Sr Director, Clinical Data Management
Kriya Therapeutics, Inc.2 days ago
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OnsiteFull-timeDirector
Summary
Kriya Therapeutics, Inc. is seeking a Sr Director, Clinical Data Management to join their team in Morrisville, NC. The role involves setting the vision, direction, and strategy for Data Management across the clinical development portfolio.
About the Role
As the Senior Director, Clinical Data Management, you will oversee the planning, execution, and quality assurance of clinical data management activities, ensuring regulatory compliance and data integrity throughout the product development lifecycle. You will develop and implement comprehensive clinical data management strategies, provide leadership to the Data Management function, and collaborate cross-functionally to resolve data management issues in clinical trials.
About You
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.
Preferred:
- Experience in gene therapy, rare/orphan disease highly desirable.
- Experience with designing, standardizing and implementing data management strategies and standards for global development programs.
- Experience in regulatory filings (e.g., IND, CTA, NDA, BLA) highly desired.
Benefits
- Medical, Dental and Vision coverage.
- 401(k) with Company Match.
- Short and Long-term Disability Benefits.
- Company Paid Holidays.
- Flexible Time Off.
- Cyber Safety protection.
- Employee Assistance Program (EAP).
- Life Insurance.
- Equity.
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. Kriya is a biopharmaceutical company developing gene therapies to address chronic diseases affecting millions of people around the world. With operations in Research Triangle Park, North Carolina, and Palo Alto, California, Kriya has raised over $600 million to advance a broad pipeline of gene therapies in ophthalmology, metabolic disease and neurology. For more information, please visit www.kriyatx.com and follow us on LinkedIn and X (Formerly Twitter).
Morrisville, NC