Principal Program Manager

Role overview

This is a senior program management role within an in-vitro diagnostics (IVD) organization developing blood-based cancer screening tests. The position sits at the intersection of wet-lab product development and the cross-functional teams that move a diagnostic assay from concept through commercialization, including automation, software, quality, regulatory, clinical, manufacturing, and supply chain.

Responsibilities

- Drive integrated planning and 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, resourcing, budgets, timelines, and key decision points. - Bridge wet-lab development with automation and software teams, keeping requirements, interfaces, dependencies, and verification activities aligned. - Coordinate with Quality, Regulatory, Lab Operations, Clinical, Manufacturing, and Supply Chain so design-control and operational deliverables are embedded in the program plan. - Identify planning gaps, technical and execution risks, and change impacts; develop mitigation options and escalate with clear recommendations. - Facilitate cross-functional working sessions, capture decisions and actions with owners and due dates, and maintain integrated schedules, dashboards, and executive-ready reporting.

Requirements

- 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 experience in diagnostics, medical devices, or life-science product development, including substantial responsibility for complex cross-functional programs. - Hands-on IVD product development experience, either as a scientist or technical lead driving execution, or as a dedicated product development program manager. - 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 content, ask sharp questions, weigh 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.

Nice to have

- Proficiency with program management tools such as Smartsheet, Jira, Confluence, and Microsoft 365. - PMP certification or equivalent.

Benefits and work setup

- 22 days of paid time off, with the option to carry over up to 10 days into the following year. - Company-observed holidays plus a birthday off. - Employer-sponsored medical, dental, and vision insurance, plus life, short-term disability, long-term disability, and a 401(k) plan. - Flexible work schedule.