Director, Clinical Data Management & Data Science

Truvian Sciences • San Diego, CA

73d • $196,000 - $216,000

About The Position

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!

Requirements

• 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.

Nice To Haves

• 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).

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Master's degree
• Number of Employees: 101-250 employees