Director/Associate Director, Supply Chain Management – FibroGen, Inc. – San Francisco, CA, USA
The Director/Assoc. Director of Clinical Supply Chain ensures that all clinical trials have timely and adequate supply for administration to subjects. 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, and return or destruction. Additionally the Director/Assoc. Director implements and ensures group compliance to procedures for the production and distribution of investigation product.
• 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 and
• Preparation of a supply plan to support the demand forecast, including determination of supply
• Importing and exporting clinical trial material.
• Manage clinical packaging/distribution including negotiating contracts, designing clinical supply
plans and developing the distribution instructions with clinical supply chain vendors.
• Setting up Integrated Voice and Web Response Systems with the clinical team.
• Interfacing between the CMC and clinical teams.
• Assist the head of the department in managing the budget and ensure department adhere to the approved budget
• Managing the CRO and provide Metrix
• Review departmental SOP and ensure updates and compliance with industrial standards
Job Qualifications :
• BS/BA degree.
• Minimum 8+ years industry experience in clinical operations or supply chain management. Title
based on experience.
• Experience with clinical blinding practices.
• Experience setting up Integrated Voice and Web Response Systems.
• Working knowledge of drug development process (Phase I-IV).
• Working knowledge of cGMPs.
• Experience with clinical labeling, packaging and distribution including cold chain, importing and
• Strong analytical and problem solving skills.
• 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 managing the department budgeting forecast.
• Use of Microsoft Office including Word, Excel, PowerPoint, Visio and Microsoft Project