Clinical Project Manager

· Seattle, Washington
Employment Type Full-Time
Minimum Experience Mid-level

Chinook Therapeutics Job Description: 

Clinical Project Manager

 

Company:

 

Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for patients with kidney diseases. We apply our proprietary research platform to discover and develop therapies with novel mechanisms of action in key kidney disease pathways. Our development focus is on rare, serious disorders with clear unmet medical needs and well-defined clinical development opportunities. Our lead program, atrasentan, is a potent and selective, small molecule inhibitor of the endothelin A receptor that is planned to move into a phase 3 registrational trial for IgA nephropathy and a phase 2 basket trial for glomerular diseases, in 2021. We are advancing BION-1301, an anti-APRIL monoclonal antibody, in an ongoing phase 1b trial for IgA nephropathy, and CHK-336, an oral small molecule LDHA inhibitor for primary hyperoxaluria, towards trial initiation in 2021. Our pipeline also includes several additional preclinical programs at the validation and lead optimization stages, and we continue to actively evaluate business development opportunities around early and late-stage clinical assets in kidney disease. 

 

Chinook completed the third quarter of 2020 with over $290 million in operating capital and trades on Nasdaq under the ticker symbol, “KDNY.”  The company 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 facilitation of cross-functional activities, establishment and maintenance of project milestones, timelines, budgets and trial related forecasts. This position reports to the Associate Director, Clinical Project Management and is based in Chinook’s Seattle location.

 

 Responsibilities include:

 

  • Champion study priorities and healthy team dynamics
  • Facilitate cross-functional study teams in the timely delivery of clinical trials
  • Assist in development of study design, documents, and plans (e.g., protocol, IB, CSR, etc.)
  • Track and help drive development to completion within timelines
  • Support development of comprehensive study budgets in partnership with CTM and other functions as relevant and help the team manage costs to established budgets
  • Develop study-related forecasts (e.g., site activation, enrollment, drug supply, spend, team performance, etc.)
  • Establish and maintain comprehensive timelines for each study, and uses these timelines to help drive study team activities
  • Collaborate with Program Manager to ensure alignment of clinical project timelines, risk and budgets with higher-level program timelines, risks and budgets
  • Initiate and/or facilitate RFI, RFP, and other vendor management and oversight activities
  • Contribute to development and implementation of 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, etc.)
  • Facilitate ongoing risk management activities including identification and tracking of risks/issues
  • Facilitate cross-functional team meetings and vendor meetings
  • Establish, review and track Key Performance Indicators /metrics for performance and quality
  • Negotiate and manage competing priorities across functions to ensure on time, within spec delivery
  • May manage, coordinate, and oversee vendors involved in the clinical study, e.g. central lab, CROs
  • Prepare reports (financial, project, etc.) for management on project 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 6 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
  • Must have clinical trial experience
  • Project management training and knowledge of project management methodologies and tools
  • Experience forecasting and managing clinical 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
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level