Biomarker Operations Manager

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 Biomarker Operations Manager to join our growing Translational Medicine team. The candidate will lead, oversee and execute biomarker operations in support of global clinical studies. The Biomarker Operations Manager will be responsible for the chain of custody of biomarker specimens and will establish and maintain best practices in biospecimen management to ensure compliance with regulatory guidance. The individual may also assist the team in developing biomarker plans, including the strategy and goals, experimental validation, timelines and budget. As a member of the clinical study team, the ideal candidate will be experienced in collaborating cross functionally to support different aspects of biomarker operations for IND enabling studies and clinical trial execution.  The role can be based remotely or near any of Chinook’s sites in Oakland, San Diego, Vancouver, or Seattle.

 

Responsibilities include:

 

  • Plans, coordinates, and oversees biomarker sample management to ensure delivery of sample testing and data milestones
  • Coordinate sample logistics and communications between sponsor, sites, and specialty labs to ensure clinical biomarker 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 metrics to clinical study teams
  • Collaborate with study team, clinical sites, and CROs to resolve discrepancies/lab queries
  • Contribute to biomarker 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 and knowledge of clinical trial workflow in pharmaceutical/biotech required
  • 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 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