Senior Associate/Associate, Clinical Supply Chain Management
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
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. Our industry-leading drug discovery platform, which includes comprehensive proprietary libraries of the extracellular proteome and differentiated screening capabilities, has led to a pipeline comprising five development programs in clinical trials across multiple indications in 2019. We also have several undisclosed research programs that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process using our proprietary screens to discover new immuno-oncology targets.
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. Discover more about FivePrime at www.fiveprime.com.
The Senior Associate/Associate Clinical Supply Chain will assist with planning and executing routine Clinical Supply Chain operations to support the company’s clinical trials. This role will partner with cross-function groups such as Clinical Operations, Regulatory Affairs, Quality Assurance, and Manufacturing Sciences/CMC to ensure all clinical trial depots and sites have adequate inventory levels of clinical supplies for the entire duration of the trials.
- Forecast IMP demand for global studies based on clinical study protocol and clinical study plan.
- Create, monitor, and adapt supply plans to support clinical study demand
- Develop clinical label text and IMP kit designs to comply with regulations and clinical trial needs.
- Collaborate with external CMO partners/vendors to manage labeling/packaging operations and comparator sourcing needs of each clinical trial.
- Partner with internal stakeholders to ensure clinical supplies are available on time while also maintaining compliance with quality and regulatory requirements.
- Oversee IMP shipments within the global distribution network and resolve any temperature excursion issues.
- Coordinate drug returns from site back to depot and assist with study drug reconciliation.
- Perform budget tracking for cost of clinical supply chain operations and manufacturing
- Participate in developing and implementing IXRS systems
- Bachelors degree
- 1-2 years experience in biotech or pharmaceutical industry required for Associate level role
- 3 + years experience in biotech or pharmaceutical industry is required for Sr. Associate level role
- Direct experience working on a Phase I to III clinical trial is preferred
- Strong understanding of various clinical trial designs is preferred
- Working knowledge of Good Manufacturing Practices (GMP), Good Clinical Practice (GCP), and Good Distribution Practice (GDP) is required.
- Experience with IXRS systems preferred
- Cold Chain Experience preferred
- Proficiency with Microsoft Office Suite is required
- Strong oral and written communication skills required
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.
All your information will be kept confidential according to EEO guidelines.