Temporary - Clinical Biosample Specialist
- 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.
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.
FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at www.fiveprime.com.
Five Prime Therapeutics, Inc. is seeking a Clinical Biosample Specialist to join the Clinical Biomarkers & Companion Diagnostics team. This is a contract position and the individual will report to the Manager of Clinical Biomarkers & Companion Diagnostics. This individual will work cross-functionally, with both internal and external stakeholders, to plan, coordinate, and oversee all operational activities required to manage the lifecycle of the clinical biosamples.
- Participate in the protocol and informed consent form review process to ensure logistical feasibility of biosample handling, alignment with planned analyses and ICH/GCP compliance
- Participate in the CRF development process to ensure biomarker sampling information is appropriately collected for sample tracking and reconciliation purposes
- Provide input on kit design, sample processing, collection, storage and shipping to ensure that the investigator sites can meet the sample handling needs of the study
- Navigate the sample tracking system to track the life cycle of the samples, identify trends and gaps and obtain sample metrics
- In partnership with the Study Lead, provide adequate training and guidance to the investigator sites and study monitors for biosample collection, handling and shipment
- Provide input on laboratory vendor contracts and data transfer agreements and monitor data delivery timelines and receipt
- Plan, coordinate and oversee sample shipments and query resolution at laboratory vendors
- Serve as an active member of the Clinical Study Teams and provide regular biosample metrics and status updates
- B.S./ B.A. in biological sciences with 3+ years of relevant industry experience
- Knowledge of FDA & ICH/GCP regulations and guidelines
- Proficiency in MS office including Word, Excel, PowerPoint and other applications
- Proven track record of sample management, data management and contract management skills
- Ability to manage work flows and data sets
- Good initiative and ability to work independently
- Excellent written and interpersonal communication skills
- Detail oriented with the ability to work independently and manage multiple competing priorities
- Effective team player and ability to collaborate with cross functional clinical study teams
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.
Five Prime acknowledges that providers may be a valuable resource for identifying and recruiting candidates for employment. However, we require that all recruiters engage directly with Five Prime’s Talent Acquisition Team and comply with Five Prime’s requirements prior to transmitting any resumes/CVs or introducing any candidates to Five Prime. Five Prime’s Talent Acquisition Team is the only function within the Company that can enter into contractual relationships with external recruiters and recruiting agencies. As such, all unsolicited resumes, CVs, anonymous profiles, or candidate information you may submit to employees of Five Prime will become property of Five Prime and Five Prime will have no obligation to pay you or anyone else for the use of such information, including any finder’s, placement, introduction or placement fee.