"Alerted.org

Job Title: Scientific Program Manager, In Vitro Diagnostics Development and ValidationJob Description

We are seeking a Scientific Program Manager to drive the execution of complex in vitro diagnostics (IVD) validation and regulatory programs supporting an extensive autoimmune diagnostics test menu. This role is program-focused with primary responsibility for coordinating and delivering large volumes of analytical and clinical testing required for FDA and IVDR submissions. The successful candidate will bring strong scientific judgment, disciplined program management, and the ability to operate effectively across company boundaries in highly regulated environments.

Responsibilities

+ Lead day-to-day program management for FDA and IVDR submission programs supporting autoimmune IVD products.

+ Coordinate closely with the project management group at the sister company to align execution plans, dependencies, and timelines across organizations.

+ Translate regulatory strategies and submission requirements into executable program plans encompassing analytical validation, clinical studies, and supporting documentation.

+ Establish detailed milestones, deliverables, and interdependencies across internal teams, external partners, and sister-company functions.

+ Track program progress, provide clear status reporting, issue early risk warnings, and drive mitigation and recovery plans as needed.

+ Coordinate large-scale analytical and clinical testing activities required for FDA and IVDR filings across an extensive autoimmune IVD test menu.

+ Ensure alignment of study designs, protocols, and execution with regulatory expectations and submission strategies.

+ Lead technical and scientific discussions to resolve execution challenges and maintain data quality, consistency, and traceability across programs.

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

+ Serve as the central coordination point for cross-functional teams, including R&D, clinical, regulatory, quality, manufacturing, and bioinformatics.

+ Interface with external partners such as CROs, clinical sites, reference laboratories, and government agencies as required.

+ Facilitate program meetings, drive decision-making, and ensure timely resolution of issues impacting submission timelines.

+ Oversee preparation and alignment of program documentation, protocols, reports, and sponsor or regulatory communications.

Essential Skills

+ Bachelor's degree or higher in a relevant scientific discipline, or equivalent experience.

+ Demonstrated experience in scientific or technical program management, ideally 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); familiarity with molecular diagnostics is a plus.

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

+ Working knowledge of design control processes, quality systems, and regulated product development lifecycles.

+ Proven ability to manage complex, cross-company programs with multiple stakeholders and high execution demands.

+ Fluent in English; German language skills are a plus.

+ Highly organized, results-driven, and proactive, with the ability to adapt to evolving regulatory and program requirements.

Additional Skills & 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 programs across multiple sites or organizations.

+ Proficiency with formal project/program management tools (e.g., Microsoft Project).

+ Core skills needed include organization, communication, timeline and deadline orientation, proactive effort, and people management.

+ Comfortable challenging the status quo to improve business processes.

Work Environment

Core hours are Monday through Friday, 9 AM to 3 PM, with some flexibility around these hours. The shift for this position covers Monday through Friday, 7 AM to 3:30 PM. Once fully trained and integrated into the team, this position may offer a hybrid work arrangement, with 3 days in office and 2 days working from home. The work environment has a small company, start-up feel with approximately 25 employees, and provides exposure to learning clinical laboratory operations and business flow for clinical testing amino assays. The company is engaged in meaningful R&D projects, including screening for the risk of autism in children and developing antibodies for immuno-assay automated platforms. This position offers a tremendous opportunity for career growth and exposure to innovative projects.

Job Type & Location

This is a Contract to Hire position based out of Broomfield, CO.

Pay and Benefits

The pay range for this position is $33.90 - $48.56/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Broomfield,CO.

Application Deadline

This position is anticipated to close on Jan 26, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.