Clinical Project Manager

Clinical Ops (600) · Seattle, Washington
Department Clinical Ops (600)
Employment Type Full-Time
Minimum Experience Experienced

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 1b 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 Berkeley, CA.


Position:

Chinook has an exciting opportunity for an experienced Clinical Project Manager who will support planning and execution of clinical trials with a primary focus on facilitating cross-functional activities, establishing and maintaining project milestones, timelines, and study forecasts. This position reports to the Associate Director, Clinical Project Management or above.

 

 Responsibilities include:

  • Champion study priorities and healthy team dynamics
  • Facilitate cross-functional study teams in the timely delivery of clinical trials
  • Develop comprehensive cross-functional study budgets in partnership with study team members as relevant and help the team manage costs to established budgets
  • Develop and maintain study forecasts (e.g., enrollment, drug supply, spend, team performance, etc.)
  • Establish and maintain comprehensive cross-functional study, and uses these timelines to help drive study team activities
  • Initiate and facilitate RFI, RFP, and other vendor management and oversight activities
  • Contribute to development and implementation of study design, IB, protocols and various cross-functional study plans and materials (e.g., CRO oversight plans, vendor oversight plans, communication plans, data management plans, safety management plans, IND safety report distribution, CSR, etc.)
  • Facilitate ongoing risk management activities
  • Facilitate cross-functional internal team meetings and vendor meetings
  • Establish and review Key Performance Indicators /metrics for performance and quality
  • Negotiate and manage competing priorities across functions to ensure on time, within spec delivery
  • Manage, coordinate, and oversee vendors involved in the clinical study, e.g. central lab, CROs
  • Prepare reports (financial, project, etc.) for management on program status
  • Ensure study activities are conducted in compliance with applicable regulations
  • Actively learn and increase understanding and awareness related to drug development, clinical trials, related regulations, study indications, scientific understanding, and trial related technology solutions
  • Contribute to the development and maintenance of a positive team-focused company culture

 

Education, Experience, and Skills:

  • Bachelor's degree or equivalent, preferably in a health, science, finance, or business-related field
  • At least 8 years prior work experience with at least 2 years experience as a project coordinator or project manager, preferably in a biotech, pharmaceutical, health, science, finance, or business-related field.
  • Project management training and knowledge of project management methodologies and tools
  • Experience forecasting and managing project budgets preferred
  • Vendor contracting and management experience
  • Knowledge and understanding of research regulatory guidelines and policies, i.e., GCP/ICH, the Code of Federal Regulations as well as other global regulations
  • Highly effective written/verbal communication skills
  • Proficiency with MS Word, Excel, Outlook, PowerPoint, SharePoint, OneNote
  • Demonstrated Proficiency with either SmartSheet or MS project and has experience developing comprehensive study/project timelines (e.g., study concept through CSR)
  • Willingness and ability to travel globally up to 30%
  • Demonstrated strategic and tactical abilities


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
    Clinical Ops (600)
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced