Director, Clinical Data Management & Data Science - Truvian Sciences - Career Page Skip To Job Description View All Jobs View Our Website At Truvian, giving individuals unprecedented access to information that shapes their health is the bold mission that drives us. If you're interested in being part of a team that is set to disrupt healthcare, explore our openings and apply. Director, Clinical Data Management & Data Science San Diego, CA Full Time Senior Manager/Supervisor Share ABOUT TRUVIAN Want to work for a fast-paced and disruptive company that is working to revolutionize blood testing? Truvian is a healthcare company at the intersection of diagnostics and consumer tech. We are developing an automated, benchtop diagnostic system to provide lab-accurate results in 30 minutes for a comprehensive suite of health tests. Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from one small blood sample, in minutes, in a retail setting or private clinic. To us, our work at Truvian is more than a job – It’s a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to put health information where it belongs - in the hands of the individual. We are partners in the belief that talented people, working as a team, can make every day an adventure. Come join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today’s connected consumers! JOB SUMMARY Truvian is seeking a strategic and technically adept Director, Clinical Data Management & Data Science build and lead a multidisciplinary team responsible for clinical data strategy, management, analytics, and statistical sciences. This role is pivotal in ensuring data integrity, regulatory compliance, and operational efficiency across the product lifecycle—from early research through regulatory submission and post-market surveillance. This position is ONSITE. The Director will architect and scale Truvian’s clinical data ecosystem — spanning database design, data pipeline integration, clinical data quality, statistical analysis, and data visualization — to support assay validation, regulatory submissions, and real-world evidence generation. The ideal candidate combines strategic leadership with hands-on technical expertise in biostatistics, clinical data systems, and data science for diagnostics. This role requires in-depth expertise in the IVD industry, including knowledge of FDA regulations (21 CFR Part 11, Part 820), and a proven ability to lead data initiatives in a regulated environment. HERE’S WHY YOU WILL LOVE THIS ROLE Unique Growth Opportunity: Gain hands-on experience across clinical studies, data analysis, regulatory submissions, and product development. Data-Driven Innovation: Work alongside experienced leaders, contributing to real-world healthcare solutions backed by rigorous data. Fast-Paced Start-Up Culture: Be part of an agile, mission-driven team where your work has immediate impact. Professional Development: Receive mentorship and opportunities to expand your technical and industry knowledge. Meaningful Impact: Help bring innovative diagnostic products to market that can improve patient outcomes. You love and thrive in a fast-paced and dynamic environment where you can implement fresh ideas, new processes, and make things happen quickly without a bunch of red tape 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, and a variety of healthy snacks WHAT YOU WILL DO Strategic Leadership Develop and execute a unified, robust, and scalable data strategy to support clinical trials, R&D studies, and regulatory submissions. Build and mentor a high-performing team of data managers, database programmers, biostatisticians, and data scientists. Serve as a senior advisor to Clinical, R&D, and Regulatory leaders on data architecture, analytics, and evidence strategies. Ensure alignment of data architecture with business goals and regulatory
requirements. Data Infrastructure and Systems Development Lead the design, integration, and governance of clinical databases and data pipelines from the ground up. Oversee implementation and validation of EDC systems, LIMS, and data warehouse tools to harmonize internal and CRO data sources. Guide the creation of user-friendly tools for data input, extraction, and analysis across teams. Ensure compliance with 21 CFR Part 11, GCP, HIPAA, and other applicable data regulations. Hire, mentor, and manage a team of data professionals to support clinical and R&D initiatives. Clinical Data Management Establish SOPs, standards, and templates for data collection, cleaning, reconciliation, and database lock. Direct data management activities for clinical studies, ensuring data quality, completeness, and traceability. Collaborate with CRO partners and central labs to ensure consistent data flow and integrity. Biostatistics & Data Science Provide strategic direction for statistical design, analysis, and interpretation of clinical and analytical validation studies. Oversee development of statistical analysis plans (SAPs) and ensure robustness of models and results. Guide exploratory and confirmatory data analyses, leveraging both traditional biostatistics and modern data science/ML techniques. Drive the development of data visualization dashboards and analytic tools to support real-time decision-making. Cross-Functional Collaboration Partner with Clinical Operations, Regulatory Affairs, Quality, and Product Development teams to ensure alignment of data strategy with business goals. Support regulatory submissions (FDA, IVDR) through clear, validated, and reproducible data outputs. Translate complex data analyses into compelling, clear narratives for scientific and regulatory audiences. WHAT YOU WILL BRING Required: Master’s or PhD in Biostatistics, Data Science, Biomedical Informatics, or related quantitative field. Minimum of 10 years of experience in clinical data management, biostatistics, or data science roles within diagnostics, medical devices, or pharmaceuticals Minimum of 5 years of management and leadership experience Proven experience building and leading data teams (data management, biostatistics, and informatics) from the ground up in a regulated environment. Demonstrated ability to design and integrate clinical databases and data pipelines across multiple systems and vendors. Strong command of SQL and relational databases (e.g., PostgreSQL, MS SQL Server). Deep understanding of FDA regulations, including 21 CFR Part 11, Part 820, GCP, ICH E6, and regulatory
requirements for IVD data. Familiarity with EDC systems (Medidata, REDCap, etc.), data visualization tools (Tableau, Spotfire, Power BI), and data standards (CDISC/SDTM, HL7/FHIR). An analytical mindset with strong attention to detail and the ability to draw meaningful insights from complex datasets. Proactive, self-motivated, and eager to take ownership of tasks and learning opportunities. Exceptional communication skills and ability to translate complex statistical concepts and data into clear, actionable insights for technical and non-technical audiences. Comfortable working in a fast-paced, start-up environment with shifting priorities. Preferred: Knowledge of cloud platforms (AWS, Azure) and data governance frameworks. Startup or small-company experience building infrastructure from scratch Prior experience supporting FDA submission data
requirements for IVDs (e.g., 510(k), PMA, EUA). SALARY RANGE $196,000 - $216,000 This range encompasses the diverse set of factors considered in making
compensation decisions, including, but not limited to, experience, skills, knowledge, abilities, education, licensure, certifications, and other business and organizational needs. Salary offers are determined based on final candidate
qualifications and experience. Placement within the
compensation range is determined by internal equity and relevant
qualifications. HOW TO STAND OUT Interested candidates are encouraged to submit a cover letter along with their resume. The cover letter is an excellent opportunity to share how your experience aligns with our mission, your approach to collaboration, and how your statistical expertise can support innovation in IVD assay development. Equal Opportunity Statement Truvian provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence,
compensation, and training. Share Apply Apply for this position Required * First Name * Last Name * Email Address * Phone * Address Resume * We've received your resume. Click here to update it. Attach resume or Paste resume Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume Paste your resume here or Attach resume file Cover Letter Are you willing to relocate? * No answer Yes No What's your citizenship / employment eligibility? * No answer I am a U.S. Citizen/Permanent Resident Non-citizen allowed to work for any employer Non-citizen allowed to work for current employer Non-citizen seeking work authorization I am a Canadian Citizen/Permanent Resident Other What's your highest level of education completed? No answer GED or Equivalent High School Some College College - Associates College - Bachelor of Arts College - Bachelor of Fine Arts College - Bachelor of Science College - Master of Arts College - Master of Science College - Master of Fine Arts College - Master of Business Administration College - Doctorate Medical Doctor Other College or University LinkedIn Profile URL: * Desired salary * Earliest start date? References: Please enter names and contact information: Are you legally authorized to work in the United States? * -- No answer -- No Yes Will you now or in the future require visa sponsorship to work in the United States? * -- No answer -- No Yes Are you willing and able to work onsite at Truvian’s headquarters in San Diego, CA? * -- No answer -- No Yes Do you hold a Master’s or PhD in Biostatistics, Data Science, Biomedical Informatics, or a related quantitative field? * -- No answer -- No Yes Do you have 10+ years of experience in clinical data management, biostatistics, or data science within the diagnostics, medical device, or pharmaceutical industry? * -- No answer -- No Yes Do you have 5+ years of management and leadership experience? * -- No answer -- No Yes Have you built and led data teams (data management, biostatistics, informatics) from the ground up in a regulated environment? * -- No answer -- No Yes Do you have experience leading clinical data strategy and operations from early research through regulatory submission and post-market phases? * -- No answer -- No Yes Have you provided strategic direction for biostatistics and data science activities in a regulated clinical environment? * -- No answer -- Yes No Have you supported FDA submission data
requirements for IVD products (e.g., 510(k), PMA, EUA)? * -- No answer -- No Yes Have you led the development of statistical analysis plans for IVD analytical validation, clinical performance, or bridging studies? * -- No answer -- Yes No Are you familiar with IVD study design and statistical methods required for analytical performance evaluation under CLSI guidelines (e.g., EP05, EP07, EP17)? * -- No answer -- Yes No Have you supported FDA submission data
requirements for IVD products (e.g., 510(k), PMA, EUA)? * -- No answer -- No Yes Human Check * I consent to receive SMS/text messages regarding my job application with Truvian Sciences. These messages may include updates on my application status, interview invitations, reminders, and other information directly related to this job application. Message frequency will vary. Message and data rates may apply. Reply HELP for help or STOP to cancel. Submit Application This website uses cookies and other analytics technologies. By selecting "Allow", you consent to the recording, use and sharing of your website activity by this website and its service providers. Allow Reject All Powered by
