Job Description

We are seeking an initiative-taking individual with clinical trial supply management experience to work in the exciting area of phage therapy. This individual will work closely with the external Vendors, Clinical Operations, cGMP Manufacturing, and Quality teams to ensure the clinical supply strategy is clear and the related plans are executed and aligned across functions.

Job description and technical requirements:

• Generates initial and revises drug forecast at study and program level, communicating demand requirements to CMC and other stakeholders.
• Coordinates procurement activities for cGMP and/or ancillary supplies.
• Manage protocol-level drug product labeling and packaging activities for clinical trial material.
• Interprets relevant protocol information to develop packaging/labeling design for clinical supplies.
• Advise team decisions related to Label/Packaging Regulatory requirements.
• Establishes distribution strategy and manages packaging/distribution timelines.
• Supports design and set-up of IRT system.
• Coordinates the origination, proofing and transition of clinical study labels.
• Proactively communicates drug supply delivery timelines to appropriate stakeholders.
• Coordinates the required documentation and activities for import and export of clinical supplies.
• Monitors global inventory and proactively communicates with all stakeholders to ensure adequate quantity and timely delivery of clinical supplies throughout duration of a trial.
• Monitors and manages retest dating for assigned study supplies.
• Proactively identifies potential risks, provides corrective plans, and resolves clinical supply issues.
• Provides information to support financial planning for global studies and monitors drug supply study budget.
• Establish and foster relationships with internal clinical operations, cGMP manufacturing, and Quality teams.
• Attend relevant weekly team meeting on site.

Qualifications and Experience:

• Bachelor’s degree required.
• 3+ years as the Sponsor primary drug supply manager, working with study blinded/unblinded team members and vendors.
• Strong experience and skills in the management of clinical supply chain coordination.
• Knowledge of regulations governing investigational products, including GMP and ICH/GCP guidelines
• Working knowledge of project team structure and processes
• Proactive approach to work, identifying potential issues well in advance and bringing them to the attention of appropriate personnel for resolution.
• Knowledge of project management and Clinical customer relationship building
• Knowledge of the ‘Customers’ team structures and processes
• Excellent verbal and written communication skills
• Ability to influence others
• Ability to multi-task
• Strong organizational skills
• Experience in conflict resolution and negotiation skills
• Knowledge of general computer skills (i.e. MS Word, Excel, PowerPoint, MS Project and Access

 

Posted On: Monday, April 15, 2024