Chapter Lead, Head of SBX Assays

Roche•Pleasanton, CA

23h•Onsite

About The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position As Chapter Lead and Head of SBX Assays, you will drive the clinical translation of cutting-edge technology into RUO and regulated products that 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 early 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).

Requirements

Education Level: Ph.D. or MD/PhD Molecular Biology, Oncology, Genetics, or related fields
Experience : 10+ years in the molecular diagnostics industry. Proven track record of launching one or more NGS-based clinical assays (IVD or high-complexity LDT).
Management experience of large multidisciplinary scientific teams for 7+ years
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 Experienc e: 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 and influence and guide senior functional experts who do not report to you directly.
Scientific Presence : A sustained record of innovation, evidenced by high-impact peer-reviewed publications or patents in ctDNA, methylation, or early detection.
Business acumen : Experience in portfolio prioritization and resource allocation within a matrixed R&D organization
Travel Requirements : ability to travel 15 - 20% of time to fulfill various business needs, including global oncology conferences and customer meetings

Nice To Haves

You have demonstrated strong interpersonal and communication skills with the ability to communicate complex technical knowledge in a clear and understandable manner to a multidisciplinary team.
You have strong problem-solving skills with the ability to work independently
You have excellent written and verbal communication skills to effectively influence cross-functional stakeholders.

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 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 and clinical validation studies (LoD, LoB, Precision) that meet FDA/PMA standards for Breakthrough Device designations.
Evidence Generation & KOL Engagement : Help define the clinical evidence strategies 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 "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.
Champion Our Culture : Foster a "Culture of Rigor" that balances rapid prototyping with the disciplined documentation required for regulated medical products.