Duration of this project: 2 years.

Project Overview:

We are leading an exciting multisite collaboration to develop an innovative decentralized molecular diagnostic test platform for infectious diseases. This project is focused on creating a user-friendly diagnostic device that provides users with results in just 30 minutes, enabling rapid treatment decisions and improved public health outcomes. The platform will undergo rigorous clinical studies to validate both the clinical performance and usability of the device. Our goal is to obtain FDA marketing authorization and ultimately empower users with actionable health information while expanding access to testing.

Position Overview:
We are seeking a Program Manager to oversee and guide the successful development of this groundbreaking at-home diagnostic test platform. In this role, you will be responsible for managing the overall program, ensuring that all project goals, timelines, and budgets are met. You will lead a cross-functional team, working closely with regulatory, quality, manufacturing, and business functions to deliver a commercially viable product.

Key Responsibilities:
Project Planning & Execution: Develop clear project scopes and objectives, identifying all relevant stakeholders and ensuring technical feasibility. Create a detailed project plan to track progress and manage changes in project scope, schedule, and costs.
Team Leadership: Lead and manage a cross-functional project team. Schedule, coach, and counsel team members to ensure project success.
Cross-functional Collaboration: Work closely with key departments including Regulatory, Quality, Manufacturing, and Business functions to ensure smooth project execution.
Budget & Schedule Management: Ensure that all projects are delivered on-time, within scope, and within budget. Proactively manage project risks, resources, and timelines.
Documentation & Reporting: Maintain comprehensive project documentation and ensure regular communication of project status, risks, and mitigation strategies to stakeholders.
Regulatory & Compliance: Ensure that the program aligns with all necessary regulatory requirements, including those for FDA approval, and guide the team through clinical trials and usability studies.

Qualifications:
Experience: Minimum of 5 years of experience leading commercial product development programs, with at least 3 years of experience in global, cross-functional project teams, preferably in the medical device or IVD industry.
Project Management Skills: Proficient in project management principles, including resource allocation, cost estimation, and risk analysis. Certification in project management (e.g., PMP) is preferred.
Agile Experience: Proven experience leading software development projects using Agile methodologies.
Leadership & Communication: Strong leadership abilities with a proactive, collaborative, and process-oriented approach. Excellent written and verbal communication skills in English. Ability to negotiate effectively and manage complex stakeholder relationships.

Preferred Skills:
Familiarity with FDA regulatory processes for medical devices and in vitro diagnostics.
Experience in molecular diagnostics or at-home health technologies.
Strong understanding of clinical studies and usability testing for non-professional users.

Why Join Us?

Work on a transformative project with the potential to improve global health outcomes.
Be part of a collaborative, innovative, and fast-paced environment.
Competitive compensation and benefits.
Opportunities for professional development and growth within a cutting-edge field.

If you are a motivated, experienced leader with a passion for advancing medical technologies, we encourage you to apply and help us drive this project to success.