Analista Programador Senior de PowerBuilder
Finout Madrid (Hybrid)
IMVT Corporation en New York City, New York, United States
Senior Director Clinical Supply Chain
IMVT Corporation New York City, New York, United States
$45,000 - $95,000
Partnership with Remote Ok
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
The Sr. Director, Clinical Supply Chain reports to the VP of CMC Operations & Global Supply Chain. The Sr, Director Clinical Supply Chain possesses a very good understanding of Clinical Supply Management and strategy, CMC regulatory, project management terminology and demonstrates effective communication skills.
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 across multiple IMVT studies. Communicate the supply strategies and supply needs back to CMC and develop am manufacturing strategy together with the technical team.
Improves and/or stablishes 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.
Perform financial planning for clinical supply management, including budgeting, forecasting, and strategic planning activities for clinical trials; and reconciliation of drug distribution invoices. Mentors and manages direct reports supporting clinical trial supply managers and operations support.
Lead and manage clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management. 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. Provide Packaging and Labeling/distribution vendor oversight and relationship management.
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.
The Sr. Director, Global supply chain, partners with the Clinical Operations group and CMC group to ensure continuous supply of Investigational Medicinal Product (IMP) for Immunovant trials. Support the development of packaging & labeling configuration, supports device assembly activities as they occur at packaging and labeling vendors, distribution and Interactive Response Technology (IRT) to supply study drug to global clinical trials using sound supply chain techniques.
Provide leadership and management, and act as knowledgeable resource for establishment of effective collaboration with Clinical Operations for seamless delivery of IP to patients worldwide.
Proactively identifying potential issues, develop mitigating actions and notify Executive Management in a timely manner.
Provide interpretation of regulatory guidance documents, regulations and directives and advising regarding their applicability and impact on internal labeling programs
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