Company
Biotech
AssociateDirector/Director,ComputationalTestDevelopment
Neural analysis suggests this role is
optimal for Director candidates.
“Associate Director/Director, Computational Test Development. Skills: Computational biology, Bioinformatics, Biostatistics, NGS analysis. Design computational approaches. Develop computational approaches”
Industry & Context.
Address sources of variability; Address sources of bias; Address sources of confounding
What They're Looking For.
Must Have
PhD in computational biology, 4–9 years of industry experience, Proven track record working under a formal Quality Management System, Hands-on experience contributing to regulatory submissions, Solid grasp of analytical validation frameworks, Fluency in R, Fluency in Python, Startup mindset
Nice to Have
Direct experience with advanced NGS modalities, Experience in regulated diagnostics, Experience in liquid biopsy, Experience in IVD development, Experience within a fast-paced, cross-functional R&D environment
What You'll Do.
Design computational approaches
Develop computational approaches
Assess NGS data quality
Assess epigenomic data quality
Lead computational execution
Lead verification protocols
Lead validation protocols
Lead statistical analysis plans
Lead performance summary reports
Translate computational results
Develop statistical methods
Apply statistical methods
Support analysis pipelines
Optimize analysis pipelines
Address sources of variability
Address sources of bias
Address sources of confounding
Partner with laboratory development
Partner with clinical operations
Partner with regulatory affairs
Contribute to clinical study design
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Laboratory development; Clinical operations; Regulatory affairs
Communication Scope
Present analytical validation strategies; Defend analytical validation strategies; Regulatory documentation
Process & Methodology
Statistical analysis plans
Full Job Description
## 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 Analytical Validation & Regulatory Execution 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 o
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