Clinical Supply Manager

This remote opportunity is with a small biopharmaceutical company that has been established for over 10 years developing products to prevent and cure infectious disease and cancer. The ideal candidate will be taking over the work of the current supply manager and start on a part-time basis before transitioning to a full 40 hours. The current contract can last up to 3 years and has potential to convert permanent! Overview:We are looking for an experienced Clinical Supply Manager (CSM) with a sound background in pharmaceutical product development to re-design, implement, and optimize the clinical supply chain process and ensure global clinical supply for our pipeline products.Top Skills:Experience working with temperature variant products (-50 degrees and lower).

5+ years' experience in production planning and inventory control in the bio/pharmaceutical industry.

Experience with IMPs that are given as IV administration.

Experience with working with biological safety product(s) 1 and/or 2 is preferred.

Responsibilities:Provides strategic direction for clinical supply chain planning activities for clinical trial studies

Actively participates in project team meetings to work with cross functional teams including Technical Development, Clinical Operations, Regulatory Affairs, and Quality Management to provide feedback from a clinical supply chain perspective.

Provide oversight to CMOs for labeling and packaging, drug depot service, transportation logistics, IMP relabeling coordination.

Owns the clinical demand forecasting, clinical demand planning and clinical inventory planning. Develops the program level demand planning forecasts and budgets based on the book of work for clinical drug supplies through all phases of clinical development for assigned programs

Monitors ongoing study level activity to ensure sufficient supply. Manage inventory targets and safety stock levels.

Develop a labeling strategy that meets regulatory and study requirements. Lead the development and approval of label text and label proofs including country-specific translations.

Manage the logistics of relabeling the IMP with extended expiration date.

Reviews and provides input and approval for set up of user requirement specifications for the Interactive Response Technology (IRT) system.

Support preparation of clinical study manuals/documents such as the pharmacy manual.

Support Clinical Trial Management, Quality Management, and Technical R&D of in-use stability and compatibility tests as needed for clinical administration of the protocol.

Education Requirements:Bachelor’s Degree in Life Sciences, Business, Engineering, Supply Chain Management or related field. MSc/MBA is desirable.

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