Kriya Therapeutics, Inc. · 2 months ago
Sr Director, Clinical Data Management
Morrisville, NC, US
Full-time
Onsite
Director/Executive
12+ years expKriya Therapeutics, Inc. is a biopharmaceutical company focused on developing life-changing gene therapies. The Senior Director, Clinical Data Management will set the vision and strategy for Data Management across clinical development, ensuring compliance and data integrity throughout the product lifecycle.
BiotechnologyHealth CareLife ScienceNeuroscience
Responsibilities
Develop and implement comprehensive clinical data management strategies aligned with company objectives and regulatory requirements
Provides strong leadership and inspiration to the Data Management function. Forecasts and manages Data Management resources needs, budget and timelines. Hires, develops, and retains talents. Responsible for the performance management of the Data Management function, including performance of outsourced data management activities
Establish and maintain data management standards, processes, and best practices across all clinical programs
Collaborates within the function and cross-functionally to resolve issues pertaining to data management in clinical trials and submissions work
Proactively identifies and manages risks for the data management function and supports functional risk identification/management efforts globally
Serves as the internal Data Management expert to provide strategic thinking for outsourcing strategy. As a member of the CRO governance committee, provides strategic leadership in Data Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities
Serves as a Data Management expert accountable for robust RD data management processes (including but not limited to CRF/eCRF design, all steps from database development to database release, data review and cleaning, database lock), to ensure data quality/integrity and regulatory compliance
Ensures that Data Management Plans are consistent and regulatory compliant across studies and programs
Serves as the Data Management leader representing RD during regulatory inspections and internal audits pertaining to RD activities and ensures inspection readiness of all data management activities conducted internally or outsourced
Qualification
Required
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 with designing, standardizing and implementing data management strategies and standards for global development programs is required
Experience in the management/oversight of CROs performing monitoring activities is required; experience with establishing FSP is desired
Experience with all aspects of clinical trial conduct (startup through close-out) is required
Prior demonstrated experience serving as a key leader to support organizational decision making and strategic planning required
Understanding of drug development and program management from pre-IND through regulatory filing
Demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required
Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
Preferred
Experience in gene therapy, rare/orphan disease highly desirable
Experience in regulatory filings (e.g., IND, CTA, NDA, BLA) highly desired
Previous involvement in the oversight and management of GCP regulatory inspections desired
Benefits
Medical, Dental and Vision
401(k) with Company Match
Short and Long-term Disability Benefits
Company Paid Holidays
Flexible Time Off
Cyber Safety protection
EAP
Life Insurance
Equity
And more!
Company
Kriya Therapeutics, Inc.
Our mission is to revolutionize medicine, with the ultimate goal of eliminating human suffering and enabling people to live without the burden of disease.
51-200 employees
H1B Sponsorship
Kriya Therapeutics, Inc. 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
2023 (1)
2022 (3)
Funding
Current Stage
Late StageTotal Funding
$921.32MKey Investors
Patient Square CapitalQVT FinancialTranshuman Capital
2025-08-15Series D· $320.82M
2023-07-26Series C· $150M
2022-05-16Series C· $270M
Leadership Team
Shankar Ramaswamy
Co-Founder and Chief Executive Officer
Sachiyo Minegishi
Chief Financial Officer
Recent News
2026-01-05
Kriya Therapeutics, Inc.
2025-12-01
Company data provided by crunchbase