The Opportunity
We are seeking an Associate Director/Director-level computational scientist to drive the analytical and regulatory dimensions of diagnostic test development at Precede Biosciences. Reporting to the Senior Director of Computational Test Development, this role sits at the center of our effort to bring a novel epigenomics-based liquid biopsy platform from late-stage development through FDA regulatory submission.
You will lead the analytical strategy and bioinformatics infrastructure verification that underlies our validation programs. You will drive the interpretation of complex data, guide pipeline execution, and author critical regulatory documentation in close partnership with laboratory, clinical, and regulatory teams.
About Us
We are pioneering an advanced, minimally invasive, comprehensive epigenomics platform with the potential to profoundly impact the research and development of new medicines and the use of approved medicines in clinical practice across a number of conditions, including cancer. More information on our company and platform can be found on our company website and in our seminal publication in Nature Medicine.
We care deeply about creating a place where folks can do their best work from the start and have intentionally created an environment that is defined by purpose, teamwork, and excellence. This means nurturing team spirit, facing challenges together, and collaboratively solving complex problems, while also ensuring a strong focus on individual initiative, accountability, and delivery.
What You'll Bring
- PhD in computational biology, bioinformatics, biostatistics, or a closely related quantitative field. Direct experience with advanced NGS modalities (e.g., cell-free DNA, ChIP-Seq, or epigenomic signal processing) is highly preferred.
- 4–9 years of industry experience in regulated diagnostics, liquid biopsy, or IVD development, ideally within a fast-paced, cross-functional R&D environment.
- Proven track record working under a formal Quality Management System (ISO 13485, 21 CFR Part 820).
- Hands-on experience contributing to regulatory submissions (such as Pre-Subs, De Novo, or 510(k) tracks). Please describe your specific role and submission type in your cover letter or CV.
- Solid grasp of analytical validation frameworks, including CLSI EP guidelines, FDA IVD/CDx guidance, and CAP/CLIA requirements.
- Fluency in R and/or Python for robust statistical modeling, data analysis, and reproducible reporting.
- Strong communication skills with a demonstrated ability to present and defend analytical validation strategies to internal leadership, scientific advisors, and regulatory stakeholders.
- Startup mindset: You thrive when taking autonomous ownership of projects, remain adaptive under evolving information, and execute effectively in an entrepreneurial environment.
What You'll Do
- 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.
Analytical Validation & Regulatory Execution
Statistical & Bioinformatics Analysis
Cross-Functional Collaboration
Skills Required
- PhD in computational biology or bioinformatics
- 4-9 years of industry experience in regulated diagnostics
- Experience with regulatory submissions (Pre-Subs, De Novo, 510(k))
- Fluency in R and/or Python for data analysis
- Hands-on experience with NGS modalities
- Proven track record in Quality Management System (ISO 13485, 21 CFR Part 820)
What We Do
We've experienced the significant gaps in our collective ability, as a medical and research community, to access and understand disease-defining biology when it matters most. To address this, we've developed a simple blood test to uncover actionable disease-defining transcriptional biology. Our unique genome-wide platform profiles circulating chromatin and the DNA methylome to deliver resolution into the dynamic activity of individual genes and pathways in diseased tissues from just 1mL of plasma. By partnering with developers of new medicines and advancing our own diagnostic tests, we’re working towards a world where new medicine development efforts succeed more frequently, and where anyone can receive a minimally invasive diagnosis and treatment that’s precise to the biology of their disease.
