Sr Director, Clinical Supply Operations

Kriya Therapeutics Inc•Morrisville, NC

61d

About The Position

The Senior Director, Clinical Supply Operations will lead our global clinical supply chain strategy and operations. This critical role will oversee all aspects of clinical trial material management, from forecasting and manufacturing coordination through distribution, reconciliation and inventory management of depots and clinical sites worldwide. The ideal candidate will bring deep expertise in clinical supply management, strong leadership capabilities, and a proven track record of supporting complex clinical programs in the biotechnology industry.

Requirements

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.
Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor

Nice To Haves

Experience in gene therapy, highly desirable
Experience in regulatory filings (e.g., IND, CTA, NDA, BLA) highly desired

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.