protocols, analyzers, and advanced assay technologies.
- Expertise in CLSI guidelines, FDA regulations (21 CFR 820), and IVDR standards.
- Proven experience with PMA and 510(k) submissions and design control processes.
- Minimum 5 years of leadership experience managing scientific teams in a diagnostics company.
- Demonstrated ability to manage multiple complex projects with successful outcomes.
- Excellent verbal and written communication skills tailored for diverse audiences.
- Critical thinking, independent decision-making, and troubleshooting skills.
Physical Requirements:
- Fine motor skills for handling specimens and lab equipment.
- Ability to lift up to 50 pounds and climb stairs if necessary.
- Proficiency with computers and lab technology.
- Work in environments with exposure to hazardous chemicals and biohazards.
- Compliance with PPE requirements.
Other Details:
- Full-time, onsite position. Not remote.
- Infrequent travel may be required.
This is a pivotal role in driving innovation and advancing diagnostic solutions. If you are passionate about leading impactful projects and fostering a collaborative team environment, we encourage you to apply!