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.

• 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
  

Preferred:

• 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 demonstrated leadership experience

• You have demonstrated experience in the AI/ML/Computational space

• 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.
  

This is an on-site position based in Santa Clara CA or Pleasanton CA.
Relocation benefits are not being offered for this role.

The expected salary range for this position based on the primary location of Santa Clara CA is $221500 - $411700. Actual pay will be determined based on experience qualifications geographic location and other job-related factors permitted by law. We encourage all qualified applicants to apply. The roles level (& title) may be adjusted based on experience and qualifications.

A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.

Benefits

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.

If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.