Reporting to the Head of Clinical Supply Chain the Manager, Clinical Supply Chain will ensure that all clinical trials, including multiple global Ph III studies, have timely and adequate supply for administration to patients. The Clinical Supply Chain group is involved in a clinical trial from the early stages of inception to study closure. This role includes demand forecasting, determination of an appropriate presentation to the clinical site and subject, setting production schedules, inventory management at depots and sites, order management and proof of delivery, return or destruction and global distribution logistics including import and export management
A biopharmaceutical start-up founded in 2011 that are focused on delivering innovative solutions in endocrinology and oncology. Although only one year old they have ambitious growth plans and have 5 global phase III programs planned for 2017/18.
Essential Duties and Job Functions
• Act as a key interface between the CMC and clinical teams.
• Interpretation of a protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time.
• Managing clinical labeling including label design, translation and production.
• Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts and regular inventory update to project teams.
• Manage international distribution and logistics for clinical programs, including importing and exporting clinical supplies
• Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution instructions with clinical supply chain vendors.
• Develop supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
• Setting up Integrated Voice and Web Response Systems with the clinical team, including UAT testing.
• Monitor regularly drug expiration; initiate inventory release and re-supply with the IXRS system, serving as the unblinded inventory manager.
• Write and execute test scripts for supply chain management in the IXRS system.
• Achieve operational objectives by providing information and recommendations to strategic plans and Budget reviews
• Support department budget activities.
• Review departmental SOPs and ensure updates and compliance with industrial standards.
• Develop strong internal collaboration with stakeholders, such as Clinical Operations, Regulatory Affairs, Quality, Pharmaceutical Sciences and Manufacturing functions, to ensure high customer satisfaction
• Perform other duties as assigned.
• BS or MS degree with 10+ years industry experience in clinical or commercial supply chain management.
• Proven experience with supply and demand forecast planning, clinical labeling, packaging and distribution including cold chain, importing and exporting logistics.
• Experience in assisting set-up of Integrated Voice and Web Response Systems for global clinical studies.
• Experience in sourcing and managing comparator drugs and other co-meds for clinical studies.
• Experience in CMO and CRO vendor management.
• Working knowledge of drug development process (Phase I-IV).
• Working knowledge of cGMPs and familiar with US and EU regulations
• Ability to handle multiple projects simultaneously.
• Proven project management skills.
• Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization.
• Finance related experience including preparing and supporting department budgeting forecast.
To discuss this opportunity further please contact Jack Keller firstname.lastname@example.org