Sr Director, Clinical Supply Operations

About Kriya

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 BioSpace’s “2025 Best Places to Work.”

Role Overview

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.

Key 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.

Experience & Skills

• 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 in gene therapy, highly desirable
• 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.
• Experience in regulatory filings (e.g., IND, CTA, NDA, BLA) highly desired
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor

Work Environment

• Primarily desk-based, generally in an office or home office setting
• May involve extended periods of sitting and computer use
• Ability to stand for extended hours
• Ability to climb ladders/steps

Discover True Collaborative Teamwork

We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.

We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.

Rewards & 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!

Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.