Sr.Director, Clinical Supply Chain

Sr.Director, Clinical Supply Chain

San Diego, California, United States

Essential Job Functions

Responsible for leading and developing drug supply planning strategy and overall management of all aspects of drug supplies (IP) for global Phase I III clinical studies as the leader of Investigational Medicinal Supply Chain (IMSC).

Responsible for providing strategic leadership of IMSC 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, IP materials 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 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 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 Requirements

Technical degree or equivalent (BS / MS), preferably in a scientific or pharmaceutical discipline

10+ years of prior experience in a pharmaceutical, biotech and demonstrated leadership of a clinical supply organization is required.

Lead strategic, operational and compliance related areas of IMSC governance and in accordance with organizational directives and regulations, execute on corporate goals and objectives.

Lead the department to improve productivity and efficiency while reducing operating costs.

Fundamental knowledge of inventory management and forecasting systems, IVR systems, and Clinical Trial Supply processes is required.

Provide leadership and oversight in monitoring inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues.

Proactively identifying potential issues, develop mitigating actions and notify Executive Management in a timely manner.

Collaborates with Quality Assurance, cGMP and cGCP Compliance Specialists and Subject Matter Experts, and maintains a strong understanding of Global Health Authority regulations for packaging, labeling, systems, distribution, and vendor management is required.

Provide interpretation of regulatory guidance documents, regulations and directives and advising regarding their applicability and impact on internal labeling programs.

Create, develop, review, and revise clinical supplies SOPs.

Hold a fundamental understanding of ICH guidelines, GCP's, 21 CFR and Annex 13 requirements.

General working knowledge of essential computer applications (i.e., MS Word, Excel, PowerPoint, MS Project) and extensive knowledge of IVR systems.

Oversight for requirements, review, and approval of IVRS specifications from investigational materials perspective, oversee UAT.

Ability to influence and lead others in preparing for audits and inspections by identifying potential areas of risk and developing risk mitigation strategies.

Ability to multi-task effectively with strong organizational and leadership skills.

Excellent verbal and written communication skills.