Program Director

AOA Dx is seeking an experienced and strategic Program Director / Project Leader to drive the development of our next-generation in vitro diagnostic (IVD) product from concept to commercialization. This individual will lead a cross-functional team spanning R&D, manufacturing, quality, regulatory, clinical, and marketing/commercial functions to ensure seamless integration across all phases of product development. This role requires a strong background in diagnostics, program leadership, and product development, as well as a deep understanding of the IVD regulatory landscape. The ideal candidate will have 8-15 years of experience in leading complex product development programs within the biotech, diagnostics, or medical device industries.

Responsibilities:

Product Development Leadership

• Lead the cross-functional efforts to develop an IVD product, ensuring strategic alignment across R&D, project management, clinical, regulatory, quality, manufacturing and commercial functions
• Drive the team to success through the end-to-end development process, from feasibility through design verification/validation and regulatory submission to market launch
• Lead the team through the program roadmap, milestones, and critical dependencies, ensuring successful execution against corporate goals, mitigation of risks, and pivoting when necessary to modified plans
• Partner with Sr. Project Manager to maintain updated and transparent cross-functional product plans
• Cross-Functional Team Leadership & Execution
• Facilitate a high-functioning, cross-disciplinary team comprising R&D, Project management, manufacturing, quality, regulatory, clinical, and commercial stakeholders
• Lead team meetings, focusing on tracking progress, managing risks, and ensuring timely resolution of technical and operational challenges
• Align program priorities with business objectives and work closely with executive leadership to ensure visibility into progress and key decision points
• Ensure product requirements are clear and being met, partnering with quality, R&D, commercial and project management

Regulatory & Clinical Strategy Alignment

• Partner with regulatory and clinical teams to ensure product development aligns with FDA, IVDR, and other global regulatory requirements
• Ensure plans are aligned with R&D deliverables and design controls requirements
• Oversee the integration of clinical evidence generation strategies into the development plan to support regulatory approval and commercialization
• Ensure collaboration with commercial team on reimbursement strategies and planned milestones

Manufacturing, Quality, and Commercial Readiness

• Work with R&D, manufacturing, quality and supply chain teams to ensure product scalability, robustness, and alignment with commercial strategy
• Collaborate with quality teams to maintain compliance with industry standards and regulatory requirements
• Support go-to-market planning, working closely with commercial and marketing teams to ensure successful product launch

Risk Management & Process Optimization

• Identify and mitigate technical, operational, and regulatory risks throughout the development process
• Continuously optimize program execution by implementing best practices, structured workflows, and data-driven decision-making

Qualifications:

• 8-15 years of experience in IVD, diagnostics, medical devices, or biotech program leadership. Proven track record of leading cross-functional teams in a regulated product development environment
• Strong understanding of IVD product development, including R&D, clinical validation, regulatory submission, and commercialization
• Experience managing program budgets, timelines, and risk assessments. Excellent communication, stakeholder management, and leadership skills

Preferred Qualifications:

• Experience with FDA, IVDR, and global regulatory pathways for IVD products
• Knowledge of design control, quality systems (ISO 13485), and manufacturing scale-up. Background in molecular diagnostics, proteomics, or other emerging diagnostic technologies.

Location: Hybrid in Denver, CO

Salary and Benefits:

Salary range: $175,000 - $200,000 per year, commensurate with experience and qualifications.

AOA Dx offers competitive benefits, including unlimited PTO, group health, dental, and vision insurance, 100% employee sponsored life and disability benefits, monthly cell phone reimbursement, and a 401k plan with employer match.

How to Apply: To be considered for this role, please apply via LinkedIn or send your resume to careers@aoadx.com with “Program Director / Project Leader” in the subject line

AOA Dx is an equal opportunity employer and welcomes candidates from all backgrounds to apply. We foster an environment where all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation or expression, age, disability or veteran status or any other characteristics protected by law.