Executive Director, Supply Chain

As a key member of the CMC Leadership Team, the Executive Director, Supply Chain, will drive the strategic vision, operational execution, and regulatory compliance of our clinical supply operations. This role is responsible for ensuring the seamless and compliant global distribution of investigational medicinal products, supporting clinical programs critical to our pipeline. Reporting to the SVP, Manufacturing & Supply Chain, this leader will collaborate cross-functionally with Clinical Development, Clinical Operations, Regulatory, Quality, CMC, and Commercial teams, providing senior-level guidance on clinical supply strategy.

ESSENTIAL JOB FUNCTIONS:

• Responsible for leading and developing drug supply strategy, planning, and overall management of all aspects of drug supply chain activities including global Phase I - III clinical studies as well as commercial drug supply chain activities.
• Responsible for providing strategic leadership and vision for Investigational Medicinal Supply Chain (IMSC) and associated department staff.
• Responsible for providing operational leadership and oversight of commercial drug packaging, labeling, distribution and 3PL activities in collaboration with the commercial sales organization.
• Responsible for management of IMSC activities and demonstrating operational excellence in developing, and executing interdependent workflows with Clinical Operations, Quality Assurance and Global Project Team management to ensure successful Drug Development Activities are achieved across all areas of IMSC deliverables.
• Contribute vital tactical support and leadership in supply chain and logistics management while identifying and pursuing strategic opportunities to improve IMSC capacity, forecasting & planning models, all IP materials including comedications, comparators, and processes, IVRS management, and overall IMSC performance and efficiencies.
• Establish operating policies and procedures and provide comprehensive coordination of complex global supply chain operations, inventories, materials, and procurement while ensuring compliance to worldwide regulations and guidelines.
• Coordinate drug supply delivery timelines with Clinical and CMC; Packaging, Labeling, and Distribution CRO's; and indirectly with GMP manufacturers, QA, and Regulatory Affairs.
• Lead the team in monitoring and tracking global clinical supply inventories at the clinical site level for studies; maintain forecasts and provide inventory and logistics management of IP adjusting drug distribution plans with coordination of packaging, labeling at Contract Packaging and Procurement Vendors.
• Provide IMSC project leadership and management, and act as knowledgeable resource for establishment of effective collaboration with Clinical Operations for seamless delivery of IP to patients worldwide.
• Manage extensive internal and external touchpoints and maintain close communications with all IMSC groups to ensure the adequate supply of clinical supplies throughout the duration of multiple WW clinical trials including oversight of drug order requests, resupply, and processes.
• Support financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials; and reconciliation of drug distribution invoices with finance staff to maximize productivity, efficiency, and overall business performance.
• Contribute and review the preparation of clinical protocols, clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinate the origination, proofing and translation of clinical study labels and generation and updating with quality assurance all IMSC related SOP's.

JOB SPECIFICATIONS:

• Technical degree or equivalent (BS / MS), preferably in a scientific or pharmaceutical discipline
• 15+ years of leadership experience in the pharmaceutical or biotech industry, with a proven track record of leading and scaling clinical supply chain organizations.
• Demonstrated ability to set and execute long-term strategic goals for clinical supply chain operations, ensuring alignment with corporate objectives.
• Extensive experience engaging with executive leadership teams, including presenting strategic plans, risk mitigation strategies, and operational performance metrics.
• Proven success managing complex global supply chain operations, including vendor partnerships, contract negotiations, and compliance with international regulatory agencies (FDA, EMA, PMDA, etc.).
• Strong financial acumen, including oversight of clinical supply budgets, cost efficiency initiatives, and long-term investment planning.
• Enterprise-wide leadership experience, with the ability to influence and collaborate across departments, ensuring clinical supply chain integration into R&D and commercial strategies.
• Track record of building and leading high-performing teams, including succession planning, talent development, and organizational effectiveness.
• Proven expertise in managing regulatory inspections, audits, and compliance strategies in collaboration with Quality and Regulatory Affairs.
• Deep technical knowledge of clinical trial supply planning, including forecasting, IVRS/IRT systems, inventory management, and GMP/GCP compliance.
• Exceptional executive communication skills, with experience presenting to senior leadership, external partners, and regulatory agencies.

TRAVEL REQUIREMENTS:

• Travel between US offices and may require other meeting locations internationally

The base range for this role is $260,647 - $307,515 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.