Clinical Development Scientist

📋 Description

• • Shape the future of infectious-disease diagnostics by designing and executing high-impact clinical studies that will directly influence how more than 1,000 pathogens are detected from a single blood draw. Your protocols will become the evidentiary backbone that regulators, physicians, and payers rely on to adopt Karius’ groundbreaking microbial cell-free DNA platform.
• • Own end-to-end study architecture—from protocol concept and statistical analysis plans to final clinical study reports—while collaborating daily with cross-functional leaders in Medical Affairs, Biostatistics, Regulatory, Product, and Commercial. You will translate complex molecular data into clear clinical narratives that accelerate regulatory submissions and reimbursement decisions.
• • Drive rigorous literature reviews and secondary data analyses to identify evidence gaps, justify endpoints, and benchmark performance against current standards of care. Your insights will inform go/no-go decisions for new product indications and guide evidence-generation strategies across multiple pipeline assets.
• • Partner with external Key Opinion Leaders, Principal Investigators, and physician advisory boards to co-create study designs that answer the most pressing clinical questions. You will present data at major medical conferences and publish in peer-reviewed journals, establishing Karius as a thought leader in molecular infectious-disease diagnostics.
• • Lead data-interpretation sessions that convert raw genomic and clinical datasets into actionable insights. You will triangulate microbial cell-free DNA findings with patient outcomes to uncover novel biomarkers and refine diagnostic algorithms, directly impacting patient care and reducing time-to-appropriate therapy.
• • Ensure flawless compliance with FDA, GCP, and ICH guidelines by authoring SOPs, work instructions, and quality-control checklists. You will serve as the clinical point of contact during regulatory inspections and notified-body audits, confidently defending study methodology and data integrity.
• • Manage multiple concurrent studies across diverse patient populations (immunocompromised, ICU, oncology, transplant) while meeting aggressive timelines. You will proactively identify risks, develop mitigation plans, and communicate status to executive leadership in a fast-paced, high-growth startup environment.
• • Translate study results into compelling scientific content—abstracts, posters, slide decks, and white papers—that empowers the Commercial team to engage hospital administrators, laboratory directors, and payers. Your storytelling will bridge cutting-edge science and real-world clinical adoption.
• • Contribute to continuous improvement initiatives by leveraging lessons learned from each study to refine processes, templates, and analytics tools. You will mentor junior scientists and foster a culture of scientific excellence, ensuring Karius remains at the forefront of precision infectious-disease diagnostics.
• • Travel up to 25 % to academic medical centers, investigator meetings, and global conferences, building relationships that extend Karius’ reach and influence. You will return with fresh insights that shape next-generation study designs and strategic partnerships.