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. This role is ideal for someone looking to make tangible impact in product development, clinical and regulatory strategy of a diagnostics product and improving patient care.. Background and experience in clinical laboratory science, assay development, clinical research or related fields in the in vitro diagnostics (IVD) industry are strongly preferred.

Location and Work Arrangements
Location: San Diego, CA (Onsite)
This role requires regular onsite work. We welcome applications from qualified candidates; however, relocation assistance is not provided for this position. Candidates should be located within commuting distance of the office.

Visa Sponsorship
Candidates must be authorized to work in the United States on a full-time basis. Truvian does not currently provide visa sponsorship or support employment-based immigration petitions for this role.

Here's Why You'll Love This Job

• Be part of a pioneering team in the healthcare diagnostics space.
• Work on an FDA-cleared platform and contribute to its continued growth.
• Take on meaningful studies from design through final report, with direct visibility to leadership and influence on decision making.
• Collaborative and innovative work environment.
• Opportunities for professional growth and development.
• You'll have great perks such as:
  • Generous benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K)
  • Flexible vacation
  • Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks
  • Onsite gym
  • Farm to table onsite restaurant including a 30% discount

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.

SUPERVISORY ROLE

• No direct supervisory responsibility; may provide training or technical guidance to junior team members.

COMPENSATION
$130,00 to $168,000
The salary range for this position represents the anticipated range for qualified candidates. Compensation decisions are based on a variety of factors, including relevant experience, skills, education, training, certifications, internal equity, market data, and business needs. The final compensation offered to a successful candidate will be determined based on these factors and the requirements of the role.

PHYSICAL DEMANDS AND ABILITIES

• Ability to safely lift, carry, and move materials weighing up to 5 pounds on a regular basis.
• Ability to remain stationary and move about the work environment as needed to perform job duties.
• Ability to perform visual tasks associated with the position, including reviewing data, inspecting materials, and operating laboratory or computer equipment, as applicable.
• Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.

Interested candidates are encouraged to submit a cover letter along with their resume. The cover letter is an opportunity to highlight how your experience in assay and/or panel architecture aligns with our mission, your approach to technical leadership and cross-functional collaboration, and how your expertise has driven innovation in diagnostic product development and complex assay systems.