Truvian · 2 months ago
Director, Clinical Data Management & Data Science
San Diego, CA
Full-time
Onsite
Director/Executive
$196K/yr - $216K/yr
10+ years expTruvian Sciences is a healthcare company focused on revolutionizing blood testing through innovative technology. The Director of Clinical Data Management & Data Science will lead a multidisciplinary team responsible for clinical data strategy, ensuring data integrity, regulatory compliance, and operational efficiency throughout the product lifecycle.
BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedical Device
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
Hire, mentor, and manage a team of data professionals to support clinical and R&D initiatives
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
Qualification
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)
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
Company
Truvian
Our mission is to provide unprecedented access to blood testing. We enable sustainable healthcare with accessible blood testing for a healthier you.
51-200 employees
H1B Sponsorship
Truvian has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (2)
Funding
Current Stage
Late StageTotal Funding
$208.1MKey Investors
GreatPoint Ventures
2024-07-17Series D· $74M
2021-02-24Series C· $105M
2019-11-20Series B· $27.1M
Leadership Team
Jay Srinivasan
Chief Executive Officer
Dena Marrinucci
Chief Operating Officer (COO)
Recent News
2026-01-07
Company data provided by crunchbase