Program Manager, IVD Development & Validation

Program Manager, IVD Development & Validation

Broomfield, CO, US

$83,000$110,000 / yr

Manager (Manager / Supervisor)

Full Time, Direct Hire

Medical Devices and Supplies

First Shift (Day)

Scientific

Masters Degree

Overview

We are seeking a Scientific Program Manager to lead the execution of complex in vitro diagnostic (IVD) validation and regulatory programs supporting a broad autoimmune diagnostics test menu. This role is highly program-focused, with primary responsibility for coordinating and delivering large volumes of analytical and clinical testing required for FDA and IVDR submissions.

The position partners closely with a project management organization at a sister company in Germany to align timelines, resources, and deliverables across organizations. The ideal candidate brings strong scientific judgment, disciplined program management skills, and the ability to operate effectively in cross-company, highly regulated environments.

Responsibilities

Program Execution & Cross-Company Coordination

Lead day-to-day program execution for FDA and IVDR submission initiatives supporting autoimmune IVD products

Coordinate closely with a Germany-based sister company to align execution plans, dependencies, and timelines

Translate regulatory strategies and submission requirements into executable program plans covering analytical validation, clinical studies, and documentation

Define and manage milestones, deliverables, and interdependencies across internal teams, external partners, and sister-company functions

Track program progress, provide clear status reporting, identify risks early, and drive mitigation or recovery plans

Analytical & Clinical Testing Oversight

Coordinate large-scale analytical and clinical testing activities required for FDA and IVDR submissions

Ensure study designs, protocols, and execution align with regulatory expectations

Lead scientific and technical discussions to resolve execution challenges and ensure data quality, consistency, and traceability

Review and interpret analytical and clinical data to support program decisions and regulatory readiness

Stakeholder & Governance Management

Serve as the central coordination point across R&D, Clinical, Regulatory, Quality, Manufacturing, and Bioinformatics teams

Interface with external partners, including CROs, clinical sites, reference laboratories, and government agencies as needed

Facilitate program meetings, drive decision-making, and ensure timely issue resolution

Oversee preparation and alignment of protocols, reports, program documentation, and regulatory communications

Qualifications

Required Qualifications

Master's degree or higher in a relevant scientific discipline, or equivalent experience

Experience in scientific or technical program management within regulated diagnostics or medical device environments

Hands-on experience supporting analytical and / or clinical validation of IVD assays

Strong understanding of immunodiagnostic assay development (e.g., ELISA); molecular diagnostics experience is a plus

Experience working under FDA and / or CE / IVDR regulatory frameworks

Working knowledge of design controls, quality systems, and regulated product development lifecycles

Proven ability to manage complex, cross-functional, and cross-company programs

Proficiency in basic statistical analysis

Highly organized, proactive, and adaptable in fast-paced regulatory environments

Preferred Qualifications

PhD in a relevant life science discipline

Direct experience supporting FDA and / or IVDR submissions for autoimmune or immunology-focused IVD products

Experience coordinating large-scale analytical or clinical testing across multiple sites or organizations

Familiarity with formal program management tools (e.g., Microsoft Project)

What Happens Next

Once you apply, your background and experience will be reviewed by the recruiting team. If your qualifications align with the role, you will be contacted to discuss next steps in the interview process. If this position is not the right fit, your information may be considered for future opportunities within the organization.