Chapter Lead, Head of SBX Assays

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The Position

As Chapter Lead, Head of SBX Assays, you will drive the clinical translation of cutting-edge technology into RUO and regulated products the redefine the standard of care in precision oncology and genetics. You will provide strategic and technical leadership to define the next generation of oncology diagnostics - ranging from multi-cancer detection to ultra-sensitive MRD monitoring.

You will lead the end-to-end evolution of novel clinical solutions, bridging the gap between novel workflow tools and high-throughput commercial implementation. Your leadership will ensure that our assays are not just innovative, but are robust, scalable, and clinically validated to meet the most stringent regulatory standards (PMA/IVD).

Key Responsibilities

• Oncology Product Roadmap: Partner with Executive Leadership and Business teams to identify high-value clinical unmet needs and translate them into a multi-year technology roadmap.

• Strategic Execution: Drive end to end development of proprietary oncology assays, including defining performance requirements (LOD, sensitivity, specificity) that exceed current market standards..

• Product Realization & Scale: Oversee the critical transition of assays from R&D into a CLIA/CAP or IVD-regulated environment, ensuring manufacturability and operational scalability.

• Assay Innovation & De-risking: Implement and de-risk emerging technologies for use in clinical applications (e.g., epigenetics, fragmentomics, multi-omics).

• Regulatory: Partner with Regulatory and Quality teams to design analytical validation studies (LoD, LoB, Precision) that meet FDA/PMA standards for Breakthrough Device designations.

• Evidence Generation & KOL Engagement: Help define the clinical evidence strategy required for medical utility based on high-level scientific exchange with top-tier academic centers and biopharma partners.

• Bioinformatics Integration: Architect the interface between wet-lab chemistry and Computational Biology to optimize the "sample-to-variant" pipelines, focusing on digital error suppression and signal-to-noise optimization

• Operational Leadership: Drive 'Best-in-Class' technical standards across the organization, ensuring consistency in assay development methodologies and cross-functional alignment on technical KPIs

• Value Communication: Present scientific and clinical value propositions at webinars, workshops, or customer meetings.

• People & Culture: Foster a "Culture of Rigor" that balances rapid prototyping with the disciplined documentation required for regulated medical products.
   

Who You Are:
(Required)

• You have a PhD or MD/PhD in Molecular Biology, Oncology, Genetics (or related fields)

• You have 12 or more years in molecular diagnostics 

• You have a proven track record of launching one or more NGS-based clinical assays (IVD or high-complexity LDT)

• You have demonstrated experience managing large multidisciplinary scientific teams for 7+ years
   

You have the following knowledge, skills, and abilities:
 

• NGS Mastery: Deep expertise in library preparation (e.g., UMI tagging, hybrid capture) and their direct impact on clinical sensitivity and limit of detection (LOD).

• Clinical Vision: Comprehensive understanding of the "Cancer Continuum," including solid tumor profiling, hematological malignancies, and the nuances of liquid biopsy.

• Regulatory Experience: Proven track record of navigating the Design Control process (21 CFR 820) and launching at least one NGS-based clinical assay (IVD or high-complexity LDT).

• Technical Diplomacy: Exceptional ability to navigate complex stakeholder environments; influence and guide senior functional experts who do not directly report to you.

• Scientific Presence: A sustained record of innovation, evidenced by high-impact peer-reviewed publications or patents in ctDNA, methylation, or early detection