The Opportunity

Reporting to the VP of Product Development, this role will work cross-functionally in the planning, design, and execution of development studies characterizing the impact of pre-analytical variables on Universal DX's screening test for colorectal cancer. Additionally, this role will work with external and internal stakeholders for regulatory approval of the blood collection device used for the colorectal cancer screening test.
You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancer. As part of the team, you will be in a Company that aims to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and scaling our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships. We are looking for passionate changemakers to be a part of our journey in this expansive time for us.

How you'll contribute

Lead R&D Scientists and Research Associates in characterizing the impact of pre-analytical variables on the analytical performance of NGS-based diagnostic assay(s).
Provide leadership and technical expertise in experimental design, execution, and data
analysis following CLSI guidelines.

Function as a technical SME in the design and execution of Development studies focused on comparing the performance of different blood collection devices to identify candidates suitable for use with Universal DX's colorectal cancer test.

Collaborate with external and internal stakeholders to define the validation strategy for FDA
approval of the blood collection device chosen for Universal DX's colorectal cancer
test.

• Oversee the selection of a sample collection kit for Universal DX's colorectal cancer test based on physical and functional testing conducted in accordance with regulatory guidelines
• Assist with regulatory and quality guidance for experimental and validation study design
• Provide expert leadership in troubleshooting and assay optimization
• Develop and deliver scientific presentations and participate in project teams
• Manage and supervise people, conduct performance evaluations, and offer mentorship to junior
members on the team
• Author development reports, SOPs, and technical documents to support regulatory submissions
• Provide input for annual budget and timeline planning
• Align with department and corporate goals
• Review and approve study deviation investigations, change control, and CAPA
• Ability to travel 10% of working time away from work location, may include overnight/weekend
travel

Qualifications

• Ph.D/MS/BS in Molecular Biology/Biochemistry/Genetics or related field.
• Experience in a regulated environment is a must and prior experience as a technical lead in developing and commercializing diagnostic tests (IVD/LDT), specifically in oncology is highly desirable.
• Strong understanding of product development process, quality standards, regulatory compliance, as well as risk assessment and mitigation in product development.
• Hands-on experience with NGS-based molecular assay development and in-depth knowledge of industry standards (including CLSI guidelines) related to NGS assays is a strong plus.
• Prior experience in characterizing the impact of pre-analytical variables, including sample collection device(s) and sample collection kit(s) on the performance of NGS-based assays.
10+ years experience managing R&D teams and working cross-functionally in the development and commercialization of clinical diagnostics. Proven leadership in building and growing technical teams.
• Excellent leadership, communication, and interpersonal skills, with a demonstrated ability to collaborate with and influence cross-functional teams and stakeholders.
• Data driven mindset with strong analytical and strategic thinking skills. A proactive and strategic thinker with strong decision-making skills.
• Highly self-motivated and able to independently and effectively drive for results working in a dynamic environment with a sense of urgency and aggressive timelines. Strong organizational skills and ability to adapt to shifting priorities.

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