Remote Senior Clinical Development Scientist
Karius
π΅ $134k-$201k
πRemote - United States
Please let Karius know you found this job on JobsCollider. Thanks! π
Job highlights
Summary
Join Karius, a venture-backed life science startup, as a Senior Clinical Development Scientist to play a pivotal role in steering the clinical strategy that supports the companyβs diagnostic products. This role involves hands-on leadership and design of clinical trials, providing medical and/or scientific expertise, authoring written deliverables, and collaborating with cross-functional teams.
Requirements
- A Master's degree (in Public Health); a Ph.D. or MD is desired
- 5+ years professional experience in research & or diagnostic industry
- Proven ability to lead the design & execution of clinical studies
- Experience designing clinical studies to support both FDA approvals and CMS reimbursement
- 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
- 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
Responsibilities
- Hands-on leadership and design of clinical trials
- Provide medical and/or scientific expertise to the project team during the lifecycle of the 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 leadership on grant requests for support of investigator-initiated 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
Benefits
- Health insurance
- Retirement benefits
- Paid time off
- Remote work, flexible hours
Share this job:
Disclaimer: Please check that the job is real before you apply. Applying might take you to another website that we don't own. Please be aware that any actions taken during the application process are solely your responsibility, and we bear no responsibility for any outcomes.
Similar Remote Jobs
- π°$146k-$195kπUnited States
- π°$114k-$164kπWorldwide
- π°$250k-$285kπWorldwide
- πWorldwide
- π°$145k-$197kπUnited States
- π°$165k-$207kπUnited States
- π°$117k-$162kπUnited States
- π°$260k-$350kπWorldwide
- πUnited States
Please let Karius know you found this job on JobsCollider. Thanks! π