What are the responsibilities and job description for the Senior Manager, Clinical Supply Chain Management position at Ventus Therapeutics?
About us :
Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.
Our proprietary drug discovery platform, ReSOLVETM, gives us the ability to discover and develop medicines through unique insights into protein targets and to create dynamic blueprints that can guide the development of differentiated therapies at a fast pace. We aim to use the ReSOLVE platform to improve the way medicines are discovered and developed, with the ultimate goal of restoring the health of people facing serious illnesses.
Position Overview :
The Senior Manager, Clinical Trials Supply Chain will be responsible for managing clinical drug product supply in support of multiple clinical studies across all phases of development. As a member of the Development team, this role will report to our Head of CMC.
Key Duties and Responsibilities :
- Manage investigational drug substance and drug product supplies in support of the clinical development pipeline.
- Ensure on-time delivery of study drug to patients / subjects and management of the clinical supply chain (packaging, labeling, distribution, inventory management, returns, and destruction of IMP / CTM)
- Work collaboratively with Clinical Operations, Clinical Development, Quality, Regulatory, and with external vendors (packaging, IRT)
- Work with cross-functional teams to define the clinical supply plan for each study; and participate in relevant team meetings providing clinical supply status reports and support
- Review clinical protocols for study supply requirements
- Review and approve label text in compliance with regulations, and manage translations and country specific requirements
- Contribute to the design of study drug packaging in accordance with needs of the study
- Manage vendors to perform the labeling, packaging, and global distribution of investigational product
- Develop requirements / specifications for clinical study drug and other drug supply as required (non-GMP and GMP), including inventory, retest dating, packaged product specifications, product shipping and storage specifications
- Contribute to study specific pharmacy manuals and supply related training / instructional materials (e.g. IM and SIV slides, dosing cards, accountability forms)
- Stay current on all Ventus SOP’s related to CTM / IMP distribution and follow procedures for release of IMP to clinical site(s)
- Contribute to annual budget and forecasting; track and approve invoices to contracts
- Provide Regulatory Affairs with applicable information and / or sections of IND / IMPD / CTA / etc. submissions
Requirements :
