Precede Biosciences

QA Engineer

• Design and develop computational approaches for characterizing the performance of existing and new epigenomic tests.
• Define and implement metrics and analyses to assess NGS and epigenomic data quality to enable coordinated optimization of assay and diagnostic performance.
• Lead the computational execution of verification and validation protocols, statistical analysis plans (SAPs), and performance summary reports to meet FDA evidentiary standards.
• Translate complex computational results into clear, well-organized regulatory documentation for FDA submissions.
• Stay current on FDA guidance for IVDs, companion diagnostics, and evolving LDT oversight to actively inform study design decisions.
• Develop and apply statistical methods for diagnostic characterization, including LOD/LOQ, reproducibility, thresholding, gaurdbanding, and clinical utility endpoints.
• Support and optimize robust, reproducible analysis pipelines—ensuring code traceability and standardization from raw NGS data through regulatory-grade outputs.
• Identify and systematically address sources of variability, bias, and technical confounding across the computational workflow.
• Partner closely with laboratory development, clinical operations, and regulatory affairs to ensure absolute scientific and regulatory alignment across programs.
• Contribute to clinical study design—including sample size calculations, endpoint selection, and pre-specified SAPs using data-driven insights from analytical validation pilots.

Associate Director – Computational Test Development

Project Manager

• Partner with early development leads and biomarker development leads to build and maintain comprehensive project plans with clear milestones and deliverables.
• Own and manage integrated program timelines across multiple concurrent programs, ensuring milestones are clearly defined, dependencies are mapped, and critical path activities are actively managed
• Track project progress, centralize resource planning and prioritization across the program.
• Establish and maintain a centralized program tracking system that provides real-time visibility into program status across the portfolio
• Prepare and deliver regular program status updates, executive dashboards, and portfolio reviews for senior leadership
• Serve as the primary point of coordination across R&D, Clinical Affairs, Regulatory, Quality, Commercial, and Operations teams to ensure alignment on program priorities and deliverables
• Facilitate prioritization reviews and decision-making forums, ensuring the right stakeholders are engaged to make prioritization decisions.
• Proactively identify risks, issues, and resource constraints across programs and drive resolution through structured problem-solving and escalation as needed
• Coordinate cross-functional team meetings, author meeting agendas and minutes, and hold teams accountable to action items and commitments
• Support the development and continuous improvement of project management processes, tools, and templates for project and program management.
• Help define and enforce project prioritization criteria and concept/feasibility development phase definitions across molecular diagnostic and companion diagnostic program types
• Drive adoption of project management best practices across the development organization, coaching functional leads on planning and accountability tools

Associate Director – Computational Test Development

Associate Director/Director, Project Management