Posted 8 Feb 2024, 5:00 am
Senior Director Clinical Supply Chain at IMVT Corporation
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
- Interprets clinical synopsis and protocols and creates clinical forecasts.
- Fundamental knowledge of inventory management and forecasting systems, IRT systems, and Clinical Trial Supply processes is required.
- Oversee the execution of multiple clinical trials and proactively identifies potential supply chain issues, provides analysis and recommends solutions with the appropriate support from SMEs
- Oversees and supports study close out activities including returned good reconciliation, inventory destruction Managing and executing overall Project Delivery through coordination of CMC efforts assigned to the entire project team (including but not limited to CMC, Supply Chain, Legal, Procurement, Regulatory, Clinical Development, and Clinical Operations).
- Oversees the management of inventory and shipment logistics of all Immunovant product and potentially associated samples.
- Ensures temperature excursion process is executed as required.
- Liaison with Suppliers to manage relationships and drive triage level activities that require diligent focus with rapid start-up, resolution to issues, and respond to questions related to CMC projects.
- Oversees and provides recommendations on packaging design based on study requirements, distribution and blinding strategy, oversees the execution of initial supplies and resupplies for all IMVT studies. Designs and implements strategic plans to supply study drug to complex global clinical trials using sound supply chain techniques.
- Guides the IRT System Leads as necessary with regards to user requirement specifications management module(s) as applicable
- Reviews IRT strategy across IMVT studies to ensure consistency where applicable
- Leverages the inventory management capabilities of the IRT to appropriately manage studies
- Bachelor's degree in science, engineering, or another relevant field; advanced degree preferred
- Experience with global pharmaceutical/biotech development and manufacturing operations for development-stage biologics, including upstream/downstream process development, formulation development (pre-filled syringe), analytical development, and device development
- 10-plus years of relevant biopharmaceutical industry experience with 8 plus years in clinical supply management
- Deep understanding of IRT systems
- Extensive experience with clinical study design, execution of clinical trials and investigational supply management
- Ability to manage diverse project activities with global contract CMOs and create a collaborative environment
- Strong computer skills including MS Office
- Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results
- Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills
- Ability to think outside of the box and challenge the status quo
- Natural entrepreneurial spirit with unrelenting dedication to delivering results
- Desire to work in a fast-paced, innovative environment
- Natural collaborator who enjoys working on a cross-functional team
- Immunovant’ s headquarters is located in New York City. The position is flexible for remote work.
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel are required (10-20%)
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Source: Remote Ok