Manager, Biosample Operations - #19529194
Kaleido Biosciences, Inc.
Manager, Biosample Operations
Kaleido Biosciences is a clinical-stage biotechnology company engaged in the development of novel chemistries that unlock the power of the microbiome to revolutionize health. The Company has built the first R&D engine to systematically create, discover, and develop interventions that activate metabolic processes in the microbiome to treat disease and maintain health. Since its founding in 2015 by Flagship Venture Labs, Kaleido has advanced candidate products into clinical studies across programs for rare genetic diseases, oncology and infectious disease. The Company is also creating consumer products that optimize the microbiome's natural roles in promoting health.
Summary of Key Responsibilities:
- Plan, organize and oversee clinical sample and sample meta data management including the collection and shipping of biosamples, sample processing and storage, and inventory management. Includes ensuring that the Kaleido internal sample tracking databases and monitoring, tracking and reconciliation of external clinical sample metadata is managed to meet study and program timelines.
- Coordinate with cross-functional R&D teams to operationalize biomarker and laboratory analysis including appropriate study kit design, laboratory manual and requisition development, and laboratory/central lab selection to ensure sites can meet sample handling needs of the study
- Manage key vendors and CROs to support clinical sample collection, central laboratory services, sample storage, and/or biomarker analysis including drafting and reviewing RFPs, vendor selection, defining scopes of work, vendor management, and contract management in support of study or research objectives and goals.
- In coordination with Clinical Operations, provide education and training for sample collection, handling, and shipment, which may include optimization of laboratory manuals, contributing to the development of patient and site-friendly sample collection materials, presenting sample collection requirements at Investigator Meetings, or training of sites on collection procedures
- Support sample analysis data transfer, data reconciliation, and data review
- Establish, monitor and report on key deliverables and timelines associated with partner laboratories or CROs responsible for sample handling or analysis.
- Accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, sampling materials, logistics & shipping as needed
- 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
- 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.
Kaleido Biosciences is an EEO employer committed to an exciting, diverse, and enriching work environment.