Clinical Biosample Manager
Location: South San Francisco, CA
Position type: Full-time
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immune-oncology protein therapeutics for patients with serious unmet medical needs. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and preclinical development.
We currently have three protein therapeutics in clinical trials:
- FPA008 – a monoclonal antibody that inhibits the CSF-1 receptor and is being studied in multiple tumor settings and pigmented villonodular synovitis (PVNS)
- FPA144 – a monoclonal antibody targeting FGFR2b for selected gastric cancers
- FP1039 – a FGF ligand trap for mesothelioma
On the strength of our unique discovery platform and capabilities, we have entered into strategic collaborations with leading global pharmaceutical companies. We currently have three active research collaborations with Bristol-Myers Squibb, GlaxoSmithKline and UCB Pharma, S.A.
Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. These values are reflected in our people and our products. We value our culture of openness, collaboration and productivity. Discover more about Five Prime at www.fiveprime.com.
We are seeking a highly motivated individual to join the Five Prime Therapeutics Inc. Biosample Management group within the Clinical Operations function. This individual will play a key role in assisting the Clinical Development team in management of laboratory vendors and biosample management.
Overall responsibilities will include planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biosamples (including participating in laboratory selection and oversight, collection, processing, analysis, data receipt and final repository) of non-safety biosamples in a clinical study. The BSM will partner closely with the Clinical Operations’ study lead(s), be assigned to multiple studies and provide biosample operational expertise to the Study Execution Team (SET) and other stakeholders. This position reports to the Director of Clinical Data Management.
Key responsibilities include:
- Plan, organize and oversee the collection and shipping of biosamples from investigator sites or centralized locations and subsequent delivery to assay laboratories. Partner with the SET to ensure the delivery of biosample data in accordance with study timelines.
- Manage relationships with laboratory vendors, provide input into trial-specific agreements and assess service level commitments of labs involved in sample analysis. Ensure issues are resolved or escalated in a timely manner.
- In partnership with the Study Lead, provide adequate training and guidance to the investigator sites and study monitors for sample collection, handling and shipment.
- Support sample analysis data transfer, data reconciliation, and data review.
- Create the Biosample Management Plan (BMP) for assigned studies to document the lifecycle and reconciliation plan for each sample type
- Participate in the identification, selection and oversight of laboratory vendors including drafting RFPs and defining scope of work in support of study objectives and goals.
- Accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, sampling materials, logistics & shipping as needed
- Provide regular biosample metrics and status updates to the SET. Investigate and address discrepancies detected from the biosample metrics with the Study Lead and Development Science colleagues and recommend effective solutions.
- Provide guidance during protocol and Informed consent form development to ensure logistical feasibility of biological sampling and alignment with ICH/GCP, appropriate policies, procedures, and sample testing plans
- Provide guidance on country and site feasibility relevant to kit design, sample processing, collection, storage and shipping to ensure sites can meet sample handling needs of the study
- Monitor effectiveness of investigator site sample handling training and quality of samples received and recommend corrective action as necessary
- Participate in the CRF development process to ensure lab sampling information is appropriately collected for sample tracking and reconciliation purposes
- Write and review SOPs and working practices.
- Other projects when assigned
- BS/BA in Life Science or related discipline
- 5+ years industry experience in drug development
- 5+ years clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines
- Proficiency in MS office including Word, Excel, PowerPoint and other applications
- Effective team player and ability to collaborate with cross functional clinical study teams
- Ability to prioritize projects and assigned tasks effectively
- Ability to manage lab vendors and oversee biosample management activities across multiple clinical trials
- Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, team-based environment
- Exercise right judgement to make critical business decisions
- Excellent written and interpersonal communication skills necessary to interface with outside vendors, consultants, and team members.
- Demonstrated strengths in planning, organizational, analytical skills, time management, problem solving, and attention to detail.
Please upload your cover letter and resume