Kelly Science, Engineering, Technology & Telecom · 10 hours ago
Program Manager, IVD Development & Validation
Broomfield, CO
Full-time
Onsite
Mid, Senior Level
$83K/yr - $110K/yrKelly Science, Engineering, Technology & Telecom is seeking a Scientific Program Manager to lead the execution of complex in vitro diagnostic (IVD) validation and regulatory programs. The role involves coordinating analytical and clinical testing for FDA and IVDR submissions and requires strong program management skills in a regulated environment.
Staffing & Recruiting
Hiring Manager
Katie F.
Responsibilities
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
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
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
Qualification
Required
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
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)
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
Founded in 1946
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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