Sr Director, Clinical Data Management

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Kriya is a biopharmaceutical company whose mission is to develop life‑changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary computational engine, in‑house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of Bio Space’s “2025 Best Places to Work.”

The Senior Director, Clinical Data Management sets the vision, direction, and strategy for Data Management across our clinical development portfolio. This role will oversee the planning, execution and quality assurance of clinical data management activities across the clinical development programs, ensuring regulatory compliance and data integrity throughout the product development lifecycle.

The ideal candidate has comprehensive expertise in data management of regulations and GCP requirements for drug development, advanced knowledge of Electronic Data Capture/related applications and industry standards, and advanced skills partnering with CROs and other third‑party vendors. Additionally, he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will have advanced experience working on Phase I‑IV studies within the biopharmaceutical industry across multiple therapeutic areas and is capable of leading DM activities to support regulatory submissions and inspections.

Finally, this position has advanced skills in continuous improvement, project management, change management, and risk management.

• Develop and implement comprehensive clinical data management strategies aligned with company objectives and regulatory requirements.
• Provide strong leadership and inspiration to the Data Management function. Forecast and manage Data Management resources needs, budget and timelines; hire, develop, and retain talent; and manage performance, including outsourced activities.
• Establish and maintain data management standards, processes, and best practices across all clinical programs.
• Collaborate within the function and cross‑functionally to resolve issues pertaining to data management in clinical trials and submissions work.
• Proactively identify and manage risks for the data management function and support global risk identification/management efforts.
• Serve as the internal Data Management expert to provide strategic thinking for outsourcing strategy and lead the CRO governance committee.
• Serve as a Data Management expert accountable for robust RD data management processes (including CRF/eCRF design, database development to release, data review and cleaning, database lock) to ensure data quality/integrity and regulatory compliance.
• Ensure that Data Management Plans are consistent and regulatory compliant across studies and programs.
• Serve as the Data Management leader representing RD during regulatory inspections and internal audits, ensuring inspection readiness of all data management activities conducted internally or outsourced.

• Advanced degree (MS/PhD) in Life Sciences, Statistics, Computer Science, or related field, or BS with equivalent experience.
• Minimum 12 years of clinical data management experience in pharmaceutical/biotech industry.
• 6+ years of leadership experience managing clinical data management teams.
• Deep expertise with EDC systems (Medidata Rave preferred) and clinical data standards (CDISC/SDTM/ADaM).
• Strong knowledge of GCP, 21 CFR Part 11, and global regulatory requirements.
• Previous experience working with global clinical trials and diverse regulatory environments.
• Experience in gene therapy or rare/orphan disease highly desirable.
• Experience designing, standardizing and…