The Opportunity

You will report to the COO and work with Researchers, Wet and Dry Lab teams, Regulatory/ Quality/Operations teams and Universal DX' external partners. You will play an integral role in contributing towards the Company's future growth by leading and ensuring the successful development and scale-up of commercial in vitro diagnostic (IVD) assays that use next-generation sequencing (NGS). You will ensure that both the assay and bioinformatics pipelines are built together and properly integrated to realize a successful product.
The VP of Product Development will be a seasoned leader who is able to build, scale, and motivate teams for CLIA and FDA regulated product development. This strategic leadership role will lead Universal Dx towards the aggressive growth of business with a focus on innovative product design and development.
You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want 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 starting 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

• Development and execution of the overall Diagnostic Product Development plan that supports commercialization timelines.
• Ensure prioritization of development activities across the globe and that projects are staffed with appropriate resources
• Define and execute a strategy for tech transfer across multiple laboratorie
• Develop and leverage partnerships effectively with cross functional teams
including Research, Clinical, Quality, and Regulatory to achieve business result
• Serve as the technical lead on assay development activities, which will be under design control

What you'll bring

• Master's, or Ph.D. degree in a Life Science, Biotechnology, or similar relevant field.
15+ years of experience in product and technology development, 10+ years of experience directly managing assay development team, and 3-5 of those years managing leaders within a Diagnostic Product Development function
• Proven track record with regulatory requirements and standards for IVD assays (e.g., CLIA, CAP, FDA)
• Proven track record of working with different molecular biology techniques, nucleic acid extraction, NGS workflows, and other relevant technologies
• Proven track record of successful assay development and validation in a clinical or diagnostic setting
• Prior experience developing automated workflows preferre
• Direct knowledge and experience with developing of a product regulated as
a single site PMA (ssPMA) preferred
• Excellent leadership, communication, and interpersonal skills combined with
strategic and problem-solving thinking capabilit
• Experience working in a matrix environment
• Demonstrated ability to deliver on time, on budget in a fast-paced lean environment.

• Ability to understand cross-functionally, both wet-lab and dry-lab processes in the context of broader organizational objectives
• Ability and willingness to travel 30% of the time, internationally.

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What we'll offer

• Flexible work schedule
• Remote worw
• A global family assistance policy with paid time off following the birth or adoption of a child
• Accrued time of
• Company-sponsored benefit plans which include Paid Time Off, Medical, Dental, Vision, 401(k
• Free day on your birthday
• Possibility to buy extra vacation day
• And more to come....

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