Senior Director, Assay Development

Redwood City, CA
Research & Development – Molecular Biology /
Full-time /
On-site
About Karius
Karius is a venture-backed life science startup that is transforming the way pathogens and other microbes are observed throughout the body.  By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to the microbial landscape to accelerate biomarker discovery and clinical trials, discover novel microbes, to ultimately reduce patient suffering worldwide.

Position Summary
The Senior Director, Assay Development leads product technology development activities including IVD development, automation of NGS protocols, and in-house reagent manufacturing. The successful candidate will build and manage a team of scientists to ensure product performance by executing Karius’ product development process, incorporating IVD guidelines and design approaches. They will provide leadership in optimal strategy for experimental approach, verification, validation, and technical transfer to CLIA lab and external partners. The successful candidate will collaborate with Karius’s technical, clinical, product, quality, and production teams.

Why Should You Join Us?
Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.
 
Reports to:    Chief Scientific Officer
*This position is not open to agency support at this time. Agencies, please contact recruiting@kariusdx.com and not the hiring manager for inquiries.
 
Location:  Redwood City, CA
 
Primary Responsibilities
•  Leading diagnostic test maturation through the development stages, including the design and execution of all non-clinical studies required by the FDA and other regulatory agencies.
•  Manage the execution of large-scale biotechnology and diagnostic product development initiatives for on-time, on-budget achievement of milestones.
•  Serve as the technical lead on product development activities, many of which will be under design control. 
•  Provide technical expertise and leadership in product development planning, experimental approach decisions, experimental execution, data analysis, specification verification, analytical validation design, and quality control approaches.
•  Ensure product performance by employing proven product development practices.
•  Make fundamental scientific contributions toward producing robust products.
•  Oversee the design, development, optimization, and validation of diagnostic assays.
•  Ensure assays are robust, reproducible, and meet clinical and regulatory standards.
•  Develop and implement protocols for assay development, including sample preparation, data analysis, and quality control.
•  Develop and execute a strategic plan for assay development that aligns with company goals and objectives.
•  Identify and prioritize key projects, ensuring timely and successful completion.
•  Stay current with industry trends and emerging technologies to maintain a competitive edge.
•  Perform data analysis with advanced analytical and statistical tools.
•  Clearly communicate results with colleagues and R&D management.
•  Set clear goals, provide regular feedback and support professional development, and supervise the activities of direct reports or team members.
•  Work closely with cross-functional teams, including R&D, clinical, and regulatory, to ensure seamless integration of assay development efforts.
•  Communicate project status, results, and challenges to senior management and other stakeholders.
•  Represent the assay development team in internal and external meetings, presentations., 
 
What’s Fun About the Job?
Karius is operating at the edge of what is now known to be possible in infectious disease diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.
 
Travel:      Travel required up to 5%.
 
Physical Requirements
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, lab or clinical environment.
 
Position Requirements
•  Ph.D. in molecular biology or related field
•  10+ years of post Ph.D. biotech industry experience
•  Prior experience in NGS-based IVD product development required
•  Prior experience developing sample preparation instruments required
•  4+ years of experience managing a research or development team
 
Personal Qualifications
•  Demonstrated ability to work in a fast-paced, life sciences company environment, interact across multiple disciplines, and manage outside consultants, vendors and contractors
•  Ability to formulate, develop, and execute product development strategies.
•  Excellent interpersonal, communication, negotiation, organizational, and project management skills.
•  Demonstrated ability to identify, motivate, develop, and evaluate personnel to ensure the efficient operation of the function including hiring, performance management, and related duties.
•  Proven track record of successful assay development and validation in a clinical or diagnostic setting.
•  Strong understanding of molecular biology techniques, nucleic acid extraction, PCR, NGS, and other relevant technologies.
•  Experience with regulatory requirements and standards for diagnostic assays (e.g., CLIA, CAP, FDA).
•  Excellent leadership, communication, and interpersonal skills.
•  Ability to think strategically and manage multiple projects simultaneously.

At Karius, we value a diverse and inclusive workplace and provide equal employment opportunity for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company.  All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at recruiting@kariusdx.com and we will accommodate qualified individuals with disabilities. 
$206,469 - $309,703 a year