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Fractional Leadership & Executive Guidance

NextPhaseDx provides strategic and scientific leadership to help diagnostics teams navigate critical inflection points — from concept development to regulatory clearance and commercialization. We integrate executive-level oversight with hands-on technical insight to bridge science, strategy, and compliance.

 

As a small business prime experienced in SBIR and STTR programs, NextPhaseDx can lead collaborative research and development efforts — managing federal funding, subcontractors, and compliance to advance innovative diagnostics from concept to commercialization.

Our Experience

We bring decades of hands-on leadership across diagnostics R&D, quality systems, and regulatory strategy, ensuring your organization advances efficiently, compliantly, and investor-ready.

  • Fractional executive leadership (CSO, VP R&D, or Program Director) for start-ups and funded teams

  • SBIR/STTR program leadership and management — serving as prime awardee or supporting partner institutions

  • Translational strategy development to align R&D, validation, and regulatory milestones

  • Program and portfolio management under FDA design-control and QMSR frameworks

  • Representation during partner, investor, or regulatory interactions to strengthen credibility and communication

  • Mentorship and team development to build internal leadership and operational readiness

Whether your need is short-term leadership continuity or strategic direction through a growth phase, NextPhaseDx provides the executive insight to keep your diagnostics program on track — and built for long-term success.
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