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Karius is a private life sciences company pioneering the use of microbial cell-free nucleic acid-based metagenomics to revolutionize diagnosis and management of infectious diseases, rapidly and efficiently advancing clinical evidence to accelerate technology adoption and reimbursement, and leveraging Karius’ technology platform to identify new biomarkers for infectious and non-infectious diseases. Using a routine blood sample the current Karius Test can rapidly and non-invasively identify and quantitate >1000 bacterial, DNA-based viral, fungal, and parasitic human pathogens as well as identify important antimicrobial resistance markers.
The Senior Director of Clinical Development provides leadership and individual contributions in conceptualization, design and execution of clinical studies to: 1) effectively support development and improvement of new Karius product features and new products; and 2) advance clinical evidence that accelerates adoption and reimbursement for Karius products. This work will be done while maintaining careful alignment and synergy with other Karius functional units (e.g., Medical Affairs, Product, and Commercial) and diverse outside stakeholders including regulatory authorities and key opinion leaders.
A successful applicant will rapidly gain an in-depth understanding of Karius technologies and products, and help to shape a portfolio of strategic, cost-effective and aligned clinical studies. These studies will address outpatient and inpatient use of Karius products and may include use of prospective and retrospective designs, observational and interventional methods, and registries and other real world data sources to generate clinical and economic evidence. This evidence needs to tangibly advance product features and product development as well as product adoption through mechanisms including but not limited to key opinion leadership support, guideline inclusion, regulatory approvals, and reimbursement.
This role involves a combination of both hands-on, individual contributions to clinical development projects, as well as leadership responsibilities providing clinical and scientific guidance and mentoring team members.
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: Vice President, Clinical Affairs
Location: Remote or Hybrid
• Hands-on design of clinical trials, including selecting appropriate study designs, endpoints, and patient populations to facilitate adoption, regulatory approval and/or reimbursement of the Karius Test for infectious disease indications.
• Provide medical and/or scientific expertise to the project team during the lifecycle of study.
• Author major written deliverables including, protocols, clinical study reports, regulatory submissions, original articles, abstracts, posters and presentation materials.
• Architect clinical evidence development strategy for Karius Test intended uses with executive team and aligned with company product strategy.
• Collaborate with the Clinical Operations team on execution and delivery of multiple concurrent clinical studies.
• Collaborate with Biostatistics to develop and execute study statistical analysis plans. Provide clinical guidance into future product development and enhancements.
• Provide medical leadership on grant requests for support of Investigator Initiated Studies.
• Guide and mentor junior team members and foster their professional growth. Provide leadership by example and support the development of a strong clinical affairs team.
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 10%.
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels.
• Doctoral-level degree in Medicine (MD or DO); an equivalent combination of education in Life Sciences (Ph.D.) and experience may be considered.
• 8+ years professional experience in a clinical setting or diagnostic industry focused on infectious disease, with at least 3 years in a leadership role.
• Proven ability to develop a clear roadmap for the clinical program, making critical decisions about trial design, endpoints and patient populations.
• Experience designing clinical studies to support both FDA approvals and CMS reimbursement. Specific experience designing trials to support breakthrough device submissions is a plus.
• Extensive experience in designing, planning, and executing clinical trials is essential. This involves knowledge of trial methodologies to support clinical validity and utility evidence generation for Laboratory Developed Tests and In Vitro Diagnostics. Cell-free DNA-based applications or similar applications is preferred.
• Successful design, execution, and publication of at least one multi-center prospective clinical study in infectious disease.
• Expertise in scientific and clinical data review and interpretation.
• Track-record of producing outstanding clinical study protocols, clinical study reports, publications and poster presentations.
• Project leadership and management skills.
• Strong commitment to ethics and compliance.
• Passionate, purpose-driven, and excited about Karius’s mission.
• Outstanding communication skills including public speaking, written communication, and interpersonal skills with an ability to communicate technical concepts with clarity and accuracy.
• Team player attitude with demonstrated ability to thrive in a cross-functional start up environment.
At Karius, we value a diverse and inclusive workplace and provide equal employment opportunities 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 [email protected] and we will accommodate qualified individuals with disabilities.