VP, Assay Development

Durham, NC
R&D /
Full-Time /
On-site
Based in Durham, North Carolina, Xilis, Inc. is a biotechnology company developing a precision oncology platform that guides treatment decisions for oncologists to improve cancer care outcomes for patients and supports drug discovery and development for pharmaceutical companies. Xilis’ proprietary MicroOrganoSpheres (MOS) are miniature patient tumors that capture the full microenvironment and heterogeneity and provide an automated and scalable solution. Using MOS, high-throughput automation, and AI-driven algorithms, Xilis is developing a Xilis Response Score™ for the clinic, enabling oncologists to make informed and timely treatment decisions. Additionally, the MOS technology is speeding up development and clinical trials of cancer drugs by enabling analysis of authentic tumor microenvironments, high-throughput preclinical modeling and clinical patient selection capabilities.
We are supported in this mission by top Silicon Valley, New York and international venture firms that are leaders in the healthcare space and have invested in top precision medicine companies including Foundation Medicine and Guardant Health.

Role
As the Vice President of Assay Development, you will report directly into the CEO of Xilis, Inc. This is an exceptional opportunity to lead a talented team of scientists and research associates, driving the development of novel and high-impact molecular assay products and workflows. You will build the assays that serve as the foundation of the Xilis MicroOrganoSphere (MOS) platform, collaborating with cross-functional teams, and ensuring our products meet the highest standards of quality, accuracy, and performance. You will play a strategic role in setting and achieving the scientific goals of the organization, driving the scientific vision, and providing crucial leadership and expertise across portfolio management, research, and development.
In addition to driving close internal collaboration across teams, you will collaborate with external partners including KOLs and pharma/biotech executives.
This role will be a good fit for a highly motivated dynamic, hands-on individual who understands what it takes to succeed in a startup environment and to lead and expand an incredibly talented team of scientists.  

Key Responsibilities:
Strategic Leadership: Develop and implement a comprehensive assay development strategy aligned with the company's mission and objectives. Set clear goals and milestones for the assay development team.

Team Management: Manage a diverse and high-performing team of scientists, research associates, and project managers. Foster a collaborative and innovative work culture.

R&D Pipeline Management: Oversee the development of molecular assays and testing platforms from concept to market release, ensuring projects are executed on time and within budget. Actively review and adjust priorities, programs, and decisions to optimize delivery against the most value-generating aspects of Xilis’ programs.

Innovation and Technology Assessment: Stay current with the latest developments in assay technologies and identify opportunities for innovation and improvement in our product portfolio.

Regulatory Compliance: Ensure that all assay development activities adhere to relevant regulatory standards and guidelines, including but not limited to FDA, ISO, and CLIA.

Cross-functional Collaboration: Collaborate closely with other departments, including Technology Platform, Operations, Quality, Business and Clinical Development to ensure seamless product development and launch.

Resource Allocation: Manage budgets, resources, and external partnerships to maximize the efficiency and effectiveness of the assay development process.

Quality Control and Assurance: Implement and oversee quality control measures to ensure that all developed assays meet the highest standards of accuracy and reliability.

Data-driven Product Development: Work with technology and data science teams to generate robust datasets, and interpret and make data-driven decisions to guide product development.

Intellectual Property Management: Ensure the protection of intellectual property and the development of a strong patent portfolio.

Qualifications

    • Ph.D. in a relevant field (e.g., Molecular Biology, Biochemistry, Biotechnology), with a minimum of 10 years of experience in assay development.
    • Proven track record of successfully leading teams in the development and commercialization of molecular assays or related products.
    • Proven track record in building and managing teams of highly skilled scientists and managers of various levels of experience.
    • A deep knowledge of cancer biology and immune-oncology and drug development across different modalities – small molecules, biologics, gene and cell therapy.
    • Experience with organoid-based models and primary patient-derived models is strongly preferred.
    • Experience with cutting-edge technologies, including PCR, NGS, immunoassays, microscopy and related methodologies.
    • In-depth knowledge of the various scientific and technical disciplines (and their integration) related to evaluating and advancing platform and therapeutic development.
    • Experience leading and working collaboratively on cross-functional project teams.
    • Excellent leadership and interpersonal skills, with the ability to communicate complex scientific concepts effectively.
    • Strategic thinker with a passion for innovation and a commitment to staying at the forefront of scientific advancements.
    • Willingness to lead, act as a player-coach and do what is necessary to meet project and corporate goals.
Xilis was created when its three founders — an engineer, a physician, and a biologist — decided to come together and commercialize their technology to transform cancer care. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We do not discriminate on the basis of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. Furthermore, even if your work experience isn't perfectly aligned with what we've described above, if you're excited about what we're building then we want to talk to you!
Xilis offers comprehensive health, vision, dental & retirement plans, and unlimited PTO. We are a remote-friendly team: our headquarters are in Durham, North Carolina, but we have team members across the US (and beyond!).