Principal Program Manager

Universal Diagnostics; United States; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

22 days PTO with carryover

Holidays, Birthday off

Medical, dental, and vision insurance

Life, STD, LTD, 401(k)

Flexible work schedule

Job summary

Universal DX, Inc. is seeking a highly experienced Program Manager to join our growing Program Management team.

You will translate scientific and product strategy into executable plans, serving as the primary bridge between wet-lab development and automation, software, quality, regulatory, and manufacturing. You will lead integrated planning across assay, reagent, and pre-analytical workstreams, align with cross-functional leads, and drive timely decisions, with a focus on delivering our IVD

Qualifications

• Eight or more years of relevant experience in diagnostics, medical devices, or life science product development.
• Experience driving complex cross-functional programs.
• Direct IVD product development experience as a scientist or technical lead or as a program manager.
• Experience supporting wet-lab product development and cross-functional collaboration.
• Strong knowledge of ISO 13485, design controls, risk management, verification and validation, and DHF deliverables.
• Ability to translate complex scientific content into clear plans and decisions.
• Strong facilitation and executive communication skills, with influence without direct authority.
• PMP or similar certification preferred.

Responsibilities

• Lead integrated planning and support execution for assay, reagent, and pre-analytical development workstreams across the IVD product lifecycle.
• Partner with scientific and functional leads to define scope, deliverables, success criteria, resources, budgets, timelines, and decision points.
• Connect wet-lab plans with automation and software development, ensuring requirements, interfaces, dependencies, and verification activities remain aligned.
• Coordinate with Quality, Regulatory, Lab Operations, Clinical, Manufacturing, and Supply Chain so design-control and operational deliverables are incorporated into the program plan.
• Proactively identify planning gaps, technical and execution risks, and change impacts; develop options and mitigation plans and elevate with clear recommendations.
• Facilitate cross-functional working sessions and workstream meetings; document decisions, actions, owners, and due dates and drive timely closure.
• Maintain integrated schedules, dashboards, and executive-ready reporting, while mentoring PM colleagues and strengthening consistent planning practices across Product Development.

Skills

Strong facilitation

Stakeholder management

Executive presentation

Written communication

Program management

Education

Bachelor's degree in biology/related field

Advanced degree preferred

Tools

Smartsheet

Jira

Confluence

Microsoft 365

Job description

About our Company:

Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers.

The Opportunity:

Universal DX is seeking a highly experienced program manager to join our growing Program Management team. Reporting to the Director, Program Management, this role will partner closely with Assay Development, Reagent Development, and Pre-Analytical Development to translate scientific and product strategy into executable plans. The role will serve as the primary program-management bridge between wet-lab Product Development and Automation, Software Development, Quality, Regulatory, Lab Operations, Manufacturing, Supply Chain, and other cross-functional partners supporting development and commercialization of Universal DX IVD products.

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”.

How you'll contribute:

• Lead integrated planning and support execution for assay, reagent, and pre-analytical development workstreams across the IVD product lifecycle.
• Partner with scientific and functional leads to define scope, deliverables, success criteria, resources, budgets, timelines, and decision points.
• Connect wet-lab plans with automation and software development, ensuring requirements, interfaces, dependencies, and verification activities remain aligned.
• Coordinate with Quality, Regulatory, Lab Operations, Clinical, Manufacturing, and Supply Chain so design-control and operational deliverables are incorporated into the program plan.
• Proactively identify planning gaps, technical and execution risks, and change impacts; develop options and mitigation plans and elevate with clear recommendations.
• Facilitate cross-functional working sessions and workstream meetings; document decisions, actions, owners, and due dates and drive timely closure.
• Maintain integrated schedules, dashboards, and executive-ready reporting, while mentoring PM colleagues and strengthening consistent planning practices across Product Development.

What you'll bring:

• Bachelor's degree in biology, chemistry, biotechnology, bioengineering, or a related scientific or engineering discipline; an advanced degree is preferred.
• Eight or more years of relevant experience in diagnostics, medical devices, or life science product development, including substantial responsibility for complex cross-functional programs.
• Direct IVD product development experience gained either as a scientist or technical lead who has driven program execution, or as a program manager dedicated to Product Development functions.
• Demonstrated experience supporting wet-lab product development functional areas and working cross-functionally with other functions.
• Strong working knowledge of regulated product development, design controls, risk management, verification and validation, and design history file deliverables under an ISO 13485 quality system.
• Ability to understand scientific and technical content, ask effective questions, research alternatives, and translate complex work into clear plans and decisions.
• Strong facilitation, stakeholder management, written communication, and executive presentation skills, with the ability to influence without direct authority.
• Proficiency with program management methods and tools; experience with Smartsheet, Jira, Confluence, and Microsoft 365 and a PMP or similar certification are highly preferred.

What we’ll offer:

We’re proud to offer exceptional corporate benefits which include:

• 22 days of PTO with the possibility to carry over 10 days to the following year.
• Company Holidays, plus your Birthday off!
• Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).
• Flexible work schedule
• And more to come!

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.