Description
Scientific Program Manager, In Vitro Diagnostics Development & Validation
Focus: Autoimmune Diagnostics – FDA & IVDR Programs
Location: Broomfield, CO
Compensation: $83,000–$110,000 annually (commensurate with experience)
Employment Type: Full-time
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.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
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