Clinical Development Scientist

Redwood City, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 were 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 seeking a passionate Clinical Development Scientist who will be responsible for the design and execution of our clinical studies. By working closely with cross-functional teams you will develop study protocols analyze data and generate clinical evidence to support regulatory submissions.

The ideal candidate will have a strong background in clinical research and molecular diagnostics with a proven ability to drive study design & implementation in a fast-paced scientifically rigorous environment. This individual will collaborate closely with external stakeholders including key opinion leaders (KOLs) and Investigators. Provides support for clinical evidence discussions with regulatory agencies notified bodies and physician advisory boards. You will communicate across all levels of the organization and need to be able to develop a rapport with indirect or functional leaders to influence decision-making and facilitate change. You will be part of a cross-functional team that includes the medical clinical commercial and product teams as we build future products to solve some of the toughest problems in infectious diseases.

Why Should You Join Us

Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The companys 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: Sr. Vice President Clinical Affairs

Location: Redwood City CA (Hybrid) or Remote (USA)

Primary Responsibilities

Support the development of clinical protocols amendments case report forms and data analysis interpretation.

Conduct secondary research including literature reviews to support study design.

Assist in the preparation of study reports and other regulatory and/or reimbursement documents.

Collaborate with the trial operations team on execution and delivery of multiple clinical studies.

Collaborate with biostatistics to develop and execute study statistical analysis plans.

Ensure compliance with relevant regulations guidelines and SOPs.

Help manage study data and maintain documentation.

Participate in major written deliverables (e.g. protocols clinical study reports regulatory submissions original articles abstracts posters and presentation materials) in collaboration with Medical and Clinical Affairs team members.

Support the development of SOPs policies and work instructions as part of continuous improvement initiatives.

Actively participate in clinical study oversight including monitoring study progress ensuring compliance with regulatory requirements and addressing any clinical issues that arise.

Lead data interpretation sessions and assist in preparing clinical results for publication in peer-reviewed journals or conference presentations.

Support the creation of regulatory documentation and submissions to ensure compliance with FDA and other regulatory bodies.

Whats 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 dont suffice. You will get to see how much your work really matters.

Travel: Travel up to 25%.

Physical Requirements

Subject to extended periods of sitting and/or standing vision to monitor and moderate noise levels.

Position Requirements

A minimum of a Masters of Public Health Ph.D. or MD.

A minimum of 3-5 years of scientific/research background with experience in clinical research (preferably molecular diagnostics) conduct including methodology and statistics.

Experience in scientific and clinical data review and interpretation.

Project leadership and management skills.

Personal Qualifications

Strong medical writing experience effective verbal communication and presentation skills in technical/clinical applications and experience in the conduct of literature searches pertinent to clinical/medical research.

You possess knowledge of clinical research device development processes regulatory requirements and good clinical and data management practices

Demonstrated ability to thrive in a cross-functional environment focused on company-level goals.

Disclaimer

The above job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties responsibilities and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius.

Equal Opportunity Employer

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 individuals 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 emailprotected and we will accommodate qualified individuals with disabilities.

$106079 - $139229 a year

Required Experience:

About KariusKarius 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 were helping doctors quickly solve their most challenging cases providing industry p...