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Director, Clinical Operations
Redwood City, CA
Job Description
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
We are looking for an experienced Director, Clinical Operations to lead the overall execution of clinical programs and to build a high-quality clinical operations team to support evidence generation, new product development, and regulatory submissions. The Director, Clinical Operations will report to the VP, Clinical Affairs and will play both a key hands-on and management role in the planning and execution of all clinical operations programs and studies, managing personnel and clinical activities across the organization. The successful candidate will make or recommend operational strategies in support of achieving clinical program objectives and be responsible for management of clinical trial execution, including managing clinical sites, vendors, and collaborating with internal and external stakeholders. The successful candidate will be accountable for building and managing a high-quality, compliant, and scalable Clinical Operations team.
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: VP, Clinical Affairs
Location: Redwood City, CA or Remote
Primary Responsibilities:
* Develop and execute strategic plans for Clinical Operations in alignment with company goals and objectives.
* Lead the planning, implementation, and execution of diagnostic clinical trials from initiation to completion. Ensure adherence to timelines and budgets while maintaining compliance with quality and regulatory requirements.
* Responsible for developing study-related plans and documents including informed consent forms, case report forms, and provides input to clinical study protocols and clinical study reports.
* Oversee data collection, monitoring, and analysis activities to ensure data integrity and accuracy. Review clinical trial data, identify trends, and contribute to data-driven decision-making.
* Mentor and develop Clinical Operations team members, providing guidance, training, and support to foster professional growth and excellence in performance.
* Manage all clinical trial budgets, resource allocation, and forecasting. * Monitor expenses, track project milestones, and optimize resource utilization to meet project goals within budgetary constraints.
* Partner closely with the medical and clinical teams to plan and execute clinical studies to produce high-quality data for publications while satisfying regulatory requirements.
* Maintain an overview of status, issues, risks and proactively communicates progress, issues, changes, or risk mitigation strategies that may impact timelines and costs of the program to all stakeholders
* Ensure adherence to ICH GCP and applicable guidelines and regulations.
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%.
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
* Minimum Bachelor's in scientific or clinical field. Medical background and advanced degree strongly preferred.
* 10+ years of experience leading Clinical Operations in a diagnostic, medical device or pharmaceutical company with successful track record of well-executed clinical studies with Bachelor's degree, 8+ years of experience with M.S. and PhD.
* Experience with infectious disease diagnostic clinical trials, preferred.
* Strong personnel management experience and leading teams of >5 direct reports that include Clinical Research Associates, Clinical Trial Managers, and Clinical Data Managers.
* Strong project management experience, PMP certification a plus.
* Experience running multi-site clinical trials intended for regulatory submission.
* Working experience with an electronic data capture system (Medrio preferred), CTMS and eTMF systems (Veeva preferred).
* In depth understanding of human subject research, ICH/GCP guidelines and knowledge of FDA/CMS regulations.
Personal Qualifications
* Demonstrated ability to thrive in cross-functional environment focused on company-level goals, interact across multiple disciplines, be flexible, and handle multiple tasks to meet deadlines while delivering high-quality work in a dynamic environment.
* Demonstrated ability to manage outside consultants, vendors, and contractors
* Thinker and doer with the ability to formulate, develop, and execute clinical strategies.
* Outstanding scientific written and oral communication skills as well as interpersonal, 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.
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 recruiting@kariusdx.com and we will accommodate qualified individuals with disabilities.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Salary and Benefits
$178,087 - $267,116 a year
Required Education
Bachelor's Degree
Required Experience
10+ years
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