Associate Director, Supply Chain Management

CMC (700) · Seattle, Washington
Department CMC (700)
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor

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:

 

The Associate Director, Clinical Supply is responsible for management of the supply chain for a portfolio of global clinical studies across all phases of development through collaboration with various functions including external CRO’s and CMO’s. This position will lead and oversee all aspects of clinical supply management including forecasting, labeling, distribution, monitoring inventory and vendor oversight. This is an office-based position in our Seattle location with occasional travel both domestic and international.

 Responsibilities include:

  • Create and implement a global distribution and logistics strategy
  • Develop and manage forecasts for clinical supply demand
  • Manage clinical supply planning process including but not limited to shelf-life extension, scenario planning and inventory movement
  • Work collaboratively with CMC and manufacturing to ensure sufficient drug product to meet all supply chain requirements
  • Collaborate with Clinical Operations and other internal departments to design and build IRT systems.
  • Management of manual clinical supply drug orders
  • Collaboration with internal CMC functions for seamless expiry management at clinical sites and depots
  • Perform the investigational labeling process from development of master text through translations, review, and proofing
  • Develop the spend forecast for clinical packaging, labeling, and distribution costs.
  • Manage timelines and budgets to ensure on-time and on-budget delivery of product to clinical sites, raising risks proactively
  • Manage vendor relationships including contracts and invoices
  • Review and approve documentation related to packaging, labeling, and distribution of clinical supply.
  • Maintain supply chain documentation within eTMFs as required
  • Track recruitment and adjust supply plans to accommodate changes in study.
  • Identify and author SOP’s
  • Other duties as assigned


Education, Experience, and Skills:

  • Master’s with 10 years of experience, or a Bachelor’s degree with 15+ years of pharmaceutical industry experience working in a supply chain function.
  • Thorough understanding of good manufacturing practices, and current industry practices for clinical and commercial supply 
  • Experience in managing global clinical trials, including management of CROs, CMOs
  • Well-versed on global regulatory requirements for the drug development process
  • Experience authoring and reviewing technical documents including, but not limited to, master and executed batch records, validation reports and specifications
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
  • Strong track record of good project management
  • Thinks critically and creatively and can work independently in a fast-paced dynamic environment with multiple projects
  • Ability to effectively organize and prioritize tasks to achieve established deadlines
  • Excellent written, communication, and problem-solving skills

 

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
    CMC (700)
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor