Sr. / Staff Clinical Development Scientist

Job Summary

Truvian is seeking a Senior/Staff Clinical Development Scientist to join our team. This is a hands-on role where you will drive strategic study designs, execution, analysis and reporting on studies to support critical development and V&V milestones while maintaining regulatory compliance and supporting regulatory submission of Truvian's automated diagnostic platform. Level will be determined by the candidate's experience and scope. You will work closely with R&D, Clinical, Biostatistics, Data Management, Regulatory, Quality and other cross-functional partners in a fast-paced, evolving environment.

What You Will Do

• Design well-controlled internal and external clinical studies and collaborate with internal teams to drive execution to evaluate and demonstrate product performance.
• Coordinate study activities and logistics, and keep cross-functional teams, including Engineering, aligned on timelines, priorities and issues.
• Analyze and interpret study data, including method comparison, precision and bias, using tools such as JMP, GraphPad Prism, R or Excel, and partner with Biostatistics on analysis approaches.
• Work with Data Management and Data Science to ensure study data is complete and ready for analysis.
• Summarize study data, prepare figures and presentations that turn results into clear conclusions to support internal decision-making and regulatory submission.
• Author or contribute to study protocols, reports and scientific summaries that support regulatory submissions.
• Work with Regulatory Affairs and Quality to ensure studies and documentation meet applicable requirements, including GDP, GLP, GCP and FDA expectations.
• Draft and maintain SOPs, work instructions and training materials.
• Mentor, train and support research associates, interns and site staff, and build strong working relationships with external partners and study sites.
• Identify opportunities to incorporate AI tools for process improvements and stay current on diagnostic technologies and relevant regulatory and scientific standards.

What You Will Bring

Required Qualifications

• Education and Experience: Bachelor's degree in a life science or related field with 10+ years of relevant experience; or a Master's degree with 7+ years; or a PhD with 5+ years.
• All candidates must have at least 3 years of industry experience in a laboratory-based or regulated environment (e.g., diagnostics, clinical laboratory, medical device, biotech or pharma).
• Laboratory and Assay Knowledge: Hands-on laboratory or assay experience and a solid understanding of analytical performance concepts such as precision, accuracy and bias.
• Study Design and Execution: In-depth understanding of clinical study design and methodology in the diagnostics or medical device industry, with the ability to design a well-controlled study or experiment, including logistics and documentation.
• Troubleshooting and Problem Solving: Strong troubleshooting and problem-solving skills, with the ability to work cross-functionally to identify the root cause of an issue, adapt quickly and keep work moving.
• Data Analysis: Strong data analysis and critical data interpretation skills for scientific and clinical data, with experience in tools such as Excel, JMP, GraphPad Prism or R.
• Familiarity with method comparison and precision analyses; Biostatistics support is available for advanced statistics.
• Quality Mindset: Experience working in a regulated or quality-controlled environment (e.g., GCP, GLP, CLIA or ISO), with a strong commitment to data integrity and documentation.
• Training and Relationship Building: Experience training others on procedures or equipment, and building productive working relationships with external partners, collaborators or customers.
• Communication: Exceptional written and verbal communication skills, including the ability to write clear reports and explain findings to technical and non-technical audiences.
• Independence and Adaptability: Ability to manage multiple priorities, work with increasing independence, and represent the team professionally in unfamiliar or off-site settings.

Preferred Qualifications

• Advanced degree (MS, PhD) in clinical chemistry, biochemistry, chemistry, biomedical engineering, laboratory medicine or another relevant life science.
• Experience in study designs for IVD is strongly preferred, specifically for clinical chemistry, immunoassays, hematology and/or multi-analyte diagnostic platforms.
• Experience with IVD or medical-device products and FDA regulatory submissions (e.g., 510(k), CLIA waiver).
• Familiarity with GCP, FDA regulations and CLSI guidance for diagnostic validation studies.
• Demonstrated experience incorporating AI in day-to-day work to improve efficiency.
• Experience working with clinical laboratories, external study sites or CROs.
• Experience mentoring junior team members or leading workstreams.