Job Details

Director, Clinical Data Management & Data Science

Truvian is seeking a strategic and technically adept Director to build and lead a multidisciplinary team responsible for clinical data strategy, management, analytics, and statistical sciences. This role ensures data integrity, regulatory compliance, and operational efficiency across the product lifecycle.

About Truvian

Truvian is a healthcare company at the intersection of diagnostics and consumer tech, developing an automated, benchtop diagnostic system to provide lab‑accurate results in 30 minutes for a comprehensive suite of health tests. With a mission to make routine health testing convenient, affordable, and actionable, we are a fast‑paced, disruptive company working to revolutionize blood testing.

Why You'll Love This Role

• Unique growth opportunity across clinical studies, data analysis, regulatory submissions, and product development.
• Data‑driven innovation with real‑world healthcare solutions.
• Fast‑paced startup culture where your work has immediate impact.
• Professional development and mentorship.
• Meaningful impact on patient outcomes.
• Great perks: generous benefits, flexible vacation, craft coffee, healthy snacks.

Responsibilities

• Develop and execute a unified, scalable data strategy for 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.
• Lead the design, integration, and governance of clinical databases and data pipelines.
• Oversee implementation and validation of EDC systems, LIMS, and data warehouse tools.
• Guide the creation of user‑friendly tools for data input, extraction, and analysis.
• 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.
• 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.
• Develop statistical analysis plans (SAPs) and ensure robustness of models and results.
• 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.

Qualifications

• Master's or PhD in Biostatistics, Data Science, Biomedical Informatics, or related quantitative field.
• 10+ years of experience in clinical data management, biostatistics, or data science in diagnostics, medical devices, or pharmaceuticals.
• 5+ years of management and leadership experience.
• Proven experience building and leading data teams 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 (PostgreSQL, MS SQL Server).
• Deep understanding of FDA regulations, 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).
• Analytical mindset with strong attention to detail and ability to draw meaningful insights from complex datasets.
• Exceptional communication skills and ability to translate complex statistical concepts and data into clear, actionable insights.
• Comfortable in fast‑paced startup 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

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.