Director, Product – Genomic Solutions
GeneDxAbout the role
Summary
GeneDx, a global leader in genomic diagnostics, is seeking an experienced Director of Product to lead our Genomic Solutions product portfolio, overseeing the full end-to-end lifecycle of diverse genomic and molecular diagnostic test offerings. This leader will own the vision, strategy, and execution roadmap for developing, launching, scaling, and optimizing test products that drive clinical impact and operational excellence across the rare disease landscape.
This includes product strategy from early research and development through validation, regulatory planning, commercialization, performance optimization, and ongoing lifecycle management. The ideal candidate will balance scientific rigor, user-centered design, and market opportunity to deliver innovative diagnostic solutions that meet the needs of clinicians, labs, and patients affected by rare disease.
Job Responsibilities
- Own and evolve the product strategy and roadmap for rare disease diagnostic tests across their full lifecycle—from concept through commercialization and post-market optimization.
- Lead cross-functional collaboration with stakeholders including R&D, Clinical Affairs, Regulatory, Lab Operations, Commercial, Bioinformatics, and Engineering to bring diagnostic solutions to market efficiently and compliantly.
- Define and prioritize scalable, high-impact initiatives that improve test performance, clinical utility, market fit, and operational efficiency.
- Guide the development and launch of new tests or panels aligned with unmet clinical needs, scientific innovation, and business objectives.
- Lead and develop a team of product managers focused on different phases of the diagnostic product lifecycle.
- Use data and insights—scientific, operational, market-based—to inform prioritization, evaluate test performance, and guide product enhancements.
- Partner with Medical Affairs, Marketing, and Commercial teams to support go-to-market strategy, customer education, and ongoing product adoption.
- Ensure all products meet applicable regulatory, quality, and compliance standards (e.g., CLIA, CAP, FDA) while delivering clinical value and user trust.
- Maintain a deep understanding of the rare disease landscape, including evolving guidelines, reimbursement dynamics, and competitive offerings.
- Represent the voice of the customer—clinicians, laboratories, and internal stakeholders—to inform product requirements and ensure alignment across use cases.
People Manager
- Yes
Education, Experience, and Skills
- 8+ years of product management, lifecycle management, or diagnostic development experience in healthcare, diagnostics, or life sciences, including 3+ years leading product teams.
- Strong track record managing regulated diagnostic products, ideally including genomic or rare disease-focused test offerings.
- Demonstrated success leading cross-functional collaboration with R&D, Regulatory, Lab Operations, Engineering, and Commercial functions.
- Deep understanding of diagnostic product development and lifecycle processes including validation, regulatory strategy, clinical utility assessment, and commercialization.
- Familiarity with CLIA/CAP, LDT, and/or FDA-regulated environments and quality management systems.
- Strategic mindset and detail-oriented execution with the ability to balance scientific, operational, and market drivers.
- Strong analytical skills and ability to use data to inform decision-making and measure success.
- Excellent communication skills with the ability to engage technical and non-technical stakeholders across scientific, operational, and business domains.
- Empathy for the rare disease community and a passion for delivering impactful solutions that advance clinical care and diagnosis.
- Bachelor’s degree in life sciences, bioengineering, or related field required; advanced degree (MBA, MS, PhD) preferred.
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Science - Minded, Patient - Focused.
At GeneDx, we create, follow, and are informed by cutting-edge science. With over 20 years of expertise in diagnosing rare disorders and diseases, and pioneering work in the identification of new disease-causing genes, our commitment to genetic disease detection, discovery, and diagnosis is based on sound science and is focused on enhancing patient care.
Experts in what matters most.
With hundreds of genetic counselors, MD/PhD scientists, and clinical and molecular genomics specialists on staff, we ar
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