Senior PM, Cancer Diagnostics & IVD Programs

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

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