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 1000’s of biomarkers to accelerate clinical trials, discovering new microbes, and reducing patient suffering worldwide.
Biological materials are the foundation for research, development and validation of clinical products and their availability is often a rate limiting step in product and clinical development. In this role, the Sr. Manager, Biospecimen Acquisition will be a critical member of the Karius Biospecimen Team and is responsible for leading the planning and acquisition of biological materials, and associated data to facilitate and advance development activities across a portfolio of projects that applies Karius’ novel diagnostic technology within specific clinical indication(s). This is a part-time position.
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: Director, Clinical Operations
Location: Redwood City, CA
• Effectively interfaces with multiple internal stakeholders to understand sample requirements and specifications to derive a sample acquisition plan in support of product and clinical development.
• Responsible for building timelines for completion of any activities related to sample acquisition within supported projects and deliverables met per commitment.
• Develops Standard Operating Procedures for biospecimen acquisition in collaboration with other members of the Karius Biospecimen Team.
• Develops sample collection protocols, negotiates collection study contracts, clinical data use agreements, facilitates purchase requisitions, and collaborates with partners to acquire biological materials of interest, in compliance with Good Clinical Practices, Good Laboratory Practices and Quality standards.
• Maintains legal, regulatory, and ethics documentation surrounding sample acquisition.
• Develop and adhere to sample acquisition performance metrics.
Develops and maintains strategic partnerships with external vendors and CROs to provide a portfolio of agile biological material solutions to Karius.
• Direct oversight of CROs for sample collection protocols.
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 5-10%. International travel may be required per business needs.
Work is generally performed in an office (on-site or remote). Subject to extended periods of sitting and/or standing, computer work and moderate noise levels.
• Bachelor’s Degree in scientific or health related field or equivalent years of experience.
• 7+ years Biospecimen Management experience required, including relevant sample processing and Clinical Research experience.
• Experience with project, vendor, contract, and clinical research staff management.
• Advanced knowledge of Good Clinical Practice (GCP) and current knowledge of FDA regulations of clinical trial regulation is expected.
• Experience with Institutional Review Board (IRB) preparations and submission is required.
• Experience writing, reviewing and editing sample collection protocols.
• Demonstrate ability to perform vendor qualifications.
• Valid driver’s license.
• Must be an excellent communicator and able to summarize key findings, risks in a succinct manner.
• Ability to anticipate and identify potential roadblocks to meeting goals and identify corrective actions.
• Display a high level of commitment and professionalism and is truly passionate about being on the cutting edge of science and generating the appropriate clinical evidence.
• Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, external vendors and CROs.
• Ability to work independently, collaboratively and manage deadlines.
• Exemplary project management skills with the ability to build schedules and mitigate against timeline delays.
• Has curiosity and is passionate about having an impact on patient’s lives.
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.