Temporary - Clinical Biomarker 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 positions us to discover novel pathways and targets in immuno-oncology and will continue to generate important development programs. 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 www.fiveprime.com
Five Prime Therapeutics, Inc. is seeking a temporary Biomarker 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 biomarker samples.
- Participate in protocol and informed consent form (ICF) development to ensure logistical feasibility and consistency of biomarker sampling
- Contribute to the development of the central laboratory data specification document to ensure proper biomarker samples collection, processing, shipping, and analyses
- Participate in the CRF development process to ensure biomarker sampling information is appropriately collected for sample tracking and reconciliation purposes
- Coordinate and oversee sample shipments and query resolution from central laboratory/biorepository to contract analytical labs to ensure timely data delivery
- Manage interactions with contract analytical labs including technology transfers, budgets, contract management, and data transfer agreements
- Support teams to ensure biomarker samples are ICF and GCP/ICH compliant
- Work cross functionally to ensure contract analytical lab closeout, completion of final sample and ICF reconciliation, transfer of final sample documentation to the trial master file, and transfer of samples to long term storage
- Contribute to the development and maintenance of biomarker biosample related SOPs and WPs
- 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.