Director, Clinical Data Management & Data Science

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 is pivotal in ensuring data integrity, regulatory compliance, and operational efficiency across the product lifecyclefrom early research through regulatory submission and post-market surveillance. This position is ONSITE.

The Director will architect and scale Truvian's clinical data ecosystemspanning database design, data pipeline integration, clinical data quality, statistical analysis, and data visualizationto 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

• 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.

What You Will Bring

• 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.

• 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.

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.

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.