Manager/Senior Manager, Study Material & Sample Management

Translational Medicine (560) · Seattle, Washington
Department Translational Medicine (560)
Employment Type Full-Time
Minimum Experience Manager/Supervisor

    Company:

     

    Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1/2 trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases.

     

    Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids, and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. Chinook trades on Nasdaq under the ticker symbol KDNY and has locations in Vancouver, BC, Seattle, WA and Oakland, CA.


    Position:

     

    Chinook Therapeutics is seeking an energetic, motivated, and experienced Manager/Sr. Manager of clinical and nonclinical study material and sample management to join our growing team. The candidate will lead, oversee and execute management of study materials and samples in support of global clinical and nonclinical studies. The Manager/Sr. Manager, Study Material & Sample Management will be responsible for the chain of custody, tracking and archival of study-related materials/ samples/specimens and will establish and maintain best practices in study-related material management to ensure compliance with GLP and GCP regulatory guidances. The individual may also assist the team in developing biomarker plans, including the strategy and goals, experimental validation, timelines and budget. The ideal candidate will be experienced in collaborating cross functionally to support different aspects of study-related materials/ sample/specimen management for nonclinical studies and clinical trial execution.  The role can be based remotely or near any of Chinook’s sites in Oakland, Vancouver or Seattle.


    Responsibilities include:

     

    • Plans, coordinates, and oversees management of nonclinical study-related materials/samples/specimens to ensure archival is in compliance with GLP regulations
    • Plans, coordinates, and oversees clinical sample management to ensure delivery of sample testing and data milestones
    • Coordinate sample logistics and communications between sponsor, sites, and specialty labs to ensure samples are handled/stored, shipped, tested, and data reported per study timelines and in adherence to SOPs, ICH/GCP, clinical protocols, laboratory manuals, and analysis plans
    • In collaboration with clinical operations, maintain chain of custody in life cycle of all biomarker samples (collection to final sample disposition) and associated records (sample manifests, requisitions, records of destruction)
    • Maintain program-wide sample records in LIMS (Open Specimen), track clinical study sample collection and testing status and present sample status
    • Collaborate with study team, clinical sites, and CROs to resolve discrepancies/lab queries
    • Contribute to relevant vendor management including contract setup, oversight of scopes of work, timelines, deliverables, budgets/invoices tracking, and vendor communication
    • Contribute to biomarker aspects of central lab setup and oversight, including drafting of lab manual processing instructions, design of lab kits, and shipping conditions for biomarker samples
    • Provide training in biomarker specimen processing and handling to sites and labs as needed, including leading biomarker training sections of SIVs


    Education, Experience, and Skills:

     

    • Life Science degree in scientific, medical, or healthcare area required
    • 5+ years of work experience in clinical development, 3+ years in clinical biomarker operations preferred
    • Exceptional attention to detail and ability to manage, plan, organize and conduct biomarker operations with minimal oversight
    • Strong knowledge and understanding of GLP/GCP practices and regulatory requirements for archival of nonclinical materials, and biospecimen chain of custody and clinical sample testing in compliance with ICFs
    • Understanding of biomarker technology platforms is preferred: flow cytometry, ligand-binding assays, transcriptomic and genomic profiling
    • Ability to work in a cross-functional, matrixed team environment and be an effective team player and strong individual contributor able to handle multiple tasks and deliver high quality results under tight timelines
    • Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and familiarity with navigating LIMS systems, preferably with Open Specimen
    • Therapeutic experience in autoimmune or kidney disease is a strong asset



    Chinook is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported.  We respect and value different experiences and viewpoints.  We act respectfully toward one another and embrace diversity of people and ideas. Having a diverse workforce made up of team members who bring a wide variety of skills, abilities, experiences, and perspectives is essential to our success. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.

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    • Location
      Seattle, Washington
    • Department
      Translational Medicine (560)
    • Employment Type
      Full-Time
    • Minimum Experience
      Manager/Supervisor