Associate Director - Bioinformatics Product

Position Summary:

As an Associate Director of Bioinformatics Product you will lead the design, development, and delivery of innovative bioinformatics solutions for precision oncology. This role combines product leadership, software engineering oversight, and bioinformatics expertise to create compliant, high-impact products. The ideal candidate has 8+ years in NGS diagnostics and a proven track record of regulatory submissions with regulatory and reimbursement agencies. This is a remote position.

• Define, own and execute product vision, roadmap and measurable outcomes for bioinformatics and software platforms supporting NGS-based diagnostics.
• Provides strategic and validation oversight for algorithm development, partnering with scientific leads to define product strategies and validation methodologies.
• Drive feature prioritization and release planning aligned with clinical impact, technical feasibility, and regulatory requirements.
• Drive product software development life cycle (SDLC) in partnership with cross functional teams.
• Lead cross-functional teams including software engineers and bioinformatics scientists to deliver robust, scalable platforms.
• Oversee algorithm design, pipeline optimization, and integration of cloud-based infrastructure.
• Direct analytical validation studies for bioinformatics algorithms and clinical software.
• Apply biostatistical methods to ensure compliance with rigorous regulatory standards.
• Manage product submissions and approvals across CAP, CLIA, NYDoH, FDA standards.
• Oversee analytical validation for regulatory and reimbursement packages with a focus on product management, quality, and regulatory compliance.
• Support clinical and medical studies design and analytical review
• Ensure audit readiness and maintain documentation for all software and assay components.
• Incorporate multimodal biomarkers, AI/ML algorithms, and advanced analytics into product design.

• 8+ years in bioinformatics product management within an NGS diagnostic company.
• Proven leadership of software engineering and bioinformatics teams.
• Demonstrated success in regulatory submission of diagnostic products (CAP, CLIA, FDA, NYDoH, Mol Dx).
• Expertise in algorithm development, biostatistical validation, and clinical-grade software delivery.
• Experience developing products for oncology (Heme and solid tumor) is a requirement.
• Advanced degree (MSc/PhD) in Bioinformatics, Computational Biology, Computer Science, or related field.
• Experience with product design and development and successful analytical validation of products for FDA, regulatory agency approval and reimbursement by payers.
• Experience with cloud-based bioinformatics infrastructure and AI-driven analytics.
• Strategic thinker with the ability to balance innovation and regulatory rigor.
• Strong technical depth in software architecture, bioinformatics pipelines, and statistical validation.
• Skilled communicator who can influence technical and business teams.