Clinical Quality Operations Specialist

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

Clinical Quality Operations Specialist:

 

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:

 

As a key member of the Clinical team, the Clinical Quality Operations  (CQO) Specialist is responsible for partnering across functions to help build and maintain a continuous improvement culture, driving  fit-for-purpose process development and improvement, supporting procedural change management, and conducting various quality checks on internal processes. The CQO Specialist will support onboarding, training, and manage assigned inspection-readiness activities as well as other duties as assigned. The CQO Specialist position reports to the Director of Clinical Operations and is based in Seattle Washington.

 

 

 Responsibilities include:

  • Support the clinical infrastructure team
    • Coordinate and lead regular cross-functional team meetings in support of the life-cycle management of GxP SOPs, Work Processes, and Forms with a primary focus on the content necessary for the execution of clinical trials
    • Assure fit-for-purpose process development that is congruent with corporate goals as well as regulatory and industry best practice
    • Build quality checks into clinical processes as appropriate
  • Manage clinical document control for clinical Forms and Work Processes
    • Contribute to regular clinical quality process and procedure review
  • Perform quality checks of various clinical activities to ensure systems and processes are working
    • Propose, develop, and implement mitigations as needed
  • Conduct ongoing and proactive risk identification and mitigation
  • Own and generate key clinical quality and performance metrics and reporting
  • Foster a continuous improvement culture
  • Support inspection-readiness activities as assigned
  • Keep pace with regulatory and industry changes particularly related to ICH GCP and CFR
  • Support the build out, implementation and maintenance of clinical systems
  • Support and participate in internal process audits conducted by Quality Assurance
  • Perform GxP activities as assigned
  • Contribute to vendor qualification activities as assigned
  • Ensure clinical department onboarding, training compliance and reporting
  • Contribute to the development and maintenance of a positive team-focused company culture

 

Education, Experience, and Skills:

  • Bachelor’s degree or higher or equivalent experience
  • At least 5 years experience in clinical operations, clinical trial management, or clinical quality in the pharmaceutical or biotech industry
  • Deep knowledge and understanding of ICH GCP regulatory obligations as well as the Code of Federal Regulations, especially Part 21
  • Experience with and affinity for clinical systems (e.g., eTMF, CTMS, EDC, IRT, CMS)
  • Highly motivated and enthusiastic, a champion for process and people
  • Able to establish and maintain positive and productive relationships
  • Strong and affirming communication skills – diplomatic and tactful
  • Solid analytical, negotiations, and problem-solving skills
  • Exposure to and high-level understanding of quality systems
  • Able to independently coordinate, lead, and manage cross functional initiatives
  • An effective change manager, supportive, and empathetic particularly to those for whom change is difficult, and able to reinforce Chinook’s business needs
  • FDA, EMA inspection experience preferred

 

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
    Entry-level