Associate Director / Director, Clinical Supply Chain Management - South San Francisco , California, United States, 94080
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases. We have an industry-leading and differentiated drug discovery platform. Our comprehensive proprietary libraries of the extracellular proteome, differentiated screening capabilities and protein therapeutic generation and engineering capabilities comprise a unique and powerful IND engine that will continue to generate important development programs. This uniquely positions us to discover novel pathways and targets in immuno-oncology. Our success with our drug discovery platform has led to a pipeline that is on track to more than double to five development programs in clinical trials across multiple indications in 2018. We also have several undisclosed research programs at different points of the target validation and molecule generation phases that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process at the earliest stages with new screens planned this year.
Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. We value our culture of openness, collaboration and productivity. The company is in a strong financial position and has an effective executive team and Board of Directors. Discover more about FivePrime at .
Reporting to VP Manufacturing Sciences, this position will lead the clinical supply chain function and be responsible for providing strategic input and hands-on management of clinical supply chain to support phase 1 to phase 3 clinical trials. Responsibilities include planning and forecasting of clinical supply, overseeing clinical packaging, labeling and distribution operations at contracted manufacturing organizations. In addition, he/she will partner with other functional leaders from CMC, Regulatory Affair, Clinical Operation and Quality in support of the project teams and ensure timely drug supply for clinical trials. We seek someone who is a builder and can help lead us through path from IND to Commercial manufacturing.
- Key member of the Manufacturing Sciences leadership team to assess and support CMC and supply chain strategies.
- Lead clinical supply chain function to define and execute supply strategies including forecasting, label design, vendor selection, production oversight, distribution and inventory tracking in a cost-effective manner and in compliance with cGMPs.
- Identify opportunities to improve supply chain workflow. Remain current with industry best practices, trends and technologies.
- Oversee clinical supply chain budget and mentor supply chain staff.
- Interface with Clinical Operations and Regulatory Affair to enable clinical study set up and regulatory submissions
- Partner with Clinical Operation to develop IxRS systems.
- Manage vendor selection for labelling/packaging, comparator sourcing, depot selection and distribution.
- A Bachelor's Degree in Life sciences, Pharmacy or closely related field
- Up to 11 years of biotech or pharmaceutical experience is required for the Associate Director level
- 12 +years biotech/pharmaceutical experience of experience is required for consideration at the Director level.
- Extensive experience on clinical supply chain management for biologic products is essential.
- Hands on experiences on managing global phase 3 clinical trial is required.
- Direct experience on managing supply chain CMO's, contract review, and production oversight
- Strong knowledge on GXP requirement and experience on supporting regulatory submissions.
- Proven track record on effective clinical demand planning, logistics and international distribution.
- Excellent project management and communication skills, able to work with interdisciplinary teams to understand the demand, solve problems and make routine recommendations in a timely manner.
- Attention to detail and accuracy; and ability to work on a fast-paced environment are essential
- Commercial Supply Chain (packaging, 3PL) experience a plus.
At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.
FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments.
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