Kriya Therapeutics, Inc. · 2 months ago
Sr Director, Clinical Supply Operations
Morrisville, NC
Full-time
Hybrid
Director/Executive
12+ years expKriya Therapeutics, Inc. is a biopharmaceutical company focused on developing life-changing gene therapies. The Senior Director, Clinical Supply Operations will lead the global clinical supply chain strategy and operations, overseeing clinical trial material management and ensuring compliance with regulatory requirements.
BiotechnologyHealth CareLife ScienceNeuroscience
Responsibilities
Develop and execute comprehensive clinical supply strategies aligned with the company's clinical development pipeline and organizational goals
Oversee global supply planning, forecasting, and demand management for all clinical trials
Partner with the other function within Clinical Operations, Quality, Regulatory Affairs, Manufacturing and Supply Chain teams
Manage relationships with packaging, labeling, distribution, and depot vendors
Lead distribution strategy and packaging and labeling design
Support the development of the IRT systems implemented on clinical trials
Support clinical protocol development with supply chain feasibility and cost assessments
Ensure all clinical supply activities comply with GMP, GCP, and applicable regulatory requirements across global markets
Expert knowledge of the FDA GxP standards and regulatory guidance documents such as CFR, Annex 13, EU CTR. Able to support regulatory inquiries both face-to-face and with appropriate responses
Authors, revises and reviews standard operating procedures (SOPs), work instructions and business policies related to clinical supplies
Qualification
Required
Bachelor's degree in Life Sciences, Supply Chain Management, Engineering, or related field; advanced degree preferred
Minimum 12 years of experience in clinical supplies management within the biotechnology or pharmaceutical industry
Extensive knowledge of global clinical supply chain operations across all phases of clinical development
Deep understanding of GMP, GCP, ICH guidelines, and global regulatory requirements
Proven experience with IRT systems, clinical trial packaging, and global distribution logistics
Strong analytical and forecasting skills with experience in supply demand planning
Experience with designing, standardizing and implementing clinical supply strategies and standards for global development programs is required
Experience with all aspects of clinical trial conduct (startup through close-out) is required
Excellent project management capabilities with ability to manage multiple complex programs simultaneously
Outstanding communication and interpersonal skills with ability to influence cross-functional stakeholders
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
Preferred
Experience in gene therapy, highly desirable
Experience in regulatory filings (e.g., IND, CTA, NDA, BLA) highly 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
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